State Standard of Rostekhregulirovaniya dated March 01, 2010 No. GOST R ISO 6710-2009

GOST R ISO 6710-2009 Disposable containers for collecting venous blood samples. Technical requirements and test methods

Adopted on July 03, 2009
Federal Agency for Technical Regulation and Metrology

GOST R ISO 6710-2009
Group R29
NATIONAL STANDARD OF THE RUSSIAN FEDERATION
CONTAINERS FOR COLLECTION OF SAMPLES OF VENOUS BLOOD, DISPOSABLE
Technical requirements and test methods
Single-use containers for venous blood specimen collection. Technical requirements and test methods
OKS 11.040.20
OKP 94 4470
Introduction date 2010-03-01
Foreword
The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On Technical Regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"
About the standard
1 PREPARED by the Laboratory for Clinical and Laboratory Diagnostic Problems of the Research Center of the State Educational Institution of Higher Professional Education "Moscow Medical Academy named after I.M. Sechenov of the Ministry of Health and Social Development of the Russian Federation" based on our own authentic translation of the standard specified in paragraph 4
2 INTRODUCED by the Technical Committee for Standardization TC 466 "Medical Technologies"
3 APPROVED AND PUT INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology dated July 3, 2009 N 232-st
4 This International Standard is identical to ISO 6710:1995 "Single-use containers for venous blood specimen collection".
The name of this standard has been changed relative to the name of the specified international standard to bring it into line with GOST R 1.5 (clause 3.5).
When applying this standard, it is recommended to use instead of the reference international (regional) standards the corresponding national standards of the Russian Federation, details of which are given in Appendix F
5 INTRODUCED FOR THE FIRST TIME
Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet
AMENDED, published in IUS N 12, 2009
Amended by database manufacturer
1 area of use
This International Standard specifies requirements and test methods for vacuum and non-vacuum disposable containers for the collection of venous blood samples. It does not establish requirements for blood collection needles and needle holders.
NOTE This International Standard replaces the requirements for non-vacuum containers previously specified in ISO 4822 Disposable blood collection containers up to 25 ml capacity, which has been withdrawn.
2 Normative references
This International Standard makes reference to the following International Standards:
ISO 594-1:1986 Conical devices with 6% (Luer) constriction for syringes, needles and certain other equipment. Part 1. General requirements
ISO 3696:1987 Water for laboratory analysis. Technical requirements and test methods
ISO 7000:1989* Graphical symbols for application to equipment. Index and summary
3 Terms and definitions
In this standard, the following terms are used with their respective definitions:
3.1 container
3.2 evacuated container container designed to draw blood by means of a vacuum created by the manufacturer (i.e. pre-vacuum container) or by the user prior to drawing blood
3.3 tube
3.4 closure
3.5 primary pack direct packaging of containers
3.6 container interior inner surface of a container
3.7 additive
3.8 nominal capacity volume of whole blood with which the container is intended to be filled
3.9 free space excess capacity or head space that is created to ensure adequate mixing of the contents of a container as determined by the minimum free space tests given in Annexes A and B
3.10 fill line line marked on the vial and on its label to indicate the nominal capacity of the container
3.11 draw volume nominal capacity of the vacuum container
3.12 expire date date after which the manufacturer cannot guarantee the conformity of the container with the requirements of this standard
3.13 closing torque torque, specified by the manufacturer, required to close a stopper tightly with a wrench to seal a container tightly
3.14 visual inspection inspection by an observer with normal or normal corrected vision in uniform illumination between 300 and 750 lux
4 Materials
4.1 The tube must be made of a material that allows the contents of the container to be clearly seen by visual inspection.
It is recommended that the inner surface of glass tubes intended for specimens to be used in blood coagulation studies should not cause contact activation (see ).
4.2 If a container is specifically designed to test a particular substance, the maximum level of contamination of the inside of the container with that substance and the analytical method used should be specified by the manufacturer in the accompanying information, on the label or on the packaging (see also 10.4).
In the case of using a sample for the study of certain metals and other well-defined substances, the formula of the composition of the plug material should be such that there is no interference that affects the results.
NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may not be an agreed interference limit. In such cases, the user is advised to consult the manufacturer.
4.3 Containers containing microorganism-preserving additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to prevent microbial contamination of the additive and the interior of the container.
NOTE It is the responsibility of the manufacturer to validate the process. This International Standard does not specify a validation procedure, but a related standard is under development.
4.4 The container must be free from foreign objects during visual inspection.
5 Capacity
5.1 When tested in accordance with the methods given in Annexes A and B, the volume of water added to or drawn from the burette shall be within ±10% of the rated capacity.
5.2 In order to carry out the tests in accordance with the methods given in Annexes A and B, containers of additives shall be provided with sufficient free space to ensure adequate mixing by mechanical and manual means. The minimum headspace to allow adequate mixing should be as given in Table 1. It must be assumed that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid.
Table 1 - Values for the minimum free space to allow adequate mixing
6 Device
6.1 The closure of the container shall not be compromised by mixing during the leak test in accordance with the methods specified in Annex C.
6.2 When the cork is removed to gain access to the contents of the container, it must be possible to remove it with the fingers or mechanically so that the part of the cork contaminated with the contents of the container does not come into contact with the fingers.
NOTE Some devices, such as blood cell counters, are designed to be able to aspirate the contents of a blood sample container without removing the stopper.
6.3 When testing a container for leakage in accordance with the method specified in Annex C, no fluorescence of the water in which the container is immersed shall be observed.
7 Design
7.1 When tested in accordance with the method specified in Annex D, the sample container shall withstand an acceleration of up to 3000 along the longitudinal axis during centrifugation.
Note - 9.806 65 m/s.
7.2 Visual inspection of the container shall show no sharp edges or rough surface capable of inadvertently cutting, pricking or abrading the user's skin.
8 Sterility
8.1 If the manufacturer guarantees that the product is sterile, the interior of the container and any of its contents must be subjected to a verification process designed to confirm that the interior of an unopened and unused container and any of its contents are sterile.
NOTE It is the manufacturer's responsibility to verify the effectiveness of the process. This International Standard does not specify a verification process procedure, but a standard for control methods and sterilization confirmation processes is being developed. In the absence of national regulation, refer to the current European Pharmacopoeia, the current USP or the current British Pharmacopoeia.
8.2 Sterility is required when blood is drawn in direct contact between the inside of the container and the patient's bloodstream.
9 Additives
9.1 The specified nominal amount of additive should be within the limits specified in Annex E.
NOTE With one exception (see 9.2), test methods are not specified.
In the presence of sodium, potassium or lithium in the additive, it is recommended to use flame photometry. It is important that the accuracy of the test is within the error limits given in Annex E. If the test method is non-specific, such as flame photometry for sodium and potassium salts of ethylenediaminetetraacetic acid, an identification test is recommended.
9.2 The volume of the liquid additive in the container must be determined gravimetrically, corrected for the relative density of the liquid.
10 Markings and labels
10.1 The label should not completely cover the vial.
10.2 Marking and label should remain attached to the container after exposure to air at a temperature of (4 ± 1) °C for at least 48 hours.
NOTE This subclause specifies requirements for a product under normal conditions. However, when the product is stored or used under extreme conditions (extreme temperature or humidity, or abnormal transportation, or long-term storage), the requirements may not be adequate. The manufacturer is responsible for ensuring that the product is suitable for storage or use under abnormal or abnormal conditions.
10.3 The marking on the outside of each primary packaging must contain the following information:
a) name and address of manufacturer and supplier;
b) lot number;
c) expiration date;
d) a description of the content, which should include:
- nominal capacity;
- coating (eg non-contact activation) or additives in all tubes;
- names of additives or their formulas and/or letter code given in Table 2;
- the inscription "sterile", if the manufacturer guarantees that the interior of the unopened container and its contents are sterile;
- the inscription "one-time" or a graphic symbol in accordance with ISO 7000;
- storage requirements.
10.4 If the container is specifically for testing a particular substance, the maximum contamination level for that substance should be indicated on the label or on the primary packaging.
10.5 Containers shall bear the following information, either directly on the tube or on a label:
a) name or trademark of the manufacturer or supplier;
b) lot number;
c) letter code (see Table 2) and/or description of contents;
d) expiration date;
e) nominal capacity;
f) filling line, if necessary, eg for non-vacuum containers;
g) the inscription "sterile" if the manufacturer guarantees that the interior of the unopened and unused container and its contents are sterile.
If glycerin has been used in the manufacture of the container, this must be indicated on the label or on the packaging.
11 Container identification
Containers must be identified by the letter code and/or additive description given in Table 2. If additives other than those listed in Table 2 are used, containers must be identified by the additive description.
NOTE 1 There is currently no international agreement on color coding.
NOTE 2 When color coding is used, the codes shown in Table 2 are recommended.
NOTE 3—When color coding is used, it is recommended that the color of the stopper match the color of the tube or label.
Table 2 - Letter codes and recommended color codes for identifying additives

Additives Letter codes Recommended color codesEDTAdipotassium salt K2E Pale lilac colortripotassium salt K3E Pale lilac colordisodium salt N2E Pale lilac colorTrisodium Citrate 9:1 9NC Pale BlueTrisodium citrate 4:1 4NC Black colorFluoride/Oxalate FX GrayFluoride/EDTA FE Gray colorFluoride/Heparin FH GreenLithium Heparin LH GreenSodium heparin NH Green colorCitrate Phosphate Dextrose Adenine CPDA YellowNothing Z Red

EDTA is a practical abbreviation for ethylenediaminetetraacetic acid instead of the correct systematic name, i.e. (ethylenediaminetetraacetic acid). The ratio between the desired volumes of blood and liquid anticoagulant is noted (eg, 9 volumes of blood to one volume of citrate solution). It is recommended that blood clotting accelerator containers be identified by the letter code Z and have a red color code with a description of the additive.

Annex A
(mandatory)
Nominal capacity and minimum free space tests for non-vacuum containers
A.1 Reagents and equipment
A.1. 1 Water, in accordance with ISO 3696, temperature 20°C-25°C.
A.1. 2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accurate to ±0.1 ml), with a tip at the bottom or side.
A.2 Test conditions
A.2. 1 Tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.
A.2. 2 Unused containers should be tested.
A.3 Test procedure
A.3. 1 Close the tip of the burette and fill it with water.
A.3. 2 Place an open container under the outlet tap of the burette and carefully pour water into the container until the water meniscus reaches the level of the filling line, then close the tap.
A.3. 3 Record the volume of water released from the burette.
A.3. 4 Continue pouring water from the burette until the water level reaches the neck of the test tube and note the volume of water dispensed to the nearest ±0.1 ml.
A.4 Test criteria
A.4. 1 The container must pass the nominal capacity test if the volume of water dispensed from the burette corresponds to the nominal capacity ±10%.
A.4. 2 The container shall pass the minimum headspace test if, assuming that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than that indicated in Table 1 for containers of the type tested.
Annex B
(mandatory)
Retracted (sucked) volume and minimum free space tests for vacuum containers
B.1 Reagents and equipment
IN 1. 1 Water, in accordance with ISO 3696, temperature 20°C-25°C.
IN 1. 2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accurate to ±0.1 ml), with a tip at the bottom or side.
IN 1. 3 Clear silicone rubber tube (short).
IN 1. 4 Blood collection needles as recommended by container manufacturer.
IN 1. 5 Holder as recommended by the container manufacturer.
B.2 Retracted (sucked in) volume test
AT 2. 1 Test conditions
B.2.1. 1 Tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.
B.2.1. 2 Unused containers should be tested.
AT 2. 2 Test procedure
B.2.2. 1 Assemble the product, if supplied unassembled, insert the needle into the holder according to the container manufacturer's instructions.
B.2.2. 2 Fill the burette with water, open the burette cock and let the water through the silicone rubber filling clamp; leave the burette empty.
B.2.2. 3 Insert the outer needle of the blood collection needle/needle holder assembly through the wall of the silicone tubing until the needle enters the lumen of the tubing.
B.2.2. 4 Connect the container to the needle/holder assembly according to the container manufacturer's instructions.
B.2.2. 5 Fill the container for at least one minute or as directed by the manufacturer.
B.2.2. 6 Align the meniscus and read the retracted volume of liquid to within ±0.1 ml of the height of the meniscus in the burette.
AT 2. 3 Test criteria
The container may pass the test if the volume of water drawn in is ±10% nominal capacity.
B.3 Minimum clearance test
AT 3. 1 Test conditions
B.3.1. 1 Tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.
B.3.1. 2 Unused containers should be tested.
AT 3. 2 Test procedure
B.3.2. 1 Remove the silicone tubing from the burette outlet valve with the valve closed and fill the burette with water if necessary.
B.3.2. 2 Place an open tube under the burette outlet valve.
B.3.2. 3 Pour water until the water level reaches the neck of the test tube.
B.3.2. 4 Record the volume of water released to the nearest ±0.1 ml.
Determine the minimum headspace by subtracting the volume of water drawn in during the volume draw test (see B.2) from the total volume of water drawn from the burette.
AT 3. 3 Test criteria
The container is considered to have passed the test if, assuming that the free space available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than indicated in Table 1 for containers of the type tested.
NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding part of the cork or the excess volume due to the concave shape of the cork.
Appendix C
(mandatory)
Container leak test
C. 1 Reagents
C.1. 1 Solution prepared by dissolving 2.5 g of sodium fluorescein [uranine, CAS number 518-47-8]* in 100 ml of 0.15 mol/l sodium chloride solution containing 60 g/l of dextran 70 [CAS number 9004- 54-0], or equivalent.

______________
* CAS number means Chemical Abstracts Service Registry number.

C.1. 2 Deionized water that does not fluoresce when viewed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected to normal vision without special instruments.
C. 2 Equipment
C.2. 1 Reservoir (for sodium fluorescein reagent) connected to a plastic tube of sufficient length (1 m). When testing a vacuum container, the tubing should be connected to a blood collection needle as recommended by the manufacturer. When testing other containers, the tubing shall be connected to a hollow end of rigid material which terminates in a conical constriction bonded to a 6% Luer fitting conforming to ISO 594-1.
C.2. 2 Source of long-wave ultraviolet light.
C.2. 3 Roller-type mixer or other mixer recommended by the container manufacturer.
C.2. 4 Wrench (if necessary).
C.3 Test procedures for non-vacuum containers
C.3. 1 Fill the reservoir with reagent (C.1.1).
C.3. 2 Remove the stopper from the tube and fill it up to the nominal capacity from the reservoir, avoiding contamination of the outer surface and edge of the tube with the reagent. Insert the plug as directed by the manufacturer. Tighten the screw cap to the torque specified by the manufacturer. Insert the cap firmly into place in the neck of the test tube. Insert the cover cap into place over the edges of the tube.
C.3. 3 With normal or corrected to normal vision without magnification, examine the container in a darkened room to ensure that its surface is not contaminated with reagent. If necessary, wash off contamination with water and examine under ultraviolet light as above.
C.3. 4 Roll the container on a roller mixer for 2 minutes or mix the contents as directed by the container manufacturer. Completely submerge the container in a vessel containing no more than 100 ml of water so that the water completely covers the cork. Leave the container in water at a temperature of 15°C to 20°C for 60 minutes. Remove the container from the water and examine the water under ultraviolet light as described in C.3.3.
C.4 Test procedure for vacuum containers
C.4. 1 Fill the reservoir with reagent (C.1.1).
C.4. 2 Fill the container to its nominal capacity from the reservoir connected to the blood collection needle, avoiding contamination of the outer surface of the container with the reagent. After filling the container, separate it from the needle and, having washed the outer part of the test tube and stopper from possible contamination by the reagent, examine it in ultraviolet light as described in C.3.3.
C.4. 3 Carry out the procedures described in C.3.4.
C.5 Procedure for containers to be filled either by perforating the stopper or after removing the stopper
C.5. 1 Fill the reservoir with reagent (C.1.1).
C.5. 2 Fill as indicated below.
a) Filling by perforating the cork
Carefully insert the rigid tip of the tubing through the portion of the stopper intended to be perforated and fill the container to its nominal capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, remove it from the hard tip and, having washed the tube and stopper from possible contamination by the reagent, examine the container in ultraviolet light, as indicated in C.3.3.
b) Filling after removing the stopper.
Use the method described in C.3.2 and C.3.3.
C.5. 3 Follow the procedures described in C.3.4.
C.6 Test criteria
The container is deemed to have passed the test if no fluorescence is detected in the water.
Appendix D
(mandatory)
Container strength test
D.1 Reagents and equipment
D.1. 1 Test fluid having the same relative density as normal human blood.
D.1. 2 Blood sample container.
D.1. 3 Centrifuge capable of subjecting the base of the container to a centrifugal acceleration of up to 3000 for 10 minutes.
D.2 Test procedure
D.2. 1 Fill the container with test liquid using the method specified by the manufacturer, removing the plug and replacing it if necessary.
D.2. 2 Make sure the container is correctly placed and balanced in the centrifuge.
D.2. 3 Centrifuge the filled container by subjecting its base to a centrifugal acceleration of 3000 for 10 min, then carefully place it in the rack and inspect.
D.3 Test criteria
The container is considered to have passed the test if the container does not break, leak or crack.
Annex E
(mandatory)
Additive Concentrations and Liquid Additive Volume
E. 1 Salts of ethylenediaminetetraacetic acid
[(EDTA) ((CH2N(CHCOOH)]; CAS No. 60-00-4)]
The concentrations of dipotassium salt [CAS number 25102-12-9], tripotassium salt [CAS number 17572-97-3], and disodium salt [CAS number 6381-92-6] should be between 1.2 and 2 mg anhydrous EDTA per 1 ml of blood [EDTA calculated as the anhydrous salt of the isolated acid (0.004 11 mol/l to 0.006 843 mol/l)]. Appropriate allowance must be made to compensate for the salt actually used for its water of crystallization.
E. 2 Trisodium citrate
E.2. 1 The concentration of trisodium citrate should be in the range from 0.1 to 0.136 mol/l of solution. The allowable tolerance for the specific amount of additive should be ±10%.
E.2. 2 For coagulation studies: 9 volumes of blood must be added to 1 volume of trisodium citrate solution.
E.2. 3 Erythrocyte sedimentation rate according to the Westergren method: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.
E. 3 Fluoride/oxalate
Concentrations should be between 1 and 3 mg potassium oxalate monohydrate [CAS number 6487-48-5] (0.0039334 mol/l to 0.001 1 mol/l) and between 2 and 4 mg sodium fluoride [CAS number 7681- 49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.
E. 4 Fluoride/EDTA
Concentrations should be in the range of 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.
E. 5 Fluoride/heparin
Concentrations should be in the range of 12 to 30 international units of heparin and 2 to 4 mg of fluoride per ml of blood.
E. 6 Sodium/Heparin [CAS Number 9041-08-1] Lithium/Heparin [CAS Number 9045-22-1]
Concentrations should be between 12 and 30 international units per ml of blood.
E. 7 Citrate phosphate dextrose adenine (CPDA)
E.7. 1 The formula should be as follows:
Citric Acid (Anhydrous) [CAS Number 77-92-9] 2.99 gTrisodium citrate (dihydrate) [CAS number 77-92-9] 26.3 g Monobasic sodium phosphate 2.22 g Dextrose (monohydrate) [CAS number 5996-10-1] 31.9 g Adenine 0.275 g Water for injection, sufficient amount up to 1000 ml.
E.7. 2 Six volumes of blood should be added to one volume of CPDA solution.
E.7. 3 The allowed tolerance to the specified amount of additive should be within ±10%.
NOTE Additives can be presented in various physical forms, for example, as a solution, dry residue from a solution, evaporated by heating, lyophilized or in powder form. Concentration limits are allowed for the different solubility and diffusion rates of these different forms, especially for EDTA.
Appendix F
(reference)
Information on the compliance of the national standards of the Russian Federation with reference international standards
Table F.1
Bibliography
Recommended methodology for the use of International Reference Thromboplastin Preparations. 1983, World Health Organization, Geneva, Switzerland (Recommended methodology for using International Reference Preparations for Thromboplastin, 1983, World Health Organization, Geneva, Switzerland)International Committee for Standardization in Hematology. 1977, Recommendation for measurement of erythrocyte sedimentation rate of human blood (International Committee for Standardization in Haematology, 1977), American Journal of Clinical Pathology, 68, 1977, pp.505-507Anticoagulant citrate phosphate dextrose adenine in solution. Pharmacopoeia of the United States of America. national forms. 1990, pp. 101-102 (Anticoagulant Citrate Phosphate Dextrose Adenine Solution, pp. 101-102. The United States Pharmacopoeia. The National Formulary, USP XXII, NF XVII, 1990, United States Pharmacopoeial Convention, Inc., Rockville, MD, USA)

GOST ISO 6710-2011

INTERSTATE STANDARD

CONTAINERS FOR COLLECTION OF SAMPLES OF VENOUS BLOOD, DISPOSABLE

Technical requirements and test methods

Single-use containers for venous blood specimen collection. Technical requirements and test methods

ISS 11.040.20

Introduction date 2013-01-01

Foreword

The goals, basic principles and procedure for carrying out work on interstate standardization are established by GOST 1.0-92 "Interstate standardization system. Basic provisions" and GOST 1.2-2009 "Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. Rules for the development, adoption, application , updates and cancellations"

About the standard

1 PREPARED BY Federal State Unitary Enterprise "All-Russian Research Institute for Standardization and Certification in Mechanical Engineering" (VNIINMASH)

2 INTRODUCED by the Federal Agency for Technical Regulation and Metrology (Rosstandart)

3 ADOPTED by the Interstate Council for Standardization, Metrology and Certification (Minutes of November 29, 2011 N 40)

Voted for the adoption of the standard:


Short name of the country according to MK (ISO 3166) 004-97		Abbreviated name of the national standards body
Belarus		State Standard of the Republic of Belarus
Kazakhstan		State Standard of the Republic of Kazakhstan
Kyrgyzstan		Kyrgyzstandart
Russian Federation		Rosstandart
Uzbekistan		Uzstandard
Tajikistan		Tajikstandart

4 By order of the Federal Agency for Technical Regulation and Metrology dated December 13, 2011 N 1379-st, the interstate standard GOST ISO 6710-2011 was put into effect as the national standard of the Russian Federation from January 1, 2013.

5 This standard is identical to ISO 6710:1995* Single-use containers for venous blood specimen collection.
________________
* Access to international and foreign documents mentioned hereinafter in the text can be obtained by clicking on the link to the site http://shop.cntd.ru. - Database manufacturer's note.

The degree of conformity is identical (IDT).

The standard has been prepared based on the application of GOST R ISO 6710-2009

Information on the compliance of interstate standards with reference international standards is given in the additional appendix YES

6 INTRODUCED FOR THE FIRST TIME

Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information index "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet

1 area of use

This International Standard specifies requirements and test methods for vacuum and non-vacuum disposable containers for the collection of venous blood samples. It does not establish requirements for blood collection needles and needle holders.

NOTE This International Standard replaces the requirements for non-vacuum containers previously specified by ISO 4822 Disposable Blood Sample Collection Containers up to 25 ml, which has been withdrawn.

2 Normative references

This International Standard uses references to the following International Standards*:
____________
* See the link for the table of correspondence between national standards and international standards. - Database manufacturer's note.

ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements Part 1. General requirements)

ISO 3696:1987 Water for analytical laboratory use - Specification and test methods

ISO 7000:1989* Graphical symbols for use on equipment - Index and synopsis
_______________
* Since February 19, 2004, ISO 7000:2004 is valid.

3 Terms and definitions

In this standard, the following terms are used with their respective definitions:

3.1 container(container): A container for a blood sample sealed with a stopper.

3.2 vacuum container(evacuated container): A container designed to draw blood using a vacuum created by the manufacturer (i.e., a pre-vacuum container) or user prior to drawing blood.

3.3 test tube(tube): The part of the container without the cork that contains the sample.

3.4 cork(closure): The part with which the container is closed.

3.5 primary packaging(primary pack): Direct packing of containers.

3.6 container interior(container interior): The interior surface of a container.

3.7 additive(additive): Any substance (not bound to the interior surface of the container) placed in the container to enable the intended analysis to be performed.

3.8 nominal capacity(nominal capacity): Volume of whole blood to be filled in the container.

3.9 free space(free space): Excess capacity or head space that is created to ensure adequate mixing of the contents of the container, as determined by the minimum free space tests given in Annexes A and B.

3.10 filling line(fill line): A line marked on a vial and on its label to indicate the nominal capacity of the container.

3.11 suction volume(draw volume): Rated capacity of the vacuum container.

3.12 best before date(expire date): The date after which the manufacturer cannot guarantee the conformity of the container with the requirements of this standard.

3.13 twist plugging(closing torque): Torque, specified by the manufacturer, required to close a cork tightly with a wrench to seal a container tightly.

3.14 visual inspection(visual inspection) inspection by an observer with normal or corrected to normal vision in uniform illumination between 300 and 750 lux.

4 Materials

4.1 The tube must be made of a material that allows the contents of the container to be clearly seen by visual inspection.

It is recommended that the inner surface of glass tubes intended for specimens to be used in blood coagulation studies should not cause contact activation (see ).

4.2 If a container is specifically designed to test a particular substance, the maximum level of contamination of the interior of the container with that substance and the analytical method used should be specified by the manufacturer in the accompanying information, on the label or on the packaging (see also 10.4).

In the case of using a sample for the study of certain metals and other well-defined substances, the formula of the composition of the plug material should be such that there is no interference that affects the results.

NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may not be an agreed interference limit. In such cases, the user is advised to consult the manufacturer.

4.3 Containers containing microorganism-preserving additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to prevent microbial contamination of the additive and the interior of the container.

NOTE It is the responsibility of the manufacturer to validate the process. This International Standard does not specify a validation procedure, but a related standard is under development.

4.4 The container must be free from foreign objects during visual inspection.

5 Capacity

5.1 When tested in accordance with the methods given in Annexes A and B, the volume of water added to or drawn from the burette shall be within ±10% of the rated capacity.

5.2 In order to carry out the tests in accordance with the methods given in Annexes A and B, containers of additives shall be provided with sufficient free space to ensure adequate mixing by mechanical and manual means. The minimum headspace to allow adequate mixing should be as given in Table 1. It must be assumed that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid.

Table 1 - Values for the minimum free space to allow adequate mixing


Nominal container capacity, ml	Minimum free space value
>0.5 and<5,0	25% of nominal capacity
	15% of nominal capacity

6 Device

6.1 The closure of the container shall not be compromised by mixing during the leak test in accordance with the methods specified in Annex C.

6.2 When the cork is removed to gain access to the contents of the container, it must be possible to remove it with the fingers or mechanically so that the part of the cork contaminated with the contents of the container does not come into contact with the fingers.

NOTE Some instruments, such as blood cell counters, are designed to be able to aspirate the contents of a blood sample container without removing the stopper.

6.3 When testing a container for leakage in accordance with the method specified in Annex C, no fluorescence of the water in which the container is immersed shall be observed.

7 Design

7.1 When tested in accordance with the method specified in Annex D, the sample container shall withstand an acceleration of up to 3000 along the longitudinal axis during centrifugation.

Note - = 9.80665 m/s.

7.2 Visual inspection of the container shall show no sharp edges or rough surface capable of inadvertently cutting, pricking or abrading the user's skin.

8 Sterility

8.1 If the manufacturer guarantees that the product is sterile, the interior of the container and any of its contents must be subjected to a verification process designed to confirm that the interior of an unopened and unused container and any of its contents are sterile.

NOTE It is the manufacturer's responsibility to verify the effectiveness of the process. This International Standard does not specify a verification process procedure, but a standard for control methods and sterilization confirmation processes is being developed. In the absence of national regulation, refer to the current European Pharmacopoeia, the current USP or the current British Pharmacopoeia.

8.2 Sterility is required when blood is drawn in direct contact between the inside of the container and the patient's bloodstream.

9 Additives

9.1 The specified nominal amount of additive should be within the limits specified in Annex E.

NOTE With one exception (see 9.2), test methods are not specified.

In the presence of sodium, potassium or lithium in the additive, it is recommended to use flame photometry. It is important that the accuracy of the test is within the error limits given in Annex E. If the test method is non-specific, such as flame photometry for sodium and potassium salts of ethylenediaminetetraacetic acid, an identification test is recommended.

9.2 The volume of the liquid additive in the container must be determined gravimetrically, corrected for the relative density of the liquid.

10 Markings and labels

10.1 The label should not completely cover the vial.

10.2 Marking and label should remain attached to the container after exposure to air at a temperature of (4 ± 1) °C for at least 48 hours.

NOTE This subclause specifies requirements for a product under normal conditions. However, when the product is stored or used under extreme conditions (extreme temperature or humidity, or abnormal transportation, or long-term storage), the requirements may not be adequate. The manufacturer is responsible for ensuring that the product is suitable for storage or use under abnormal or abnormal conditions.

10.3 The marking on the outside of each primary packaging must contain the following information:

a) name and address of manufacturer and supplier;

b) lot number;

c) expiry date;

d) a description of the content, which should include:

- nominal capacity;

- coating (eg non-contact activation) or additives in all tubes;

- names of additives or their formulas and/or letter code given in Table 2;

Table 2 - Letter codes and recommended color codes for identifying additives


	Letter codes
EDTA dipotassium salt		pale lilac
tripotassium salt		pale lilac
disodium salt		pale lilac
Trisodium citrate 9:1		Pale blue color
Trisodium citrate 4:1		Black color
Fluoride/oxalate		Grey colour
Fluoride/EDTA		Grey colour
Fluoride/heparin		Green color
Lithium heparin		Green color
Sodium heparin		Green color
Citrate Phosphate Dextrose Adenine		Yellow
Nothing		Red color
EDTA is the practical abbreviation for ethylenediaminetetraacetic acid, instead of the correct systematic name, i.e. (ethylenediaminetetraacetic acid). The ratio between the desired volumes of blood and liquid anticoagulant is noted (eg, 9 volumes of blood to one volume of citrate solution).

- the inscription "sterile", if the manufacturer guarantees that the interior of the unopened container and its contents are sterile;

- the inscription "one-time" or a graphic symbol in accordance with ISO 7000;

- storage requirements.

10.4 If the container is specifically for testing a particular substance, the maximum contamination level for that substance should be indicated on the label or on the primary packaging.

10.5 Containers shall bear the following information, either directly on the tube or on a label:

a) name or trademark of the manufacturer or supplier;

b) lot number;

c) letter code (see Table 2) and/or description of contents;

d) expiration date;

e) nominal capacity;

f) filling line, if necessary, eg for non-vacuum containers;

g) the inscription "sterile" if the manufacturer guarantees that the interior of the unopened and unused container and its contents are sterile.

If glycerin has been used in the manufacture of the container, this must be indicated on the label or on the packaging.

11 Container identification

Containers must be identified by the letter code and/or additive description given in Table 2. If additives other than those listed in Table 2 are used, containers must be identified by the additive description.

NOTE 1 There is currently no international agreement on color coding.

NOTE 2 When color coding is used, the codes shown in Table 2 are recommended.

NOTE 3—When color coding is used, it is recommended that the color of the stopper match the color of the tube or label.

Annex A (mandatory). Nominal capacity and minimum free space tests for non-vacuum containers

Annex A
(mandatory)

A.1 Reagents and equipment

A.1.1 Water, in accordance with ISO 3696, at 20 °C to 25 °C.

A.1.2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accuracy to ± 0.1 ml), with a tip at the bottom or side.

A.2 Test conditions

A.2.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

A.2.2 Unused containers should be tested.

A.3 Test procedure

A.3.1 Close the tip of the burette and fill it with water.

A.3.2 Place an open container under the outlet cock of the burette and carefully pour water into the container until the meniscus reaches the level of the filling line, then close the cock.

A.3.3 Record the volume of water dispensed from the burette.

A.3.4 Continue pouring water from the burette until the water level reaches the neck of the test tube, and note the volume of water released to the nearest ± 0,1 ml.

A.4 Test criteria

A.4.1 The container shall pass the nominal capacity test if the volume of water discharged from the burette corresponds to the nominal capacity ±10%.

A.4.2 The container shall pass the minimum headspace test if, assuming that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than that indicated in Table 1 for containers of the type tested .

NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding part of the cork or the excess volume due to the concave shape of the cork.

Annex B (mandatory). Retracted (sucked) volume and minimum free space tests for vacuum containers

Annex B
(mandatory)

B.1 Reagents and equipment

B.1.1 Water, in accordance with ISO 3696, at 20 °C to 25 °C.

B.1.2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accurate to ± 0.1 ml), with tip at the bottom or side.

B.1.3 Clear silicone rubber tube (short).

B.1.4 Blood collection needles as recommended by the container manufacturer.

B.2 Tests for retracted (sucked in) volume

B.2.1 Test conditions

B.2.1.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

B.2.1.2 Unused containers should be tested.

B.2.2 Test procedure

B.2.2.1 Assemble the product, if supplied unassembled, insert the needle into the holder in accordance with the container manufacturer's instructions.

B.2.2.2 Fill the burette with water, open the burette cock and let the water through the silicone rubber filling clamp; leave the burette empty.

B.2.2.3 Insert the external needle of the blood collection needle/needle holder assembly through the wall of the silicone tubing until the needle enters the lumen of the tubing.

B.2.2.4 Connect the container to the needle/holder assembly in accordance with the container manufacturer's instructions.

B.2.2.5 Fill the container for at least one minute, or as directed by the manufacturer.

B.2.3 Test criteria

The container may pass the test if the volume of water drawn in is ±10% nominal capacity.

B.3 Minimum clearance test

B.3.1 Test conditions

B.3.1.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

B.3.1.2 Unused containers should be tested.

B.3.2 Test procedure

B.3.2.1 Remove the silicone tube from the burette outlet valve with the valve closed and fill the burette with water if necessary.

B.3.2.2 Place the open tube under the burette outlet valve.

B.3.2.3 Pour water until the water level reaches the neck of the tube.

B.3.2.4 Record the volume of water released to the nearest ±0,1 ml.

B.3.2.5 Determine the minimum headspace by subtracting the volume of water drawn in during the draw-in volume test (see B.2) from the total volume of water discharged from the burette.

B.3.3 Test criteria

The container is considered to have passed the test if, assuming that the free space available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than indicated in Table 1 for containers of the type tested.

NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding portion of the cork or the excess volume due to the concave shape of the cork.

Annex C (mandatory). Container leak test

Appendix C
(mandatory)

C.1 Reagents

C.1.1 Solution prepared by dissolving 2.5 g of sodium fluorescein [uranine, CAS number 518-47-8] in 100 ml of 0.15 mol/l sodium chloride solution [; number CAS 7647-14-5] containing 60 g/l dextran 70 [CAS number 9004-54-0], or equivalent.
_______________
The CAS number means the Chemical Abstracts Service Registry number.

C.1.2 Deionized water that does not fluoresce when viewed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected to normal vision without special instruments.

C.2 Equipment

C.2.1 Reservoir (for sodium fluorescein reagent) connected to a plastic tube of sufficient length (1 m). When testing a vacuum container, the tubing should be connected to a blood collection needle as recommended by the manufacturer. When testing other containers, the tubing shall be connected to a hollow end of rigid material which terminates in a conical constriction bonded to a 6% Luer fitting conforming to ISO 594-1.

C.2.2 Long wavelength ultraviolet light source.

C.2.3 Roller-type mixer, or other mixer recommended by the container manufacturer.

C.2.4 Wrench (if necessary).

C.3 Test procedures for non-vacuum containers

C.3.1 Fill the reservoir with reagent (C.1.1).

C.3.2 Remove the stopper from the tube and fill it to the nominal capacity from the reservoir, avoiding contamination of the outer surface and edge of the tube with the reagent. Insert the plug as directed by the manufacturer. Tighten the screw cap to the torque specified by the manufacturer. Insert the cap firmly into place in the neck of the test tube. Insert the cover cap into place over the edges of the tube.

C.3.3 With normal or corrected to normal vision without magnification, examine the container in a darkened room to ensure that the surface is not contaminated with reagent. If necessary, wash off contamination with water and examine under ultraviolet light as above.

C.3.4 Roll the container on a roller mixer for 2 min or mix the contents as directed by the container manufacturer. Completely submerge the container in a vessel containing no more than 100 ml of water so that the water completely covers the cork. Leave the container in water at a temperature of 15°C to 20°C for 60 minutes. Remove the container from the water and examine the water under ultraviolet light as described in C.3.3.

C.4 Test procedure for vacuum containers

C.4.1 Fill the reservoir with reagent (C.1.1).

C.4.2 Fill the container to its nominal capacity from a reservoir connected to the blood collection needle, avoiding contamination of the outer surface of the container with the reagent. After filling the container, separate it from the needle and, having washed the outer part of the test tube and stopper from possible contamination by the reagent, examine it in ultraviolet light as described in C.3.3.

C.4.3 Carry out the procedures described in C.3.4.

C.5 Procedure for containers to be filled either by perforating the stopper or after removing the stopper

C.5.1 Fill the reservoir with reagent (C.1.1).

C.5.2 Fill as indicated below.

a) Filling by perforating the cork

Carefully insert the rigid tip of the tubing through the portion of the cork that is intended to be perforated and fill the container to its nominal capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, remove it from the hard tip and, having washed the tube and stopper from possible contamination by the reagent, examine the container in ultraviolet light, as indicated in C.3.3.

b) Filling after removing the stopper.

Use the method described in C.3.2 and C.3.3.

C.5.3 Follow the procedures described in C.3.4.

C.6 Test criteria

The container is deemed to have passed the test if no fluorescence is detected in the water.

Annex D (mandatory). Container strength test

Appendix D
(mandatory)

D.1 Reagents and equipment

D.1.1 Test fluid having the same relative density as normal human blood.

D.1.2 Blood sample container.

D.1.3 Centrifuge capable of subjecting the base of the container to a centrifugal acceleration of up to 3000 for 10 min.

D.2 Test procedure

D.2.1 Fill the container with the test liquid using the method specified by the manufacturer, removing the plug and replacing it if necessary.

D.2.2 Ensure that the container is correctly placed and balanced in the centrifuge.

D.2.3 Centrifuge the filled container by subjecting its base to a centrifugal acceleration of 3000 for 10 min, then carefully place it in the rack and inspect.

D.3 Test criteria

The container is considered to have passed the test if the container does not break, leak or crack.

Annex E (mandatory). Additive Concentrations and Liquid Additive Volume

Annex E
(mandatory)

E.1 Salts of ethylenediaminetetraacetic acid

CAS number 60-00-4

The concentrations of dipotassium salt [CAS number 25102-12-9], tripotassium salt [CAS number 17572-97-3], and disodium salt [CAS number 6381-92-6] should be between 1.2 and 2 mg anhydrous EDTA per 1 ml of blood [EDTA calculated as the anhydrous salt of the isolated acid (0.004 11 mol/l to 0.006 843 mol/l)]. Appropriate allowance must be made to compensate for the salt actually used for its water of crystallization.

E.2 Trisodium citrate CAS number 6132-04-34

E.2.1 Trisodium citrate concentrations should be between 0.1 and 0.136 mol/l solution. The allowable tolerance for the specific amount of additive should be ±10%.

E.2.2 For coagulation studies: 9 volumes of blood should be added to 1 volume of trisodium citrate solution.

E.2.3 Westergren's erythrocyte sedimentation rate: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.

E.3 Fluoride/oxalate

Concentrations should be between 1 and 3 mg potassium oxalate monohydrate [CAS number 6487-48-5] (0.0039334 mol/l to 0.001 1 mol/l) and between 2 and 4 mg sodium fluoride [CAS number 7681- 49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.

E.4 Fluoride/EDTA

Concentrations should be in the range of 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.

E.5 Fluoride/heparin

Concentrations should be in the range of 12 to 30 international units of heparin and 2 to 4 mg of fluoride per ml of blood.

E.6 Sodium/heparin[CAS number 9041-08-1] lithium/heparin[CAS number 9045-22-1]

Concentrations should be between 12 and 30 international units per ml of blood.

E.7 Citrate phosphate dextrose adenine (CPDA)

E.7.1 The formula shall be as follows:


Citric Acid (Anhydrous) [CAS No. 77-92-9]
Trisodium citrate (dihydrate) [CAS number 77-92-9]
Monobasic sodium phosphate CAS number 10049-21-5
Dextrose (monohydrate) [CAS number 5996-10-1]
Adenine [CAS number 73-24-5
Water for injection, enough to

E.7.2 Six volumes of blood should be added to one volume of CPDA solution.

E.7.3 The permitted tolerance to the specified amount of additive should be within ± 10%.

NOTE Additives can be presented in various physical forms, for example, as a solution, dry residue from a solution, evaporated by heating, lyophilized or in powder form. Concentration limits are allowed for the different solubility and diffusion rates of these different forms, especially for EDTA.

Bibliography


	Recommended methodology for using International Reference Preparations for Thromboplastin, 1983, World Health Organization, Geneva, Switzerland
	International Committee for Standardization in Haematology, 1977, Recommendation for measurement of erythrocyte sedimentation rate of human blood), American Journal of Clinical Pathology, 68, 1977, pp.505-507 erythrocyte sedimentation in human blood)
	Anticoagulant Citrate Phosphate Dextrose Adenine Solution, pp.101-102, The United States Pharmacopoeia, The National Formulary, USP XXII, NF XVII, 1990, United States Pharmacopoeial Convention, Inc., Rockville, MD, USA

Appendix YES (reference). Information on the compliance of interstate standards with reference international standards

Appendix YES
(reference)

Table YES.1


Designation and name of the reference international standard	Compliance degree	Designation and name of the interstate standard
ISO 594-1:1986 Conical fixtures with 6% (Luer) constriction for syringes, needles and some other equipment. Part 1. General requirements
ISO 3696:1987 Water for laboratory analysis. Technical requirements and test methods
ISO 7000:1989 Graphic symbols for application to equipment. Index and summary
* There is no corresponding interstate standard. Prior to its approval, it is recommended to use the Russian translation of this International Standard

Electronic text of the document
prepared by Kodeks JSC and verified against:
official publication
M.: Standartinform, 2013

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INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION

INTERSTATE

STANDARD

CONTAINERS FOR COLLECTION OF SAMPLES OF VENOUS BLOOD, DISPOSABLE

Technical requirements and test methods

(ISO 6710:1995, UT)

Official edition

GOST ISO 6710-2011

Standartinform

Foreword

The goals, basic principles and procedure for carrying out work on interstate standardization are established by GOST 1.0-92 “Interstate standardization system. Basic Provisions” and GOST 1.2-2009 “Interstate Standardization System. Interstate standards, rules and recommendations for interstate standardization. Rules for the development, adoption, application, updating and cancellation "

About the standard

1 PREPARED BY Federal State Unitary Enterprise "All-Russian Research Institute for Standardization and Certification in Mechanical Engineering" (VNIINMASH)

2 INTRODUCED by the Federal Agency for Technical Regulation and Metrology (Rosstan-

3 ADOPTED by the Interstate Council for Standardization, Metrology and Certification (Minutes of November 29, 2011 No. 40)

4 By order of the Federal Agency for Technical Regulation and Metrology dated December 13, 2011 No. 1379-st, the interstate standard GOST ISO 6710-2011 was put into effect as the national standard of the Russian Federation from January 1, 2013.

5 This International Standard is identical to ISO 6710:1995 Single-use containers for venous blood specimen collection.

The degree of conformity is identical (YUT).

The standard has been prepared based on the application of GOST R ISO 6710-2009

Information on the compliance of interstate standards with reference international standards is given in the additional appendix YES

6 INTRODUCED FOR THE FIRST TIME

Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information index "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet

In the Russian Federation, this standard cannot be fully or partially reproduced, replicated and distributed as an official publication without the permission of the Federal Agency for Technical Regulation and Metrology

Annex C (mandatory)

Container leak test

C.1 Reagents

C.1.1 Solution prepared by dissolving 2.5 g of sodium fluorescein [uranine, CAS number 518-47-8] a > in 100 ml of 0.15 mol/l sodium chloride solution containing 60 g/l of dextran 70 [number CAS 9004-54-0], or equivalent.

C.1.2 Deionized water that does not fluoresce when viewed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected to normal vision without special instruments.

C.2 Equipment

C.2.1 Reservoir (for sodium fluorescein reagent) connected to a plastic tube of sufficient length (1 m). When testing a vacuum container, the tubing should be connected to a blood collection needle as recommended by the manufacturer. When testing other containers, the tubing shall be connected to a hollow tip of rigid material which terminates in a conical constriction bonded to a 6 % Luer fitting conforming to ISO 594-1.

C.2.2 Long wavelength ultraviolet light source.

C.2.3 Roller-type mixer, or other mixer recommended by the container manufacturer.

C.2.4 Wrench (if necessary).

C.3 Test procedures for non-vacuum containers

C.3.1 Fill the reservoir with reagent (C.1.1).

C.4 Test procedure for vacuum containers

C.4.1 Fill the reservoir with reagent (C.1.1).

C.4.3 Carry out the procedures described in C.3.4.

C.5 Procedure for containers intended to be filled or perforated

or after removing the cork

C.5.1 Fill the reservoir with reagent (C.1.1).

C.5.2 Fill as indicated below.

a) Filling by perforating the cork

Carefully insert the rigid tip of the tubing through the portion of the stopper intended to be perforated and fill the container to its nominal capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, remove it from the hard tip and, having washed the tube and stopper from possible contamination by the reagent, examine the container in ultraviolet light, as indicated in C.3.3.

b) Filling after removing the stopper.

Use the method described in C.3.2 and C.3.3.

C.5.3 Follow the procedures described in C.3.4.

C.6 Test criteria

The container is deemed to have passed the test if no fluorescence is detected in the water.

a) CAS Number means Chemical Abstracts Service Registry number.

GOST ISO 6710-2011

Annex D (mandatory)

Container strength test

D.1 Reagents and equipment

D.1.1 Test fluid having the same relative density as normal human

D.1.2 Blood sample container.

D.1.3 Centrifuge capable of subjecting the base of the container to centrifugal acceleration up to 3000 for 10 min.

D.2 Test procedure

D.2.1 Fill the container with the test liquid using the method specified by the manufacturer, removing the plug and replacing it if necessary.

D.2.2 Ensure that the container is correctly placed and balanced in the centrifuge.

D.2.3 Centrifuge the filled container by subjecting the base to 3000 centrifugal acceleration for 10 min, then carefully place it in the rack and inspect.

D.3 Test criteria

The container is considered to have passed the test if the container does not break, leak or crack.

Annex E (mandatory)

Additive Concentrations and Liquid Additive Volume

E.1 Salts of ethylenediaminetetraacetic acid

[(EDTA) ((CH2N(CH 2 COOH 2) 2 ] 2 ; CAS number 60-00-4)]

E.2 Trisodium citrate

E.2.1 Trisodium citrate concentrations should be between 0.1 and 0.136 mol/l of solution. The allowed tolerance for the specific amount of additive should be ± 10%.

E.2.2 For coagulation studies: 9 volumes of blood should be added to 1 volume of trisodium citrate solution.

E.2.3 Westergren's erythrocyte sedimentation rate: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.

E.3 Fluoride/oxalate

Concentrations should be between 1 and 3 mg potassium oxalate monohydrate [CAS number 6487-48-5] (0.0039334 mol/l to 0.001 1 mol/l) and between 2 and 4 mg sodium fluoride [CAS number 7681- 49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.

E.4 Fluoride/EDTA

Concentrations should be in the range of 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.

E.5 Fluoride/heparin

Concentrations should be in the range of 12 to 30 international units of heparin and 2 to 4 mg of fluoride per ml of blood.

E.6 Sodium/heparin [CAS number 9041-08-1] Lithium/heparin [CAS number 9045-22-1]

Concentrations should be between 12 and 30 international units per ml of blood.

E.7 Citrate phosphate dextrose adenine (CPDA)

E.7.1 The formula shall be as follows:

Citric Acid (Anhydrous) [CAS No. 77-92-9].................................2.99 g

Trisodium citrate (dihydrate) [CAS number 77-92-9].................................26.3 g

Monobasic sodium phosphate .................................. 2.22 g

Dextrose (monohydrate) [CAS number 5996-10-1] .....................31.9 g

Adenine ............................ 0.275 g

Water for injection, enough up to ...................... 1000 ml.

E.7.2 Six volumes of blood should be added to one volume of CPDA solution.

E.7.3 The permitted tolerance to the specified amount of additive should be within ± 10%.

Notes e-Additives can be presented in various physical forms, for example, as a solution, solids from a solution evaporated by heating, lyophilized or in powder form. Concentration limits are allowed for the different solubility and diffusion rates of these different forms, especially for EDTA.

GOST ISO 6710-2011

Bibliography

Recommended methodology for using International Reference Preparations for Thromboplastin, 1983, World Health Organization, Geneva, Switzerland

International Committee for Standardization in Haematology, 1977, Recommendation for measurement of erythrocyte sedimentation rate of human blood), American Journal of Clinical Pathology, 68, 1977, pp. 505-507 (International Committee for Standardization in Hematology. 1977, Recommendations for the measurement of erythrocyte sedimentation rate in human blood)

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, United States Pharmacopoeia National Formularies, 1990, pp. 101-102) Anticoagulant Citrate Phosphate Dextrose Adenine Solution, pp. 101-102, The United States Pharmacopoeia, The National Formulary, USP XXII, NF XVII, 1990, United States Pharmacopoeial Convention, Inc., Rockville, MD, USA

Appendix YES (reference)

Information on the compliance of interstate standards with reference international standards

Table YES. 1

Designation and name of the reference international standard	compliance	Designation and name of the interstate standard
ISO 594-1:1986 6% (Luer) conical conical devices for syringes, needles and certain other equipment. Part 1. General requirements
ISO 3696:1987 Water for laboratory analysis. Technical requirements and test methods
ISO 7000:1989 Graphic symbols for application to equipment. Index and summary
* There is no corresponding interstate standard. Prior to its approval, it is recommended to use the Russian translation of this International Standard

UDC 615.38.014.8:006.354 MKS 11.040.20 YUT

Keywords: disposable venous blood collection containers, container testing, additives, labeling

Editor D.M. Kulchitsky Technical editor V.N. Prusakova Proofreader M.S. Kabashova Computer layout L.A. Circular

Handed over to the set 08/30/2013. Signed for publication on September 19, 2013. Format 60/84X - Headset Ariap. Uel. oven l. 1.86. Uch.-ed. l. 1.35. Circulation 58 copies. Zach. 1029.

FSUE STANDARTINFORM, 123995 Moscow, Granatny per., 4. www.gostinfo.ru [email protected]

Typed in FSUE "STANDARTINFORM" on a PC.

Printed in the branch of FSUE "STANDARTINFORM" - type. "Moscow printer", 105062 Moscow, Lyalin per., 6.

1 Scope ...............................................................1

3 Terms and definitions...............................................1

4 Materials.............................................. .2

5 Capacity................................................... 2

6 Device................................................... .3

7 Construction .................................................. .3

8 Sterility .............................................................. 3

9 Additives.............................................. ...3

10 Markings and labels...............................................3

11 Container identification....................................................4

Annex A (normative) Nominal capacity and minimum free space tests for non-vacuum containers ..............................................................6

Appendix B (normative) Retractable (suction) volume and minimum

free space for vacuum containers .................................7

Annex C (normative) Container Leak Test .................................................. 8

Annex D (normative) Container strength test ..................................................9

Annex E (normative) Additive concentrations and volume of liquid additive .............................. 10

Bibliography..............................................11

Annex YES (informative) Information on the compliance of interstate standards with reference international standards .................................................................. 11

INTERSTATE STANDARD

SINGLE USE VENOUS BLOOD SPECIMEN COLLECTION CONTAINERS Specifications and test methods

Single-use containers for venous blood specimen collection. Technical requirements and test methods

Introduction date -2013-01-01

1 area of use

NOTE This International Standard replaces the requirements for non-vacuum containers previously specified by ISO 4822 Disposable Blood Sample Collection Containers up to 25 ml, which has been withdrawn.

2 Normative references

ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements Part 1. General requirements)

ISO 3696:1987 Water for analytical laboratory use - Specification and test methods

ISO 7000:1989* Graphical symbols for use on equipment - Index and synopsis

3 Terms and definitions

In this standard, the following terms are used with their respective definitions:

3.1 container

3.2 evacuated container container designed to draw blood by means of a vacuum created by the manufacturer (i.e. pre-vacuum container) or by the user prior to drawing blood

3.3 tube

3.4 closure

3.5 primary pack direct packaging of containers

3.6 container interior inner surface of a container

3.7 additive

3.8 nominal capacity volume of whole blood with which the container is intended to be filled

3.9 free space excess capacity or head space that is created to ensure adequate mixing of the contents of a container as determined by the minimum free space tests given in Annexes A and B

Official edition

3.10 fill line line marked on the vial and on its label to indicate the nominal capacity of the container

3.11 draw volume nominal capacity of the vacuum container

3.12 expire date date after which the manufacturer cannot guarantee the conformity of the container with the requirements of this standard

3.13 closing torque torque, specified by the manufacturer, required to close a stopper tightly with a wrench to seal a container tightly

3.14 visual inspection inspection by an observer with normal or normal corrected vision in uniform illumination between 300 and 750 lux

4 Materials

4.1 The tube must be made of a material that allows the contents of the container to be clearly seen by visual inspection.

In the case of using a sample for the study of certain metals and other well-defined substances, the formula of the composition of the plug material should be such that there is no interference that affects the results.

NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may not be an agreed interference limit. In such cases, the user is advised to consult the manufacturer.

NOTE It is the responsibility of the manufacturer to validate the process. This International Standard does not specify a validation procedure, but a related standard is under development.

4.4 The container must be free from foreign objects during visual inspection.

5 Capacity

5.1 When tested according to the methods given in Annexes A and B, the volume of water added or drawn from the burette shall be within + 10% of the nominal capacity.

6 Device

6.1 The closure of the container shall not be compromised by mixing during the leak test in accordance with the methods specified in Annex C.

NOTE Some devices, such as blood cell counters, are designed to be able to aspirate the contents of a blood sample container without removing the stopper.

6.3 When testing a container for leakage in accordance with the method specified in Annex C, no fluorescence of the water in which the container is immersed shall be observed.

7 Design

7.1 When tested in accordance with the method specified in Annex D, the sample container shall withstand an acceleration of up to 3 000 g in the longitudinal axis during centrifugation.

Note - g n \u003d 9.80665 m / s 2.

7.2 Visual inspection of the container shall show no sharp edges or rough surface capable of inadvertently cutting, pricking or abrading the user's skin.

8 Sterility

NOTE It is the manufacturer's responsibility to verify the effectiveness of the process. This International Standard does not specify a verification process procedure, but a standard for control methods and sterilization confirmation processes is being developed. In the absence of national regulation, refer to the current European Pharmacopoeia, the current USP or the current British Pharmacopoeia.

8.2 Sterility is required when blood is drawn in direct contact between the inside of the container and the patient's bloodstream.

9 Additives

9.1 The specified nominal amount of additive should be within the limits specified in Annex E.

NOTE With one exception (see 9.2), test methods are not specified.

In the presence of sodium, potassium or lithium in the additive, it is recommended to use flame photometry. It is important that the accuracy of the test is within the error limits given in Annex E. If the test method is non-specific, such as flame photometry for sodium and potassium salts of ethylenediaminetetraacetic acid, an identification test is recommended.

9.2 The volume of the liquid additive in the container must be determined gravimetrically, corrected for the relative density of the liquid.

10 Markings and labels

10.1 The label should not completely cover the vial.

10.2 Marking and label must remain attached to the container after exposure to air at a temperature of (4 ± 1) °C for at least 48 hours.

NOTE This subclause specifies requirements for a product under normal conditions. However, when the product is stored or used under extreme conditions (extreme temperature or humidity, or abnormal transportation or long-term storage), the requirements may not be adequate. The manufacturer is responsible for ensuring that the product is suitable for storage or use under abnormal or abnormal conditions.

10.3 The marking on the outside of each primary packaging must contain the following information:

a) name and address of manufacturer and supplier;

b) lot number;

c) expiry date;

d) a description of the content, which should include:

Rated capacity;

Coating (eg non-contact activation) or additives in all tubes;

Names of additives or their formulas and/or letter code given in Table 2;

The inscription "sterile" if the manufacturer guarantees that the interior of the unopened container and its contents are sterile;

The inscription "one-time" or a graphic symbol in accordance with ISO 7000;

storage requirements.

10.4 If the container is specifically for testing a particular substance, the maximum contamination level for that substance should be indicated on the label or on the primary packaging.

10.5 Containers shall bear the following information, either directly on the tube or on a label:

a) name or trademark of the manufacturer or supplier;

b) lot number;

c) letter code (see Table 2) and/or description of contents;

d) expiration date;

e) nominal capacity;

f) filling line, if necessary, eg for non-vacuum containers;

e) the inscription "sterile", if the manufacturer guarantees that the interior of the unopened and unused container and its contents are sterile.

If glycerin has been used in the manufacture of the container, this must be indicated on the label or on the packaging.

11 Container identification

NOTE 1 There is currently no international agreement on color coding.

NOTE 2 When color coding is used, the codes shown in Table 2 are recommended.

NOTE 3—When color coding is used, it is recommended that the color of the stopper match the color of the tube or label.

End of table 2

	Letter codes
Fluoride/oxalate		Grey colour
Fluoride/EDTA		Grey colour
Fluoride/heparin		Green color
Lithium heparin		Green color
Sodium heparin		Green color
Citrate Phosphate Dextrose Adenine		Yellow
Nothing since >		Red color
a > EDTA is the practical abbreviation for ethylenediaminetetraacetic acid,
instead of the correct systematic name, i.e. (ethylenenitrilo)acetic acid.
b > The ratio between desired blood volumes and 9 blood volumes to one volume of citrate solution is noted.		liquid anticoagulant (eg.

Annex A (mandatory)

Nominal capacity and minimum free space tests

for non-vacuum containers

A.1 Reagents and equipment

A.1.1 Water, in accordance with ISO 3696, at a temperature of 20 °C-25 °C.

A.1.2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accurate to ± 0.1 ml), with a tip at the bottom or side.

A.2 Test conditions

A.2.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

A.2.2 Unused containers should be tested.

A.3 Test procedure

A.3.1 Close the tip of the burette and fill it with water.

A.3.2 Place an open container under the outlet cock of the burette and carefully pour water into the container until the meniscus reaches the level of the filling line, then close the cock.

A.3.3 Record the volume of water dispensed from the burette.

A.3.4 Continue pouring water from the burette until the water level reaches the neck of the test tube and note the volume of water released to the nearest ± 0.1 ml.

A.4 Test criteria

A.4.1 The container shall pass the nominal capacity test if the volume of water discharged from the burette corresponds to the nominal capacity ± 10%.

NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding part of the cork or the excess volume due to the concave shape of the cork.

GOST ISO 6710-2011

Annex B (mandatory)

Retracted (sucked in) volume and minimum free space tests

for vacuum containers

B.1 Reagents and equipment

B.1.1 Water, in accordance with ISO 3696, at a temperature of 20 °C-25 °C.

B.1.2 Burette, 50 ml capacity, graduated in 0.1 ml divisions (accurate to ± 0.1 ml), with tip at the bottom or side.

B.1.3 Clear silicone rubber tube (short).

B.1.4 Blood collection needles as recommended by the container manufacturer.

B.2 Tests for retracted (sucked in) volume

B.2.1 Test conditions

B.2.1.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

B.2.1.2 Unused containers should be tested.

B.2.2 Test procedure

B.2.2.1 Assemble the product, if supplied unassembled, insert the needle into the holder in accordance with the container manufacturer's instructions.

B.2.2.2 Fill the burette with water, open the burette cock and let the water through the silicone rubber filling clamp; leave the burette empty.

B.2.2.3 Insert the external needle of the blood collection needle/needle holder assembly through the wall of the silicone tubing until the needle enters the lumen of the tubing.

B.2.2.4 Connect the container to the needle/holder assembly in accordance with the container manufacturer's instructions.

B.2.2.5 Fill the container for at least one minute, or as directed by the manufacturer.

B.2.3 Test criteria

The container can pass the test if the volume of water drawn in is ± 10% nominal capacity.

B.3 Minimum clearance test

B.3.1 Test conditions

B.3.1.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, corrections must be made.

B.3.1.2 Unused containers should be tested.

B.3.2 Test procedure

B.3.2.1 Remove the silicone tube from the burette outlet valve with the valve closed and fill the burette with water if necessary.

B.3.2.2 Place the open tube under the burette outlet valve.

B.3.2.3 Pour water until the water level reaches the neck of the tube.

B.3.2.4 Record the volume of water released to the nearest ± 0,1 ml.

Determine the minimum headspace by subtracting the volume of water drawn in during the volume draw test (see B.2) from the total volume of water drawn from the burette.

B.3.3 Test criteria

The container is considered to have passed the test if, assuming that the free space available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than indicated in Table 1 for containers of the type tested.

NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding portion of the cork or the excess volume due to the concave shape of the cork.

Put into effect by the Order of the Federal Agency for Technical Regulation and Metrology dated December 13, 2011 N 1379-st

Interstate standard GOST ISO-6710-2011

"CONTAINERS FOR COLLECTING SAMPLES OF VENOUS BLOOD, DISPOSABLE. TECHNICAL REQUIREMENTS AND TEST METHODS"

Single-use containers for venous blood specimen collection. Technical requirements and test methods

Introduced for the first time

1 area of use

2. Regulatory references

ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements Part 1. General requirements)

ISO 3696:1987 Water for analytical laboratory use - Specification and test methods

ISO 7000:1989* Graphical symbols for use on equipment - Index and synopsis

3. Terms and definitions

In this standard, the following terms are used with their respective definitions:

3.1. container a vessel for a blood sample sealed with a stopper.

3.2. vacuum container (evacuated container): A container designed to draw blood using a vacuum created by the manufacturer (i.e., a pre-vacuum container) or by the user prior to drawing blood.

3.3. tube: The portion of a container without a stopper that contains the sample.

3.4. closure: The part by which a container is closed.

3.5. primary pack (primary pack): Direct packaging of containers.

3.6. container interior: The inner surface of a container.

3.7. additive (additive): Any substance (not associated with the inner surface of the container) placed in the container to ensure the performance of the intended analysis.

3.8. nominal capacity volume of whole blood with which the container is intended to be filled.

3.9. free space excess capacity or head space that is created to ensure adequate mixing of the contents of a container as determined by the minimum free space tests given in Annexes A and B.

3.10. fill line: A line marked on a vial and on its label to indicate the nominal capacity of the container.

3.11. draw volume: Nominal capacity of the vacuum container.

3.12. expiration date: The date after which the manufacturer cannot guarantee that the container meets the requirements of this standard.

3.13. closure torque (closing torque): Torque, specified by the manufacturer, which is required to close the stopper tightly with a wrench to hermetically seal the container.

3.14. visual inspection inspection by an observer with normal or corrected to normal vision in uniform illumination between 300 and 750 lux.

4. Materials

4.1. The tube must be made of a material that allows the contents of the container to be clearly seen by visual inspection.

4.2. If a container is specifically designed to test a particular substance, the maximum level of contamination of the inside of the container with that substance and the analytical method used must be specified by the manufacturer in the information provided, on the label or on the packaging (see also 10.4).

4.3. Containers containing microorganism-preserving additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to prevent microbial contamination of the additive and the interior of the container.

NOTE It is the responsibility of the manufacturer to validate the process. This International Standard does not specify a validation procedure, but a related standard is under development.

4.4. The container must be free from foreign objects during visual inspection.

5. Capacity

5.1. When tested in accordance with the methods given in Annexes A and B, the volume of water added to or drawn from the burette shall be within ±10% of the rated capacity.

5.2. In order to carry out the tests in accordance with the methods given in Annexes A and B, containers of additives shall be provided with sufficient free space to ensure adequate mixing by mechanical and manual means. The minimum headspace to allow adequate mixing should be as given in Table 1. It must be assumed that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid.

Table 1 - Values for the minimum free space to allow adequate mixing

6. Device

6.1. The stopper tightness of the container shall not be compromised by mixing during the leak test in accordance with the methods specified in Annex C.

6.2. When the cork is removed to gain access to the contents of the container, it must be possible to remove it with the fingers or mechanically so that the part of the cork contaminated with the contents of the container does not come into contact with the fingers.

NOTE Some devices, such as blood cell counters, are designed to be able to aspirate the contents of a blood sample container without removing the stopper.

6.3. When a container is tested for leakage in accordance with the method specified in Annex C, no fluorescence of the water in which the container is immersed shall be observed.

7. Construction

7.1. When tested in accordance with the method specified in Annex D, the sample container shall withstand an acceleration of up to 3000 g in the longitudinal axis during centrifugation.

Note - g n \u003d 9, 80665 m / s 2.

7.2. Visual inspection of the container shall show no sharp edges or rough surface capable of accidentally cutting, pricking or abrading the user's skin.

8. Sterility

8.1. If the manufacturer guarantees that the product is sterile, the interior of the container and any of its contents must be subjected to a verification process designed to confirm that the interior of an unopened and unused container and any of its contents are sterile.

8.2. Sterility is required when blood is drawn in direct contact between the inside of the container and the patient's bloodstream.

9 Additives

9.1. The specified nominal amount of additive shall be within the limits specified in Annex E.

NOTE With one exception (see 9.2), test methods are not specified.

9.2. The volume of the liquid additive in the container must be determined gravimetrically, corrected for the relative density of the liquid.

10 Markings and labels

10.1. The label must not completely cover the vial.

10.2. Marking and label must remain attached to the container after exposure to air at a temperature of (4 ± 1) ° C for at least 48 hours.

10.3. The label on the outside of each primary packaging must contain the following information:

a) name and address of manufacturer and supplier;

b) lot number;

c) expiry date;

d) a description of the content, which should include:

Rated capacity;

Coating (eg non-contact activation) or additives in all tubes;

Names of additives or their formulas and/or letter code given in Table 2;

The inscription "sterile" if the manufacturer guarantees that the interior of the unopened container and its contents are sterile;

The inscription "one-time" or a graphic symbol in accordance with ISO 7000;

storage requirements.

10.4. If the container is specifically designed for the study of a particular substance, the maximum contamination level for that substance must be indicated on the label or on the primary packaging.

10.5. Containers should have the following information printed directly on the vial or on the label:

a) name or trademark of the manufacturer or supplier;

b) lot number;

c) letter code (see Table 2) and/or description of contents;

d) expiration date;

e) nominal capacity;

f) filling line, if necessary, eg for non-vacuum containers;

g) the inscription "sterile" if the manufacturer guarantees that the interior of the unopened and unused container and its contents are sterile.

If glycerin has been used in the manufacture of the container, this must be indicated on the label or on the packaging.

11. Container identification

NOTE 1 There is currently no international agreement on color coding.

NOTE 2 When color coding is used, the codes shown in Table 2 are recommended.

NOTE 3—When color coding is used, it is recommended that the color of the stopper match the color of the tube or label.


EDTA*(a) dipotassium salt		pale lilac
tripotassium salt		pale lilac
disodium salt		pale lilac
Trisodium citrate 9:1*(b)		Pale blue color
Trisodium citrate 4:1*(b)		Black color
Fluoride/oxalate		Grey colour
Fluoride/EDTA		Grey colour
Fluoride/heparin		Green color
Lithium heparin		Green color
Sodium heparin		Green color
Citrate Phosphate Dextrose Adenine		Yellow
Nothing*(c)		Red color
(a) EDTA is the practical abbreviation for ethylenediaminetetraacetic acid, instead of the correct systematic name, i.e. (ethylenediaminetetraacetic acid). (b) The ratio between the desired volumes of blood and liquid anticoagulant is noted (eg, 9 volumes of blood to one volume of citrate solution).

Annex A
(mandatory)

Nominal capacity and minimum free space tests for non-vacuum containers

A.1. Reagents and equipment

A.1.1. Water, according to ISO 3696, temperature 20°C - 25°C.

A.1.2. Burette with a capacity of 50 ml, graduated in divisions of 0.1 ml (accuracy to ± 0.1 ml), with a tip at the bottom or on the side.

A.2. Test conditions

A.2.1 The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, corrections must be made.

A.2.2 Unused containers should be tested.

A.3 Test procedure

A.3.1. Close the tip of the burette and fill it with water.

A.3.2. Place an open container under the burette outlet tap and carefully pour water into the container until the water meniscus reaches the level of the fill line, then close the tap.

A.3.3. Record the volume of water released from the burette.

A.3.4. Continue pouring water from the buret until the water level reaches the neck of the test tube, and note the volume of water released to the nearest ±0.1 ml.

A.4 Test criteria

A.4.1. The container must pass the nominal capacity test if the volume of water discharged from the burette corresponds to the nominal capacity ±10%.

A.4.2. The container shall pass the minimum headspace test if, assuming that the headspace available for mixing the contents of the container is limited by the bottom surface of the stopper and the meniscus of the liquid, such a space is not less than that indicated in Table 1 for containers of the type tested.

Annex B
(mandatory)

Retracted (sucked) volume and minimum free space tests for vacuum containers

IN 1. Reagents and equipment

B.1.1. Water, according to ISO 3696, temperature 20°C - 25°C.

B.1.2. Burette with a capacity of 50 ml, graduated in divisions of 0.1 ml (accuracy to ± 0.1 ml), with a tip at the bottom or on the side.

B.1.3. Pure silicone rubber tube (short).

B.1.4. Blood collection needles as recommended by container manufacturer.

AT 2. Retracted (sucked in) volume tests

B.2.1. Test conditions

B.2.1.1. The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, corrections must be made.

B.2.1.2. Unused containers should be tested.

B.2.2 Test procedure

B.2.2.1. Assemble the product, if supplied unassembled, insert the needle into the holder according to the container manufacturer's instructions.

B.2.2.2. Fill the burette with water, open the burette tap and let the water through the silicone rubber tube filling clamp; leave the burette empty.

B.2.2.3. Insert the external needle of the blood collection needle/needle holder assembly through the wall of the silicone tubing until the needle enters the lumen of the tubing.

B.2.2.4. Connect the container to the needle/holder assembly according to the container manufacturer's instructions.

B.2.2.5. Fill the container for at least one minute or as directed by the manufacturer.

B.2.3. Test criteria

The container may pass the test if the volume of water drawn in is ±10% nominal capacity.

AT 3. Minimum free space test

B.3.1. Test conditions

B.3.1.1. The tests shall be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, corrections must be made.

B.3.1.2. Unused containers should be tested.

B.3.2. Test procedure

B.3.2.1. With the stopcock closed, separate the silicone tubing from the burette outlet cock and fill the burette with water if necessary.

B.3.2.2. Place the open tube under the burette outlet valve.

B.3.2.3. Pour water until the water level reaches the neck of the test tube.

B.3.2.4. Record the volume of released water to the nearest ±0.1 ml.

Determine the minimum headspace by subtracting the volume of water drawn in during the volume draw test (see B.2) from the total volume of water drawn from the burette.

B.3.3. Test criteria

NOTE Stoppers vary in shape and, in particular, their blood-contact side may protrude from the neck of the tube, separate, or have a pronounced concave or convex profile. These shape features can affect the available headspace, which must be taken into account when interpreting the test results. If necessary, the influence of the cork geometry can be determined by measuring, for example, the length of the occluding portion of the cork or the excess volume due to the concave shape of the cork.

Appendix C
(mandatory)

Container leak test

C.1. Reagents

C.1.1. Solution prepared by dissolving 2.5 g of sodium fluorescein [uranine, CAS number 518-47-8]*(a) in 100 ml of 0.15 mol/l sodium chloride solution containing 60 g/l of dextran 70 [CAS number 9004-54-0], or equivalent.

C.1.2. Deionized water that does not fluoresce when viewed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected to normal vision without special instruments.

C.2. Equipment

C.2.1. Reservoir (for sodium fluorescein reagent) connected to a plastic tube of sufficient length (1 m). When testing a vacuum container, the tubing should be connected to a blood collection needle as recommended by the manufacturer. When testing other containers, the tubing shall be connected to a hollow end of rigid material which terminates in a conical constriction bonded to a 6% Luer fitting conforming to ISO 594-1.

C.2.2. Source of long-wave ultraviolet light.

C.2.3. Roller-type mixer or other mixer recommended by the container manufacturer.

C.2.4. Wrench (if necessary).

C.3. Test procedures for non-vacuum containers

C.3.1. Fill the reservoir with reagent (C.1.1).

C.3.2. Remove the stopper from the tube and fill it up to the nominal capacity from the reservoir, avoiding contamination of the outer surface and edge of the tube with the reagent. Insert the plug as directed by the manufacturer. Tighten the screw cap to the torque specified by the manufacturer. Insert the cap firmly into place in the neck of the test tube. Insert the cover cap into place over the edges of the tube.

C.3.3. With normal or corrected to normal vision without magnification, examine the container in a darkened room to ensure that its surface is not contaminated with reagent. If necessary, wash off contamination with water and examine under ultraviolet light as above.

C.3.4. Roll the container on a roller mixer for 2 minutes or mix the contents as directed by the container manufacturer. Completely submerge the container in a vessel containing no more than 100 ml of water so that the water completely covers the cork. Leave the container in water at a temperature of 15°C to 20°C for 60 minutes. Remove the container from the water and examine the water under ultraviolet light as described in C.3.3.

C.4. Test procedure for vacuum containers

C.4.1. Fill the reservoir with reagent (C.1.1).

C.4.2. Fill the container to its nominal capacity from a reservoir connected to the blood collection needle, avoiding contamination of the outer surface of the container with the reagent. After filling the container, separate it from the needle and, having washed the outer part of the test tube and stopper from possible contamination by the reagent, examine it in ultraviolet light as described in C.3.3.

C.4.3. Carry out the procedures described in C.3.4.

C.5. Procedure for containers intended to be filled either by perforating the cork or after removing the cork

C.5.1. Fill the reservoir with reagent (C.1.1).

C.5.2. Fill as indicated below.

a) Filling by perforating the cork

b) Filling after removing the stopper.

Use the method described in C.3.2 and C.3.3.

C.5.3. Follow the procedures described in C.3.4.

C.6. Test criteria

The container is deemed to have passed the test if no fluorescence is detected in the water.

──────────────────────────────

*(a) CAS number means Chemical Abstracts Service Registry number.

Appendix D
(mandatory)

Container strength test

D.1. Reagents and equipment

D.1.1. A test fluid that has the same relative density as normal human blood.

D.1.2. Blood sample container.

D.1.3. Centrifuge capable of subjecting the base of the container to centrifugal acceleration up to 3000g for 10 minutes.

D.2. Test procedure

D.2.1. Fill the container with test liquid using the method specified by the manufacturer, removing the plug and replacing it if necessary.

D.2.2. You need to make sure that the container is correctly placed and balanced in the centrifuge.

D.2.3. Centrifuge the filled container by subjecting its base to 3000g centrifugal acceleration for 10 min, then carefully place it in the rack and inspect.

D.3. Test criteria

The container is considered to have passed the test if the container does not break, leak or crack.

Annex E
(mandatory)

Additive Concentrations and Liquid Additive Volume

E.1. Salts of ethylenediaminetetraacetic acid

[(EDTA)((CH2N)(CH 2 COOH 2) 2 ] 2 ; CAS number 60-00-4)]

The concentrations of dipotassium salt [CAS number 25102-12-9], tripotassium salt [CAS number 17572-97-3], and disodium salt [CAS number 6381-92-6] should be between 1.2 and 2 mg anhydrous EDTA per 1 ml of blood [EDTA calculated as the anhydrous salt of the isolated acid (0.004 11 mol/L to 0.006 843 mol/L)]. Appropriate allowance must be made to compensate for the salt actually used for its water of crystallization.

E.2. Trisodium citrate

E.2.1. Trisodium citrate concentrations should be in the range of 0.1 to 0.136 mol/l solution. The allowable tolerance for the specific amount of additive should be ±10%.

E.2.2. For coagulation studies: 9 volumes of blood must be added to 1 volume of trisodium citrate solution.

E.2.3. Erythrocyte sedimentation rate according to the Westergren method: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.

E.3. Fluoride/oxalate

Concentrations should be between 1 and 3 mg potassium oxalate monohydrate [CAS number 6487-48-5] (0.0039334 mol/l to 0.001 1 mol/l) and 2 to 4 mg sodium fluoride [CAS number 7681-49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.

E.4. Fluoride/EDTA

Concentrations should be in the range of 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.

E.5. Fluoride/heparin

Concentrations should be in the range of 12 to 30 international units of heparin and 2 to 4 mg of fluoride per ml of blood.

E.6. Sodium/Heparin [CAS Number 9041-08-1] Lithium/Heparin [CAS Number 9045-22-1]

Concentrations should be between 12 and 30 international units per ml of blood.

E.7. Citrate Phosphate Dextrose Adenine (CPDA)

E.7.1. The formula should be:

Citric acid (anhydrous) [CAS number 77-92-9]. . . . . . 2.99g

Trisodium citrate (dihydrate) [CAS number 77-92-9] . . . . . . 26.3 g

Monobasic sodium phosphate. . . . . . . . . . . . . . . . . . . 2.22g

Dextrose (monohydrate) [CAS number 5996-10-1]. . . . . . . . 31.9 g

Adenine. . . . . . . . . . . . . 0.275 g

Water for injection, enough up to. . . . . . . . 1000 ml.

E.7.2. Six volumes of blood must be added to one volume of CPDA solution.

E.7.3. The permitted tolerance to the specified volume of the additive must be within ±10%.

NOTE Additives can be presented in various physical forms, for example, as a solution, dry residue from a solution, evaporated by heating, lyophilized or in powder form. Concentration limits are allowed for the different solubility and diffusion rates of these different forms, especially for EDTA.

Bibliography

	Recommended methodology for using International Reference Preparations for Thromboplastin, 1983, World Health Organization, Geneva, Switzerland
	International Committee for Standardization in Haematology, 1977, Recommendation for measurement of erythrocyte sedimentation rate of human blood), American Journal of Clinical Pathology, 68, 1977, pp. 505 - 507 (International Committee for Standardization in Hematology. 1977, Recommendations for the measurement of erythrocyte sedimentation rate in human blood)
	Anticoagulant Citrate Phosphate Dextrose Adenine Solution, United States Pharmacopoeia. National Formularies, 1990, pp. 101-102) Anticoagulant Citrate Phosphate Dextrose Adenine Solution, pp. 101 - 102, The United States Pharmacopoeia, The National Formulary, USP XXII, NF XVII, 1990, United States Pharmacopoeial Convention, Inc., Rockville, MD, USA

Appendix YES
(reference)

Information on the compliance of interstate standards with reference international standards

Table YES.1

Designation and name of the reference international standard	Compliance degree	Designation and name of the interstate standard
ISO 594-1:1986 Conical fixtures with 6% (Luer) constriction for syringes, needles and some other equipment. Part 1. General requirements
ISO 3696:1987 Water for laboratory analysis. Technical requirements and test methods
ISO 7000:1989 Graphic symbols for application to equipment. Index and summary
* There is no corresponding interstate standard. Prior to its approval, it is recommended to use the Russian translation of this International Standard

ISO 6710 cover color. Disposable venous blood collection containersSpecifications and test methods

GOST R ISO 6710-2009 Disposable containers for collecting venous blood samples. Technical requirements and test methods

1 area of ​​use

2 Normative references

3 Terms and definitions

4 Materials

5 Capacity

6 Device

7 Design

8 Sterility

9 Additives

10 Markings and labels

11 Container identification

Annex A (mandatory). Nominal capacity and minimum free space tests for non-vacuum containers

Annex B (mandatory). Retracted (sucked) volume and minimum free space tests for vacuum containers

Annex C (mandatory). Container leak test

Annex D (mandatory). Container strength test

Annex E (mandatory). Additive Concentrations and Liquid Additive Volume

Bibliography

Appendix YES (reference). Information on the compliance of interstate standards with reference international standards

CONTAINERS FOR COLLECTION OF SAMPLES OF VENOUS BLOOD, DISPOSABLE

Technical requirements and test methods

Foreword

Container leak test

GOST ISO 6710-2011

Container strength test

Additive Concentrations and Liquid Additive Volume

GOST ISO 6710-2011

Bibliography

Information on the compliance of interstate standards with reference international standards

1 area of ​​use

2 Normative references

3 Terms and definitions

4 Materials

5 Capacity

6 Device

7 Design

8 Sterility

9 Additives

10 Markings and labels

11 Container identification

Nominal capacity and minimum free space tests

for non-vacuum containers

GOST ISO 6710-2011

Retracted (sucked in) volume and minimum free space tests

for vacuum containers

1 area of ​​use

2. Regulatory references

3. Terms and definitions

4. Materials

5. Capacity

6. Device

7. Construction

8. Sterility

9 Additives

10 Markings and labels

11. Container identification

Nominal capacity and minimum free space tests for non-vacuum containers

A.1. Reagents and equipment

A.2. Test conditions

A.3 Test procedure

A.4 Test criteria

Retracted (sucked) volume and minimum free space tests for vacuum containers

IN 1. Reagents and equipment

AT 2. Retracted (sucked in) volume tests

B.2.1. Test conditions

B.2.2 Test procedure

B.2.3. Test criteria

AT 3. Minimum free space test

B.3.1. Test conditions

B.3.2. Test procedure

B.3.3. Test criteria

Container leak test

C.1. Reagents

C.2. Equipment

C.3. Test procedures for non-vacuum containers

C.4. Test procedure for vacuum containers

C.5. Procedure for containers intended to be filled either by perforating the cork or after removing the cork

C.6. Test criteria

Container strength test

1 area of use

1 area of use

1 area of use