GOST ISO 6710-2011
INTERSTATE STANDARD
DISPOSABLE CONTAINERS FOR COLLECTION OF VENOUS BLOOD SAMPLES
Technical requirements and test methods
Single-use containers for venous blood specimen collection. Technical requirements and test methods
ISS 11.040.20
Date of introduction 2013-01-01
Preface
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 development, adoption, application , updates and cancellations"
Standard information
1 PREPARED by the Federal State Unitary Enterprise "All-Russian Research Institute of 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 (protocol dated November 29, 2011 N 40)
The following voted for the adoption of the standard:
Short name of the country according to MK (ISO 3166) 004-97 | Abbreviated name of the national standardization body |
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Belarus | State Standard of the Republic of Belarus |
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Kazakhstan | Gosstandart of the Republic of Kazakhstan |
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Kyrgyzstan | Kyrgyzstandard |
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Russian Federation | Rosstandart |
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Uzbekistan | Uzstandard |
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Tajikistan | Tajikstandard |
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 a national standard Russian Federation from January 1, 2013
5 This standard is identical to the international standard ISO 6710:1995* Single-use containers for venous blood specimen collection.
________________
* Access to international and foreign documents mentioned here and further in the text can be obtained by following the link to the website http://shop.cntd.ru. - Database manufacturer's note.
Degree of compliance - identical (IDT).
The standard was 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 Additional Appendix DA
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 is published in the monthly published information index "National Standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notices and texts are also posted in information system for general use - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet
1 area of use
1 area of use
This 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 or needle holders.
NOTE This standard replaces the requirements for non-vacuum containers previously specified in ISO 4822, Disposable blood collection containers up to 25 ml, which has been cancelled.
2 Normative references
This standard refers to the following: international standards*:
____________
* For the table of correspondence between national standards and international ones, see the link. - 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 laboratory analysis. Technical requirements and test methods)
ISO 7000:1989* Graphical symbols for use on equipment - Index and synopsis summary)
_______________
* ISO 7000:2004 has been in force since February 19, 2004.
3 Terms and definitions
The following terms with corresponding definitions are used in this standard:
3.1 container(container): A container for a blood sample, sealed with a stopper.
3.2 vacuum container(evacuated container): A container designed to collect blood using a vacuum created by the manufacturer (i.e., pre-vacuum container) or by the user before blood collection.
3.3 test tube(tube): The portion of a container without a stopper that contains a sample.
3.4 cork closure: The part by which a container is sealed.
3.5 primary packaging(primary pack): Direct packing of containers.
3.6 container interior(container interior): The inner surface of a container.
3.7 additive(additive): Any substance (not associated with the interior surface of the container) placed in the container to enable the intended analysis to be performed.
3.8 nominal capacity(nominal capacity): The volume of whole blood that is expected to fill the container.
3.9 free space free space: The 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 filling line fill line: A line marked on a tube and its label to indicate the nominal capacity of the container.
3.11 suction volume(draw volume): The nominal capacity of a vacuum container.
3.12 best before date expire date: The date after which the manufacturer cannot guarantee that the container conforms to the requirements of this standard.
3.13 twist plugging Closing torque: The torque specified by the manufacturer that is required to tightly close a stopper using a wrench to seal a container tightly.
3.14 visual inspection(visual inspection): Inspection by an observer with normal or corrected normal level vision under uniform illumination from 300 to 750 lux.
4 Materials
4.1 The test tube must be made of a material that allows the contents of the container to be clearly visible upon visual inspection.
It is recommended that the inner surface of glass tubes intended for samples to be tested for blood coagulation studies should not cause contact activation (see).
4.2 If a container is specifically intended for the examination of a particular substance, the maximum level of contamination of the interior of the container with that substance and the analytical method used should be indicated 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 precisely defined substances, the formula for the composition of the stopper material must be such that no interference occurs that affects the results.
NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may be no agreed interference limit. In such cases, the consumer is advised to consult the manufacturer.
4.3 Containers containing microbial preservative additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to ensure that there is no microbial contamination of the additive or the interior of the container.
NOTE The manufacturer is responsible for process validation. This standard does not specify a confirmation procedure, but a standard is under development.
4.4 The container must be free of foreign objects upon visual inspection.
5 Capacity
5.1 When tested in accordance with the methods specified in Annexes A and B, the volume of water added or drawn from the burette shall be within ±10% of the rated capacity.
5.2 To conduct tests in accordance with the methods given in Annexes A and B, sufficient free space must be provided in containers containing additives to ensure adequate mixing by mechanical and manual methods. The minimum headspace to permit adequate mixing shall be as specified in Table 1. It shall be assumed that the available headspace for mixing the contents of the container is limited by the bottom surface of the stopper and the liquid meniscus.
Table 1 - Minimum free space values to allow adequate mixing
Nominal container capacity, ml | Minimum free space value |
>0.5 and<5,0 | 25% of rated capacity |
15% of rated capacity |
6 Device
6.1 The seal of the container shall not be compromised by mixing during the flow test in accordance with the methods specified in Annex C.
6.2 When the stopper is removed to gain access to the contents of the container, it must be possible to remove it with fingers or mechanically so that the part of the stopper contaminated with the contents of the container does not come into contact with your fingers.
NOTE Some instruments, such as blood cell counters, are designed to suck the contents of the blood sample container without removing the stopper.
6.3 When a container is leak tested in accordance with the method specified in Annex C, there shall be no fluorescence observed from the water in which the container is immersed.
7 Construction
7.1 When tested in accordance with the method specified in Annex D, the sample container, when centrifuged, must withstand an acceleration of up to 3000 along the longitudinal axis.
Note - = 9.80665 m/s.
7.2 Visual inspection of the container should not reveal any sharp edges or rough surfaces that could accidentally cut, prick or abrade the user's skin.
8 Sterility
8.1 If the manufacturer guarantees that the device is sterile, the inside of the container and any contents thereof shall be subjected to a testing process designed to confirm that the inside of the unopened and unused container and any contents thereof are sterile.
NOTE The manufacturer is responsible for confirming the effectiveness of the process. This standard does not specify a procedure for the verification process, but a standard for control methods and processes for confirming sterilization is being developed. In the absence of national regulations, reference should be made to the current European Pharmacopoeia, the current US Pharmacopoeia or the current British Pharmacopoeia.
8.2 Sterility is required when blood collection involves direct contact between the inside of the container and the patient's bloodstream.
9 Additives
9.1 The specified nominal amount of additive must be within the limits specified in Appendix E.
NOTE With one exception (see 9.2), test methods are not specified.
If sodium, potassium or lithium is present in the additive, flame photometry is recommended. It is important that the accuracy of the test meets the error limits specified 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 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 tube.
10.2 The 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 the requirements for the product under normal conditions. However, when the product is stored or used under extreme conditions (extremes of temperature or humidity, or abnormal transportation, or long-term storage), the requirements may be inadequate. The manufacturer is responsible for ensuring that the product is suitable for storage or use under extraordinary or other than normal conditions.
10.3 Labeling on the outside of each primary package must contain the following information:
a) name and address of the manufacturer and supplier;
b) lot number;
c) expiration date;
d) a description of the contents, 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 color |
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tripotassium salt | Pale lilac color |
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disodium salt | Pale lilac color |
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Trisodium citrate 9:1 | Pale blue color |
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Trisodium citrate 4:1 | Black color |
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Fluoride/oxalate | Grey colour |
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Fluoride/EDTA | Grey colour |
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Fluoride/heparin | Green color |
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Lithium heparin | Green color |
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Sodium heparin | Green color |
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Citrate phosphate dextrose adenine | Yellow |
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Nothing | Red color |
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EDTA is a practical abbreviation of the name ethylenediaminetetraacetic acid, instead of the correct systematic name, that is, (ethylenedinitrilo) acetic 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). |
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- the inscription “sterile” if the manufacturer guarantees that the inside of the unopened container and its contents are sterile;
- the inscription "disposable" or graphic symbol in accordance with ISO 7000;
- storage requirements.
10.4 If the container is intended 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 must have the following information printed directly on the tube or label:
a) name or trademark manufacturer or supplier;
b) lot number;
c) letter code (see Table 2) and/or content description;
d) expiration date;
e) nominal capacity;
f) filling line, if necessary, for example for non-vacuum containers;
g) the statement “sterile” if the manufacturer guarantees that the inside of the unopened and unused container and its contents are sterile.
If glycerin was used in the production of the container, this should be indicated on the label or packaging.
11 Container identification
Containers must be identified by the letter code and/or description of the additives given in Table 2. When using additives other than those listed in Table 2, containers must be identified by the description of the additive.
Note 1—There is currently no international agreement regarding color coding.
Note 2—When using color coding, the codes listed in Table 2 are recommended.
Note 3—When color coding is used, it is recommended that the color of the stopper matches the color of the tube or label.
Appendix A (mandatory). Tests for rated capacity and minimum free space for non-vacuum containers
Appendix A
(required)
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 with a capacity of 50 ml, graduated in 0.1 ml divisions (accuracy up 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 101 kPa atmospheric pressure and temperature environment 20 °C; when testing under other conditions, adjustments 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 valve and carefully release water into the container until the water meniscus reaches the level of the fill line, then close the valve.
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 released to the nearest ±0.1 ml.
A.4 Test criteria
A.4.1 The container shall pass the rated capacity test if the volume of water discharged from the burette corresponds to the rated capacity ±10%.
A.4.2 A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested. .
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
Appendix B (mandatory). Tests of suction volume and minimum free space for vacuum containers
Appendix B
(required)
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 with a capacity of 50 ml, graduated in 0.1 ml divisions (accurate to ±0.1 ml), with a tip at the bottom or side.
B.1.3 Clean silicone rubber tube (short).
B.1.4 Needles for blood collection in accordance with the recommendations of the container manufacturer.
B.2 Tests for retracted (sucked) volume
B.2.1 Test conditions
B.2.1.1 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, adjustments 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 it is supplied unassembled, insert the needle into the holder in accordance with the instructions of the container manufacturer.
B.2.2.2 Fill the burette with water, open the burette tap and let water flow through the filling clamp of the silicone rubber tube; leave the burette empty.
B.2.2.3 Insert the outer needle of the blood collection needle/needle holder complex through the wall of the silicone tube until the needle enters the lumen of the tube.
B.2.2.4 Connect the container to the needle/holder complex in accordance with the container manufacturer's instructions.
B.2.2.5 Fill the container for at least one minute or as specified by the manufacturer.
B.2.3 Test criteria
The container can pass the test if the volume of water drawn in is equal to the nominal capacity ±10%.
B.3 Minimum clearance tests
B.3.1 Test conditions
B.3.1.1 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, adjustments must be made.
B.3.1.2 Unused containers should be tested.
B.3.2 Test procedure
B.3.2.1 Separate 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 test tube under the outlet valve of the burette.
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.
B.3.2.5 Determine the minimum headspace by subtracting the volume of water drawn in during the drawn-in test (see B.2) from the total volume of water released from the burette.
B.3.3 Test criteria
A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested.
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
Appendix C (mandatory). Container leak testing
Appendix C
(required)
C.1 Reagents
C.1.1 A 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 [; CAS number 7647-14-5] containing 60 g/l dextran 70 [CAS number 9004-54-0], or equivalent.
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CAS number means Chemical Abstracts Service Registry number.
C.1.2 Deionized water that does not fluoresce when observed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected-to-normal vision without special equipment.
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 tube shall be connected to a hollow tip of rigid material which ends in a conical constriction secured to a 6% luer fitting conforming to ISO 594-1.
C.2.2 Source of long-wave ultraviolet light.
C.2.3 Roller 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 the reagent (C.1.1).
C.3.2 Remove the stopper from the test tube and fill it to the nominal capacity from the reservoir, avoiding contamination outer surface and the edges of the test tube with the reagent. Insert the plug as specified by the manufacturer. Tighten the screw cap to the torque specified by the manufacturer. Insert the cap into place tightly into the neck of the test tube. Place the cap into place over the edges of the tube.
C.3.3 With normal or corrected to normal vision without magnifying devices, examine the container in a darkened room to ensure that its surface is not contaminated with the reagent. If necessary, wash off contaminants with water and examine under ultraviolet light as indicated above.
C.3.4 Roll the container on a roller mixer for 2 minutes or mix its contents as directed by the container manufacturer. Completely immerse the container in a container containing no more than 100 ml of water until the water completely covers the stopper. 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 reagent. After filling the container, separate it from the needle and, having washed the outer part of the tube and stopper from possible contamination with the reagent, examine it under ultraviolet light as described in C.3.3.
C.4.3 Perform the procedures described in C.3.4.
C.5 Procedure for containers intended 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 plug
Carefully insert the rigid tip of the tube through the perforation portion of the stopper and fill the container to its rated capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, disconnect it from the hard tip and, having washed the test tube and stopper from possible contamination with the reagent, examine the container under ultraviolet light as indicated in C.3.3.
b) Filling after removing the plug.
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 considered to have passed the test if no fluorescence is detected in the water.
Appendix D (mandatory). Container strength tests
Appendix D
(required)
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 container base to a centrifugal acceleration of up to 3000 for 10 minutes.
D.2 Test procedure
D.2.1 Fill the container with test fluid using the method specified by the manufacturer, removing the stopper 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 3000 centrifugal acceleration for 10 minutes, then carefully place it in the rack and inspect it.
D.3 Test criteria
The container is considered to have passed the test if the container does not break, leak or crack.
Appendix E (mandatory). Additive concentrations and liquid additive volume
Appendix E
(required)
E.1 Salts of ethylenediaminetetraacetic acid
CAS number 60-00-4
Concentrations of dipotassium salt [CAS No. 25102-12-9], tripotassium salt [CAS No. 17572-97-3] and disodium salt [CAS No. 6381-92-6] should be in the range of 1.2 to 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 actual salt used for its water of crystallization.
E.2 Trisodium citrate CAS number 6132-04-34
E.2.1 Trisodium citrate concentrations should range from 0.1 to 0.136 mol/l solution. The permitted tolerance for the specific volume of the additive must be ±10%.
E.2.2 For blood coagulation studies: 9 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.2.3 Westergren erythrocyte sedimentation rate: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.3 Fluoride/oxalate
Concentrations should range from 1 to 3 mg potassium oxalate monohydrate [CAS No. 6487-48-5] (0.0039334 mol/L to 0.001 1 mol/L) and 2 to 4 mg sodium fluoride [CAS No. 7681- 49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.
E.4 Fluoride/EDTA
Concentrations should range from 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.
E.5 Fluoride/heparin
Concentrations should range from 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 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, sufficient quantity up 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 volume of the additive must be within ±10%.
NOTE Additives can be presented in various physical forms, for example, in the form of a solution, a solid residue from a solution, evaporated by heat, lyophilized or in powder form. Concentration limits are allowed for 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 (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 on standardization in hematology. 1977, Recommendations for the measurement of erythrocyte sedimentation rate in human blood) |
|
(Anticoagulant citrate phosphate dextrose adenine in solution. Pharmacopoeia of the United States of America. 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 (for reference). Information on the compliance of interstate standards with reference international standards
Application YES
(informative)
Table DA.1
Designation and name of the reference international standard | Degree of compliance | Designation and name of the interstate standard |
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 Graphic symbols for use on equipment. Index and summary | ||
* There is no corresponding interstate standard. Before its approval, it is recommended to use the Russian translation of this international standard. |
||
Electronic document text
prepared by Kodeks JSC and verified against:
official publication
M.: Standartinform, 2013
Put into effect by Order of the Federal Agency for Technical Regulation and Metrology dated December 13, 2011 N 1379-st
Interstate standard GOST ISO-6710-2011
"SINGLE-USE CONTAINERS FOR COLLECTION OF VENOUS BLOOD SAMPLES. 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
This 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 or needle holders.
NOTE This standard replaces the requirements for non-vacuum containers previously specified in ISO 4822, Disposable blood collection containers up to 25 ml, which has been cancelled.
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
The following terms with corresponding definitions are used in this standard:
3.1. container: A container for a blood sample, sealed with a stopper.
3.2. evacuated container: A container designed to collect blood using a vacuum created by the manufacturer (i.e., pre-vacuum container) or the user prior to blood collection.
3.3. tube: The part of a container without a stopper that contains a sample.
3.4. closure: The part that seals a container.
3.5. primary pack: Direct packaging of containers.
3.6. container interior: The inner surface of a container.
3.7. additive: Any substance (not bound to the inside of a container) placed in a container to enable the intended analysis to be performed.
3.8. nominal capacity: The volume of whole blood that is expected to fill the container.
3.9. free space: The 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 tube and its label to indicate the nominal capacity of the container.
3.11. draw volume: The nominal capacity of a vacuum container.
3.12. expiration date: The date after which the manufacturer cannot guarantee that the container conforms to the requirements of this standard.
3.13. Closing torque: The torque specified by the manufacturer that is required to tightly close a cap using a wrench to seal a container tightly.
3.14. visual inspection: Examination by an observer with normal or corrected-to-normal vision under uniform illumination between 300 and 750 lux.
4. Materials
4.1. The test tube must be made of a material that allows the contents of the container to be clearly visible upon visual inspection.
4.2. If a container is specifically intended for the study of a particular substance, the maximum level of contamination of the interior of the container with that substance and the analytical method used should be indicated 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 precisely defined substances, the formula for the composition of the stopper material must be such that no interference occurs that affects the results.
NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may be no agreed interference limit. In such cases, the consumer is advised to consult the manufacturer.
4.3. Containers containing microbial preservative additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to ensure that there is no microbial contamination of the additive or the interior of the container.
NOTE The manufacturer is responsible for process validation. This standard does not specify a confirmation procedure, but a standard is under development.
4.4. The container must be free of foreign objects upon visual inspection.
5. Capacity
5.1. When tested in accordance with the methods specified in Annexes A and B, the volume of water added or drawn from the burette shall be within ±10% of the rated capacity.
5.2. To conduct tests in accordance with the methods given in Annexes A and B, sufficient free space must be provided in additive containers to allow adequate mechanical and manual mixing. The minimum headspace to permit adequate mixing shall be as specified in Table 1. It shall be assumed that the available headspace for mixing the contents of the container is limited by the bottom surface of the stopper and the liquid meniscus.
Table 1 - Minimum free space values to allow adequate mixing
6. Device
6.1. The seal of the container shall not be compromised by mixing during the flow test in accordance with the methods specified in Annex C.
6.2. When the stopper is removed to gain access to the contents of the container, it must be possible to remove it with fingers or mechanically so that the part of the stopper contaminated by the contents of the container does not come into contact with the fingers.
NOTE Some instruments, such as blood cell counters, are designed to draw the contents of the blood sample container without removing the stopper.
6.3. When a container is leak tested according to the method specified in Annex C, there shall be no fluorescence observed from the water in which the container is immersed.
7. Design
7.1. When tested in accordance with the method specified in Annex D, the sample container must withstand an acceleration of up to 3 000 g in the longitudinal axis when centrifuged.
Note – g n =9, 80665 m/s 2 .
7.2. Visual inspection of the container should not reveal any sharp edges or rough surfaces that could accidentally cut, prick or abrade the user's skin.
8. Sterility
8.1. If the manufacturer guarantees that the device is sterile, the inside of the container and any contents thereof must be subjected to a testing process designed to confirm that the inside of the unopened and unused container and any contents thereof are sterile.
NOTE The manufacturer is responsible for confirming the effectiveness of the process. This standard does not specify a procedure for the verification process, but a standard for control methods and processes for confirming sterilization is being developed. In the absence of national regulations, reference should be made to the current European Pharmacopoeia, the current US Pharmacopoeia or the current British Pharmacopoeia.
8.2. Sterility is required when blood collection involves direct contact between the inside of the container and the patient's bloodstream.
9 Additives
9.1. The specified nominal amount of additive must be within the limits specified in Appendix E.
NOTE With one exception (see 9.2), test methods are not specified.
If sodium, potassium or lithium is present in the additive, flame photometry is recommended. It is important that the accuracy of the test meets the error limits specified 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 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 tube.
10.2. The 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 the requirements for the product under normal conditions. However, when the product is stored or used under extreme conditions (extremes of 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 extraordinary or other than normal conditions.
10.3. The labeling on the outside of each primary package must contain the following information:
a) name and address of the manufacturer and supplier;
b) lot number;
c) expiration date;
d) a description of the contents, 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 inside of the unopened container and its contents are sterile;
"Disposable" inscription or graphic symbol in accordance with ISO 7000;
Storage requirements.
10.4. If the container is intended specifically for testing a specific substance, the maximum contamination level for that substance should be indicated on the label or on the primary packaging.
10.5. Containers must have the following information printed directly on the tube or label:
a) name or trademark of the manufacturer or supplier;
b) lot number;
c) letter code (see Table 2) and/or content description;
d) expiration date;
e) nominal capacity;
f) filling line, if necessary, for example for non-vacuum containers;
g) the statement “sterile” if the manufacturer guarantees that the inside of the unopened and unused container and its contents are sterile.
If glycerin was used in the production of the container, this should be indicated on the label or packaging.
11. Container identification
Containers must be identified by the letter code and/or description of the additives given in Table 2. When using additives other than those listed in Table 2, containers must be identified by the description of the additive.
Note 1—There is currently no international agreement regarding color coding.
Note 2—When using color coding, the codes listed in Table 2 are recommended.
Note 3—When color coding is used, it is recommended that the color of the stopper matches the color of the tube or label.
|
EDTA*(a) dipotassium salt |
Pale lilac color |
|
|
tripotassium salt |
Pale lilac color |
|
|
disodium salt |
Pale lilac color |
|
|
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 a practical abbreviation of the name ethylenediaminetetraacetic acid, instead of the correct systematic name, that is, (ethylenedinitrilo) acetic 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). |
||
Appendix A
(required)
Tests for rated capacity and minimum free space 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 with a capacity of 50 ml, graduated in divisions of 0.1 ml (accuracy up to ±0.1 ml), with a tip at the bottom or side.
A.2. Test conditions
A.2.1 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, adjustments must be made.
A.2.2 Unused containers should be tested.
A.3 Test procedure
A.3.1. Close the burette tip and fill it with water.
A.3.2. Place an open container under the burette outlet valve and carefully release water into the container until the water meniscus reaches the level of the fill line, then close the valve.
A.3.3. Note 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 released to the nearest ±0.1 ml.
A.4 Test criteria
A.4.1. The container must pass the rated capacity test if the volume of water released from the burette meets the rated capacity ±10%.
A.4.2. A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested.
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
Appendix B
(required)
Tests of suction volume and minimum free space for vacuum containers
IN 1. Reagents and equipment
B.1.1. Water, in accordance with 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 up to ±0.1 ml), with a tip at the bottom or side.
B.1.3. Clean silicone rubber tube (short).
B.1.4. Blood collection needles as recommended by the container manufacturer.
AT 2. Tests for retracted (sucked) volume
B.2.1. Test conditions
B.2.1.1. Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, adjustments must be made.
B.2.1.2. Unused containers must be tested.
B.2.2 Test procedure
B.2.2.1. Assemble the product, if it is supplied unassembled, insert the needle into the holder in accordance with the instructions of the container manufacturer.
B.2.2.2. Fill the burette with water, open the burette tap and let the water flow through the filling clamp of the silicone rubber tube; leave the burette empty.
B.2.2.3. Insert the outer needle of the blood collection needle/needle holder complex through the wall of the silicone tube until the needle enters the lumen of the tube.
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 can pass the test if the volume of water drawn in is equal to the nominal capacity ±10%.
AT 3. Minimum Clearance Tests
B.3.1. Test conditions
B.3.1.1. Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20°C; when testing under other conditions, adjustments must be made.
B.3.1.2. Unused containers must be tested.
B.3.2. Test procedure
B.3.2.1. Separate the silicone tube from the burette outlet tap with the tap closed and fill the burette with water if necessary.
B.3.2.2. Place the open test tube under the outlet valve of the burette.
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 drawn-in test (see B.2) from the total volume of water released from the burette.
B.3.3. Test criteria
A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested.
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
Appendix C
(required)
Container leak testing
S.1. Reagents
C.1.1. A solution prepared by dissolving 2.5 g sodium fluorescein [uranine, CAS number 518-47-8]*(a) in 100 ml of 0.15 mol/l sodium chloride solution containing 60 g/l dextran 70 [CAS number 9004-54-0], or equivalent.
C.1.2. Deionized water that exhibits no fluorescence when observed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected-to-normal vision without special equipment.
C.2. Equipment
C.2.1. A 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 tube shall be connected to a hollow tip of rigid material which ends in a conical constriction secured to a 6% luer fitting conforming to ISO 594-1.
C.2.2. Source of long-wave ultraviolet light.
C.2.3. Roller mixer or other mixer recommended by the container manufacturer.
C.2.4. Wrench (if necessary).
S.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 test tube and fill it to the nominal capacity from the reservoir, being careful not to contaminate the outer surface and rim of the test tube with the reagent. Insert the plug as specified by the manufacturer. Tighten the screw cap to the torque specified by the manufacturer. Insert the cap into place tightly into the neck of the test tube. Place the 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 the reagent. If necessary, wash off contaminants with water and examine under ultraviolet light as indicated above.
C.3.4. Spin the container on a roller mixer for 2 minutes or mix its contents as directed by the container manufacturer. Completely immerse the container in a container containing no more than 100 ml of water until the water completely covers the stopper. 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 reagent. After filling the container, separate it from the needle and, having washed the outer part of the tube and stopper from possible contamination with the reagent, examine it under ultraviolet light as described in C.3.3.
C.4.3. Carry out the procedures described in C.3.4.
S.5. Procedure for containers intended 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 directed below.
a) Filling by perforating the plug
Carefully insert the rigid tip of the tube through the perforated portion of the stopper and fill the container to its rated capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, disconnect it from the hard tip and, having washed the test tube and stopper from possible contamination with the reagent, examine the container under ultraviolet light as indicated in C.3.3.
b) Filling after removing the plug.
Use the method described in C.3.2 and C.3.3.
C.5.3. Follow the procedures described in C.3.4.
S.6. Test criteria
The container is considered to have passed the test if no fluorescence is detected in the water.
──────────────────────────────
*(a) CAS number means Chemical Abstracts Service Registry number.
Appendix D
(required)
Container strength tests
D.1. Reagents and equipment
D.1.1. A test fluid that has the same relative density as normal human blood.
D.1.2. Container with blood sample.
D.1.3. A centrifuge capable of subjecting the container base to a centrifugal acceleration of up to 3000g for 10 minutes.
D.2. Test procedure
D.2.1. Fill the container with test fluid using the method specified by the manufacturer, removing the cap and replacing it if necessary.
D.2.2. You need to make sure that the container is properly placed and balanced in the centrifuge.
D.2.3. Centrifuge the filled container by subjecting its base to 3000 g for 10 minutes, then carefully place it in the rack and inspect it.
D.3. Test criteria
The container is considered to have passed the test if the container does not break, leak or crack.
Appendix E
(required)
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)]
Concentrations of dipotassium salt [CAS No. 25102-12-9], tripotassium salt [CAS No. 17572-97-3] and disodium salt [CAS No. 6381-92-6] should be in the range of 1, 2 to 2 mg anhydrous EDTA per 1 ml of blood [EDTA is 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 actual salt used for its water of crystallization.
E.2. Trisodium citrate
E.2.1. Trisodium citrate concentrations should range from 0.1 to 0.136 mol/L solution. The permitted tolerance for the specific volume of the additive must be ±10%.
E.2.2. For blood coagulation studies: 9 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.2.3. Westergren erythrocyte sedimentation rate: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.3. Fluoride/oxalate
Concentrations should range from 1 to 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 range from 1, 2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.
E.5. Fluoride/heparin
Concentrations should range from 12 to 30 international units of heparin and 2 to 4 mg of fluoride per ml of blood.
E.6. Sodium/Heparin [CAS No. 9041-08-1] Lithium/Heparin [CAS No. 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 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, sufficient quantity 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 volume of the additive must be within ±10%.
NOTE Additives can be presented in various physical forms, for example, in the form of a solution, a solid residue from a solution, evaporated by heat, 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 (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 |
Application YES
(informative)
Information on the compliance of interstate standards with reference international standards
Table DA.1
|
Designation and name of the reference international standard |
Degree of compliance |
Designation and name of the interstate standard |
|
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 Graphic symbols for use on equipment. Index and summary | ||
|
* There is no corresponding interstate standard. Before its approval, it is recommended to use the Russian translation of this international standard. |
||
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INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION
INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION
INTERSTATE
STANDARD
DISPOSABLE CONTAINERS FOR COLLECTION OF VENOUS BLOOD SAMPLES Technical requirements and test methods
(ISO 6710:1995, UT)
Official publication
GOST ISO 6710-2011
|
Standardinform |
Preface
The goals, basic principles and procedure for carrying out work on interstate standardization have been established 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 development, adoption, application, updating and cancellation"
Standard information
1 PREPARED by the Federal State Unitary Enterprise “All-Russian Research Institute of 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 (protocol dated November 29, 2011 No. 40)
4 By Order of the Federal Agency for Technical Regulation and Metrology dated December 13, 2011 No. 1379-st interstate standard GOST ISO 6710-2011 entered into force as a national standard of the Russian Federation on January 1, 2013.
5 This standard is identical to the international standard ISO 6710:1995 Single-use containers for venous blood specimen collection.
Degree of compliance - identical (UT).
The standard is prepared based on the application GOST R ISO 6710-2009
Information on the compliance of interstate standards with reference international standards is given in Additional Appendix DA
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 is published in the monthly published information index “National Standards”. In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index “National Standards”. Relevant information, notifications 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
© Standardinform, 2013
In the Russian Federation, this standard cannot be fully or partially reproduced, replicated and distributed as an official publication without permission from the Federal Agency for Technical Regulation and Metrology
Appendix C (mandatory)
Container leak testing
C.1 Reagents
C.1.1 A solution prepared by dissolving 2.5 g sodium fluorescein [uranine, CAS number 518-47-8] in 100 ml of 0.15 mol/l sodium chloride solution containing 60 g/l dextran 70 [no. CAS 9004-54-0] or equivalent.
C.1.2 Deionized water that does not fluoresce when observed under ultraviolet light (C.2.2) in a darkened room by an observer with normal or corrected-to-normal vision without special equipment.
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 tube shall be connected to a hollow tip of rigid material which ends in a conical constriction secured to a 6% luer fitting conforming to ISO 594-1.
C.2.2 Source of long-wave ultraviolet light.
C.2.3 Roller 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 the reagent (C. 1.1).
C.3.2 Remove the stopper from the test tube and fill it to the nominal capacity from the reservoir, avoiding contamination of the outer surface and edge of the test tube with the reagent. Insert the plug as specified by the manufacturer. Tighten the screw cap using the torque specified by the manufacturer. Insert the cap into place tightly into the neck of the test tube. Place the cap into place over the edges of the tube.
C.3.3 With normal or corrected to normal vision without magnifying devices, examine the container in a darkened room to ensure that its surface is not contaminated with the reagent. If necessary, wash off contaminants with water and examine under ultraviolet light as indicated above.
C.3.4 Roll the container on a roller mixer for 2 minutes or mix its contents as directed by the container manufacturer. Completely immerse the container in a container containing no more than 100 ml of water until the water completely covers the stopper. 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 the 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 reagent. After filling the container, separate it from the needle and, having washed the outer part of the tube and stopper from possible contamination with the reagent, examine it under ultraviolet light as described in C.3.3.
C.4.3 Perform the procedures described in C.3.4.
C.5 Procedure for containers intended to be filled or by perforating the stopper
or after removing the plug
C.5.1 Fill the reservoir with reagent (C. 1.1).
C.5.2 Fill as indicated below.
a) Filling by perforating the plug
Carefully insert the rigid tip of the tube through the perforated portion of the stopper and fill the container to its rated capacity from the reservoir, avoiding contamination of the outside of the container with reagent. After filling the container, disconnect it from the hard tip and, having washed the test tube and stopper from possible contamination with the reagent, examine the container under ultraviolet light as indicated in C.3.3.
b) Filling after removing the plug.
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 considered 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
Appendix D (mandatory)
Container strength tests
D.1 Reagents and equipment
D.1.1 Test fluid having the same relative density as normal human fluid
D.1.2 Blood sample container.
D.1.3 Centrifuge capable of subjecting the base of the container to centrifugal acceleration to 300°C for 10 minutes.
D.2 Test procedure
D.2.1 Fill the container with test fluid using the method specified by the manufacturer, removing the stopper 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 centrifugal acceleration for 10 minutes, then carefully place it in the rack and inspect it.
D.3 Test criteria
The container is considered to have passed the test if the container does not break, leak or crack.
Appendix 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)]
Concentrations of dipotassium salt [CAS No. 25102-12-9], tripotassium salt [CAS No. 17572-97-3] and disodium salt [CAS No. 6381-92-6] should be in the range of 1.2 to 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 actual salt used for its water of crystallization.
E.2 Trisodium citrate
E.2.1 Trisodium citrate concentrations should range from 0.1 to 0.136 mol/l solution. The permitted tolerance for the specific volume of the additive shall be ± 10%.
E.2.2 For blood coagulation studies: 9 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.2.3 Westergren erythrocyte sedimentation rate: 4 volumes of blood should be added to 1 volume of trisodium citrate solution.
E.Z Fluoride/oxalate
Concentrations should range from 1 to 3 mg potassium oxalate monohydrate [CAS No. 6487-48-5] (0.0039334 mol/L to 0.001 1 mol/L) and 2 to 4 mg sodium fluoride [CAS No. 7681- 49-4] (from 0.0476 mol/l to 0.0952 mol/l) per ml of blood.
E.4 Fluoride/EDTA
Concentrations should range from 1.2 to 2 mg EDTA and 2 to 4 mg fluoride per ml of blood.
E.5 Fluoride/heparin
Concentrations should range from 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 No. 77-92-9]....................2.99 g
Trisodium citrate (dihydrate) [CAS No. 77-92-9]....................26.3 g
Monobasic sodium phosphate ...................................2.22 g
Dextrose (monohydrate) [CAS No. 5996-10-1]...................31.9 g
Adenine ........................ 0.275 g
Water for injection, sufficient quantity 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 volume of the additive must be within ±10%.
Notes -Additives can be presented in various physical forms, for example, in the form of a solution, a solid residue from a solution, evaporated by heat, 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 (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 Pharmacopeia. 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 Pharmacopoeia Convention, Inc., Rockville, MD, USA
Appendix YES (reference)
Information on the compliance of interstate standards with reference international standards
|
Table YES. 1 |
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UDC 615.38.014.8:006.354 MKS 11.040.20 UT
Key words: disposable containers for venous blood collection, container testing, additives, labeling
Editor D.M. Kulchitsky Technical editor V.N. Prusakova Corrector M.S. Kabashova Computer layout L.A. Circular
Delivered for recruitment on 08/30/2013. Signed for publication on September 19, 2013. Format 60/84X - Headset Ariap. Uel. oven l. 1.86. Academic ed. l. 1.35. Circulation 58 copies. Zach. 1029.
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1 Scope of application...................................................1
3 Terms and definitions...................................................1
4 Materials................................................... .2
5 Capacity................................................... 2
6 Device................................................... .3
7 Design................................................... .3
8 Sterility................................................... 3
9 Additives................................................... ...3
10 Markings and labels...................................................3
11 Container identification...................................................4
Annex A (normative) Rated Capacity and Minimum Clearance Tests for Non-Vacuum Containers...................................6
Appendix B (mandatory) Tests of retracted (sucked) volume and minimum
free space for vacuum containers......7
Appendix C (normative) Container Leakage Tests......8
Annex D (mandatory) Container strength tests...................................9
Appendix E (normative) Additive concentrations and liquid additive volume...........10
Bibliography...................................................11
Appendix YES (reference) Information on the compliance of interstate standards with reference international standards....................................................11
INTERSTATE STANDARD
DISPOSABLE CONTAINERS FOR COLLECTION OF VENOUS BLOOD SAMPLES Technical requirements and test methods
Single-use containers for venous blood specimen collection. Technical requirements and test methods
Date of introduction -2013-01-01
1 area of use
This 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 or needle holders.
NOTE This standard replaces the requirements for non-vacuum containers previously specified in ISO 4822, Disposable blood specimen collection containers up to 25 ml, which has been cancelled.
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
The following terms with corresponding definitions are used in this standard:
3.1 container: A container for a blood sample, sealed with a stopper.
3.2 evacuated container: A container designed to collect blood using a vacuum created by the manufacturer (i.e., pre-vacuum container) or the user before blood collection.
3.3 tube: The part of a container without a stopper that contains a sample.
3.4 closure: Part by which a container is sealed.
3.5 primary pack: Direct packaging of containers.
3.6 container interior: The inner surface of the container.
3.7 additive: Any substance (not bound to the inside of a container) placed in a container to enable the intended analysis to be performed.
3.8 nominal capacity: The volume of whole blood that is expected to fill the container.
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 publication
3.10 fill line line marked on a tube and its label to indicate the nominal capacity of the container.
3.11 draw volume: The nominal capacity of a vacuum container.
3.12 expiration date: The date after which the manufacturer cannot guarantee that the container conforms to the requirements of this standard.
3.13 closing torque: The torque specified by the manufacturer that is required to tightly close a stopper using a wrench to seal a container tightly.
3.14 visual inspection: Inspection by an observer with normal or corrected-to-normal vision under uniform illumination from 300 to 750 lux.
4 Materials
4.1 The test tube must be made of a material that allows the contents of the container to be clearly visible upon visual inspection.
4.2 If a container is specifically intended for the examination of a particular substance, the maximum level of contamination of the interior of the container with that substance and the analytical method used should be indicated 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 precisely defined substances, the formula for the composition of the stopper material must be such that no interference occurs that affects the results.
NOTE For highly sensitive methods (e.g. using fluorometry) or for infrequently used tests, there may be no agreed interference limit. In such cases, the consumer is advised to consult the manufacturer.
4.3 Containers containing microbial preservative additives, such as trisodium citrate or citrate-phosphate-adenine-dextrose solution, should be inspected to ensure that there is no microbial contamination of the additive or the interior of the container.
NOTE The manufacturer is responsible for process validation. This standard does not specify a confirmation procedure, but a standard is under development.
4.4 The container must be free of foreign objects upon visual inspection.
5 Capacity
5.1 When tested in accordance with the methods specified in Annexes A and B, the volume of water added or drawn from the burette shall be within + 10% of the rated capacity.
5.2 To conduct tests in accordance with the methods given in Annexes A and B, sufficient free space must be provided in containers containing additives to ensure adequate mixing by mechanical and manual methods. The minimum headspace to permit adequate mixing shall be as specified in Table 1. It shall be assumed that the available headspace for mixing the contents of the container is limited by the bottom surface of the stopper and the liquid meniscus.
6 Device
6.1 The seal of the container shall not be compromised by mixing during the flow test in accordance with the methods specified in Annex C.
6.2 When the stopper is removed to gain access to the contents of the container, it must be possible to remove it with fingers or mechanically so that the part of the stopper 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 draw the contents of the blood sample container without removing the stopper.
6.3 When a container is leak tested in accordance with the method specified in Annex C, there shall be no fluorescence observed from the water in which the container is immersed.
7 Construction
7.1 When tested in accordance with the method specified in Annex D, the sample container, when centrifuged, must withstand an acceleration of up to 3000 g along the longitudinal axis.
Note - g n = 9.80665 m/s 2.
7.2 Visual inspection of the container should not reveal any sharp edges or rough surfaces that could accidentally cut, prick or abrade the user's skin.
8 Sterility
8.1 If the manufacturer guarantees that the device is sterile, the inside of the container and any contents thereof shall be subjected to a testing process designed to confirm that the inside of the unopened and unused container and any contents thereof are sterile.
NOTE The manufacturer is responsible for confirming the effectiveness of the process. This standard does not specify a procedure for the verification process, but a standard for control methods and processes for confirming sterilization is being developed. In the absence of national regulations, reference should be made to the current European Pharmacopoeia, the current US Pharmacopoeia or the current British Pharmacopoeia.
8.2 Sterility is required when blood collection involves direct contact between the inside of the container and the patient's bloodstream.
9 Additives
9.1 The specified nominal amount of additive must be within the limits specified in Appendix E.
NOTE With one exception (see 9.2), test methods are not specified.
If sodium, potassium or lithium is present in the additive, flame photometry is recommended. It is important that the accuracy of the test meets the error limits specified 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 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 tube.
10.2 The 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 the requirements for the product under normal conditions. However, when the product is stored or used under extreme conditions (extremes of 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 extraordinary or other than normal conditions.
10.3 Labeling on the outside of each primary package must contain the following information:
a) name and address of the manufacturer and supplier;
b) lot number;
c) expiration date;
d) a description of the contents, 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 inside of the unopened container and its contents are sterile;
"Disposable" inscription or graphic symbol in accordance with ISO 7000;
Storage requirements.
10.4 If the container is intended 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 must have the following information printed directly on the tube or label:
a) name or trademark of the manufacturer or supplier;
b) lot number;
c) letter code (see Table 2) and/or content description;
d) expiration date;
e) nominal capacity;
f) filling line, if necessary, for example for non-vacuum containers;
e) the inscription “sterile” if the manufacturer guarantees that the inside of the unopened and unused container and its contents are sterile.
If glycerin was used in the production of the container, this should be indicated on the label or packaging.
11 Container identification
Containers must be identified by the letter code and/or description of the additives given in Table 2. When using additives other than those listed in Table 2, containers must be identified by the description of the additive.
Note 1—There is currently no international agreement regarding color coding.
Note 2—When using color coding, the codes listed in Table 2 are recommended.
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Note 3—When color coding is used, it is recommended that the color of the stopper matches the color of the tube or label. |
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End of table 2 |
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Appendix A (mandatory)
Tests for rated capacity and minimum free space 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 with a capacity of 50 ml, 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 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, adjustments 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 valve and carefully release water into the container until the water meniscus reaches the level of the fill line, then close the valve.
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 released to the nearest ± 0.1 ml.
A.4 Test criteria
A.4.1 The container shall pass the rated capacity test if the volume of water discharged from the burette corresponds to ± 10% of the rated capacity.
A.4.2 A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested. .
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
GOST ISO 6710-2011
Appendix B (mandatory)
Tests of retracted (sucked) volume and minimum free space for vacuum containers
B.1 Reagents and equipment
B.1.1 Water, in accordance with ISO 3696, temperature 20 °C-25 °C.
B.1.2 Burette with a capacity of 50 ml, graduated in 0.1 ml divisions (accurate to ± 0.1 ml), with a tip at the bottom or side.
B.1.3 Clean silicone rubber tube (short).
B.1.4 Needles for blood collection in accordance with the recommendations of the container manufacturer.
B.2 Tests for retracted (sucked) volume
B.2.1 Test conditions
B.2.1.1 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, adjustments 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 it is supplied unassembled, insert the needle into the holder in accordance with the instructions of the container manufacturer.
B.2.2.2 Fill the burette with water, open the burette tap and let water flow through the filling clamp of the silicone rubber tube; leave the burette empty.
B.2.2.3 Insert the outer needle of the “blood collection needle/needle holder” complex through the wall of the silicone tube until the needle enters the lumen of the tube.
B.2.2.4 Connect the container to the needle/holder complex in accordance with the container manufacturer's instructions.
B.2.2.5 Fill the container for at least one minute or as specified by the manufacturer.
B.2.3 Test criteria
The container can pass the test if the volume of water drawn in is equal to the nominal capacity ± 10%.
B.3 Minimum clearance tests
B.3.1 Test conditions
B.3.1.1 Tests must be carried out at an atmospheric pressure of 101 kPa and an ambient temperature of 20 °C; when testing under other conditions, adjustments must be made.
B.3.1.2 Unused containers should be tested.
B.3.2 Test procedure
B.3.2.1 Separate 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 test tube under the outlet valve of the burette.
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 drawn-in test (see B.2) from the total volume of water released from the burette.
B.3.3 Test criteria
A 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 liquid meniscus, such space is not less than that indicated in Table 1 for containers of the type tested.
NOTE Stoppers vary in shape and, in particular, the side that comes into contact with the blood may protrude from the neck of the tube, split, or have a distinct concave or convex profile. These shape features may affect the available free space, which must be taken into account when interpreting test results. If necessary, the influence of the stopper geometry can be determined by measuring, for example, the length of the closure portion of the stopper or the excess volume due to the concave shape of the stopper.
