YY/T 0681.14-2018 English PDF (YY/T0681.14-2018)

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YY/T 0681.14-2018: Test methods for sterile medical device package - Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
YY/T 0681.14-2018
Test methods for sterile medical device package.Part 14. Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
ICS 11.080.040
C31
People's Republic of China Pharmaceutical Industry Standard
Sterile medical device packaging test method
Part 14. Breathable packaging materials for wetness and dryness
Microbial barrier test
Part 14. Testingthemicrobialbarrierforporouspackagingmaterialsunder
Published on.2018-11-07
2019-11-01 implementation
State Drug Administration issued
Foreword
YY/T 0681 "Test Method for Packaging Materials for Sterile Medical Devices" is divided into the following sections.
---Part 1. Guide to accelerated aging test;
---Part 2. Sealing strength of soft barrier materials;
--- Part 3. Unconstrained packaging against internal pressure damage;
--- Part 4. Determination of seal leakage of breathable packaging by dyeing liquid penetration method;
--- Part 5. Internal pressure method to detect coarse leakage (bubble method);
---Part 6. Evaluation of the chemical resistance of ink and coating on flexible packaging materials;
--- Part 7. Evaluation of ink or coating adhesion on flexible packaging materials with tape;
---Part 8. Determination of the weight of the coating layer;
---Part 9. Sealing plate internal pressure method soft package sealing burst test;
---Part 10. Microbial barrier grading test for breathable packaging materials;
--- Part 11. Visual inspection of medical packaging seal integrity;
--- Part 12. Soft barrier film resistance;
--- Part 13. Soft barrier film and composite film resistance to slow puncture;
--- Part 14. Tests for wet and dry microbial barriers for breathable packaging materials.
This part is the 14th part of YY/T 0681.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, DuPont (China) R and D Management Co., Ltd., Divisional Trade
(Shanghai Co., Ltd.
The main drafters of this section. Wang Wenqing, Qian Jun, Liu Shiliang, Hao Jianxin.
introduction
Breathable packaging materials for medical device sterilization are often provided to medical institutions and medical device manufacturers. Due to two situations such as extinction
The differences in bacterial methods, transport conditions, storage conditions, and shelf life have different requirements for their microbial barrier properties.
This part of YY/T 0681 is technically equivalent to DIN58953-6.2010. Health and safety review of disinfection products issued by the health department
The price regulation stipulates that the package of sterilized articles with a sterilization mark shall be subjected to a microbial barrier test, and the "Disinfection Technical Specifications" gives corresponding
Test method. The test method specified in this standard is consistent with the principle of the method given in the Disinfection Technical Specification (2002 edition).
Medical device manufacturers are required to comprehensively evaluate the microbial barrier properties of breathable packaging materials in accordance with the requirements of GB/T 19633.1.
The test conditions given in this part of YY/T 0681 are relatively low and easy to promote. However, medical device manufacturers are evaluating one
When using the YY/T 0681 part of the MN/T 0681 for the microbial barrier properties of the venting material, the following aspects must be carefully considered.
--- The repeatability and reproducibility results of the test methods given are not very satisfactory (see Appendix A);
--- The acceptance criteria given are still somewhat controversial in the industry.
Sterile medical device packaging test method
Part 14. Breathable packaging materials for wetness and dryness
Microbial barrier test
1 Scope
This section specifies test methods for microbial barrier tests for wet and dry conditions.
The test methods given in this section apply to the packaging materials for terminally sterilized medical devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 450-2008 Determination of paper and paperboard specimens and determination of longitudinal, lateral and frontal surfaces of specimens
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 wet conditions microbial barrier test
3.1 Method summary
The microbial droplets were dropped onto the test sample. After the droplets are dried, a test is performed to determine if microorganisms penetrate into the test sample.
the other side.
3.2 Sampling
Sampling according to GB/T 450-2008.
3.3 Sample preparation and quantity
A square having a side length of about 50 mm was cut from the packaging material to be tested for testing. Should be tested according to the manufacturer or customer instructions
The sample is sterilized.
The sample was conditioned for at least 24 h in an environment with a temperature of (23 ± 1) ° C and a relative atmospheric humidity of (50 ± 2)%.
Note. Wet packaging materials can produce false results.
It is advisable to use 5 test samples for each batch of packaging materials, see 3.7.
3.4 medium
3.4.1 General
The medium was prepared using freshly prepared distilled water. Do not use deionized water. Can also be used if there is no newly prepared distilled water
Water for Injection.
The quality of the required reagents can be found in the relevant regulations of the Pharmacopoeia of the People's Republic of China (2015 edition).