YY 0314-2007 English PDF

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YY 0314-2007: [Including YY 0314-2013XG] Single-use containers for venous blood specimen collection
YY 0314-2007
Single-use containers for venous blood specimen collection
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0314-1999
Disposable human blood sample collection container
(EN14820.2004,MOD)
Published on.2007-07-02
2008-08-01 Implementation
The State Food and Drug Administration issued
Foreword
This standard changes the use of EN14820.2004 "one-time use of venous blood collection containers", technical changes and their causes, see Appendix ND.
This standard replaces YY 0314-1999 "Disposable venous blood sampling container".
Compared with YY 0314-1999, the changes in technical content mainly include.
--- Added "scale mark and filling line" (Chapter 6), canceling the quantitative requirements for free space;
--- Added content of specific microbial status;
--- Adjust the contents of Appendix E "Additive Concentration and Volume of Liquid Additives" of the original standard to informative annexes (Appendix NC);
--- Added an informative annex NA, recommended the method of environmental atmospheric calibration;
--- Added informative Appendix NB, recommended the use of pre-vacuum suction volume test method for high altitude areas.
Appendix A, Appendix B, Appendix C and Appendix D of this standard are normative appendices, Appendix NA, Appendix NB, Appendix NC and Appendix ND
Is an informative appendix.
This standard is proposed and managed by the National Standardization Technical Committee for Medical Infusion Devices.
This standard is mainly drafted by. Shandong Provincial Medical Device Product Quality Inspection Center, BD Medical Devices Co., Ltd.
The main drafters of this standard. Wu Ping, Song Gold, Jiang Yundan, Sun Guangyu.
introduction
This standard provides the requirements for a venous blood sample container (blood collection tube). Due to changes in blood vessel production technology, some European countries
The family strongly urged the revision of ISO 6710.1995. Some countries strongly demand that blood collection tubes be color-coded for patient safety considerations. Currently used
There are two established colour-labeling systems and there have been no reports of safety impacts on the patients due to the different colours. The uniform color scale is only
development trend. Any change in this aspect of the manufacturer will increase production costs, which will increase the user's purchase price. Therefore, internationally
It is too possible to reach an agreement on the color-matching of blood collection tubes. Therefore, in international standards, the color standard is no longer recommended on the advice of the majority of the members, but this standard is still
Give a color code recommendation.
YY 0314-1999 is equivalent to adopting ISO 6710.1995, and the revised ISO 6710 has not been coordinated due to the issue of the color standard.
This standard uses EN14820.2004. The committee will also closely follow the revision of the ISO 6710 standard.
For vacuum blood collection tubes, the accuracy of blood sample collection is mainly determined by the degree of vacuum in the blood collection tube and the atmospheric pressure at which the blood is collected (mainly
Affected by altitude) and the effect of the volume of the blood collection needle. In order to meet the clinical use requirements of blood collection tubes, in addition to the requirements of blood collection tubes have good
In addition to air retentivity, it is recommended that manufacturers make amendments to the local atmosphere at the time of production, expressly apply the altitude range, and provide appropriate
Used intravenous blood collection needles.
Note. Appendix NA and Appendix NB recommend methods for correcting the atmospheric environment of the collection volume and methods for measuring the collection volume of blood collection tubes at high altitudes.
Disposable human blood sample collection container
1 range
This standard specifies the collection of human venous blood sample tubes intended for one-time use by the manufacturer for in vitro diagnostic tests (abbreviated as
Requirements and test methods for tubes) This standard also applies to blood collection tubes containing medium for blood cultures.
This standard does not stipulate requirements for peripheral blood sample collection tubes or arterial blood sample collection devices. This standard does not stipulate the use of non-blood samples for single use
The collection tube requirements and test methods.
2 Normative references
The clauses in the following documents have been adopted as references to this standard. All dated references, all subsequent
The amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to reach an agreement according to this standard
Can you use the latest version of these files? For undated references, the latest version is applicable to this standard.
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) conical connectors Part 1. General requirements
(GB/T 1962.1-2001, idt ISO 594-1.1986)
GB/T 6682-1992 Analysis of laboratory water specifications and test methods (neq ISO 3696.1987)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
In order to carry out a predetermined test, substances placed in the blood collection tube to facilitate preservation of the blood sample or intended to react with the blood sample (not included)
Non-removable substances treated on the inner surface).
3.2
Collect all components required for blood samples.
3.3
Manufacturers specify the torque required to tighten the stopper with a torque wrench to seal the blood collection tube.
3.4
Closed container components.
3.5
Blood collection tubes were used to remove appendages and stoppers for blood sampling.
Note. Depending on the application, the blood collection part of the blood sample can also be referred to as a "tube," "bottle," "tube," or other similar name.
3.6
The volume of liquid sample drawn into the vacuum tube.
3.7
The blood sampling tube is collected by evacuation. The vacuum vessel is formed at the time of production (ie, prevacuum blood collection tube) or by
The user formed before sampling.
3.8
Blood collection tubes should not be used after this date.
3.9
The volume of liquid sample required to achieve the specified additive to sample ratio.
3.10
Gives the contents of the blood collection tube an extra amount of mixing or head space.
3.11
The volume of the collected sample can be estimated on the container or on its label.
3.12
A method for determining the volume of a liquid by weighing and correcting the mass density of the liquid.
Note. In this standard, it is considered that the weight of 1000mL of water is 1000g.
3.13
Marked on the container or on its label to indicate the maximum sample size required for accurate results when used in in vitro diagnostic tests
volume.
3.14
Labeled on the container or on its label to indicate the minimum sample size required for accurate results when used in in vitro diagnostic tests
volume.
3.15
A device used to connect to a vacuum blood collection tube and to perform venipuncture and blood collection.
3.16
Blood collection tubes are used to contain the volume of sample and additives.
Note. This volume is stated on the label and/or in the instruction manual.
3.17
Marked on the container or on its label to indicate the nominal fluid volume of the blood collection tube.
3.18
The smallest package of blood collection tubes.
3.19
Vacuum or non-vacuum vessels for loading samples with add-ons, additives, and stoppers.
3.20
The producer places inside the blood collection tube to help collect, mix, or separate the components of the sample.
Note. Vascular appendages are for example small plastic inert spheres (or separate gel pieces) placed in serum or plasma blood collection tubes and used for centrifugation and separation from blood.
Serum or plasma.
3.21
The inner surface of the blood collection tube or stopper and the surface where the blood collection additive is in contact with the sample.
3.22
The obtained biological material (such as venous blood) is used to detect its characteristics or measure one or more characteristics.
3.23
In the range of 300lx to 750lx average illuminance without amplification, the observer was examined with normal or corrected vision.
4 Materials
4.1 If the blood collection tube is intended to contain a sample for a particular test, stopper, container, internal coating, additive or additive (if any)
Materials may affect the final test results, then the maximum amount of contamination of these substances and the method of analysis used by them should be
Attached on the accompanying documents, or on labels or packaging (see also 11.3). The manufacturer is responsible for the suitability of the intended use of materials and blood collection tubes.
OK confirmation.
Note 1. This standard does not specify the procedure for confirming the suitability of materials.
Note 2. For some unconventional clinical tests, the interference limit may not have been determined. It is recommended that users consult the manufacturer.
Note 3. The container should be made of a material that can clearly observe the contents (unless the quality of the contents is reduced under ultraviolet light or visible light) so that the viewer can see normal
Or corrected visual acuity in the average illuminance of 300lx ~ 750lx, and without magnification under visual inspection (see 3.22).
Note 4. If the container is made of a material that cannot be visually inspected for a clear view of the contents, the stopper can be removed to check the contents.
4.2 The blood collection tube material should not contain impurities during the visual inspection.
4.3 Blood collection tubes filled with microorganisms to facilitate additives should be subjected to a confirmatory process to remove the additives and microscopic inside the blood collection tube.
Biological contamination. The confirmation of this process shall be the responsibility of the manufacturer.
Note. For confirmation and routine control of sterilization process, see GB 18278, GB 18279 and GB 18280.
5 nominal liquid capacity
5.1 When tested in accordance with the method specified in Appendix A or Appendix B, the volume of water added or extracted from the burette plus the volume of the additive shall be
Between 90% and 110% of the nominal capacity.
5.2 For cartridges containing additives, a free space or other physical mixing method should be provided for shaking.
5.3 When using free space for mixing, leave enough mechanical or manual mixing free space.
5.4 Manufacturers should confirm how to mix blood samples and additives thoroughly.
Note. This standard does not stipulate the confirmation procedure for thorough mixing of blood samples.
6 scale mark and filling line
When testing the vacuum blood collection tubes marked with filling lines on the container or on the label of the container according to the method specified in Appendix B, the volume of liquid filled shall be
Not more than or not less than 10% of the filling capacity.
When the non-vacuum blood vessel with scale mark is tested according to the method specified in Appendix A, the volume of water should be 90% of the mark volume.
Between 110%.
Note. see section A. Chapter 4 notes.
7 Design
7.1 When the container leak test is performed in accordance with the method specified in Appendix C, the plug should not be loosened. The blood collection tube should pass this leak test, ie it is not tested
Fluorescence.
7.2 When the plug is intended to be removed in order to facilitate removal of the contents of the blood collection tube, its design should be reasonable and easy to use so that it can be used with fingers and
(or) The mechanical device is held and removed, and the finger or mechanical device cannot touch the portion of the plug that is in contact with the blood sample to avoid contamination.
Note. The blood collection tube should be designed to be opened as much as possible to avoid the natural spillage of the contents. This standard does not stipulate this test method because of the design of a passenger
It is not yet possible to view repetitive experiments.
7.3 When the blood collection tube is subjected to a leak test in accordance with the test method specified in Appendix C, fluorescence should not be detected in the water soaked in blood collection tubes.
8 Structure
8.1 According to the requirements of the manufacturer's instructions, the blood collection tube should be capable of withstanding and removing the stopper 4 times, and according to Appendix A, Appendix B, Appendix C and Appendix
In the D test, blood collection tubes should be free of breakage, collapse, rupture, or other visible damage. If the plug is damaged when you first open the blood collection tube, then this
Some of the requirements should still apply to the stopper.
Note 1. This requirement does not apply to seals that remain after opening.
Note 2. The specified strength test method is very difficult. The above stated requirements are expected to be simulated during normal filling of blood collection tubes, storage, transportation and removal of samples.
Mechanical stress. The requirements for the transport of samples in blood collection tubes are found in UN650 [6].
(Accelerator-specified acceleration) centrifugal acceleration without breaks, collapses, cracks, or other visible defects.
8.3 When visually inspected, there shall be no sharp edges or burrs on the blood collection tube that could accidentally scratch, puncture or grind the user's skin or gloves.
Or rough surface.
9 Sterile and specific microbial status
9.1 If the manufacturer claims that the inside or the entire blood collection tube of an unopened and unused cartridge is aseptic or in a specific microbiological state
State, then the interior of the container and its additives or additives should be achieved through a confirmed process.
Note. For confirmation and routine control of sterilization process, see GB 18278, GB 18279 and GB 18280.
9.2 If the container is collecting blood samples, there is a possibility of direct contact between...