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YY/T 0681.10-2011: Test methods for sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material
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Test methods for sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material
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YY/T 0681.10-2011
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Basic data | Standard ID | YY/T 0681.10-2011 (YY/T0681.10-2011) | | Description (Translated English) | Test methods for sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 18,182 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 10739 | | Adopted Standard | ASTM F1608-2000, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to the determination of airborne bacteria used for the packaging of sterile medical equipment breathable material penetration. This test method is designed to penetrate the bacterial spores of the test material to the material under test conditions, so that the material classification. The microbiological test methods need to operate only by trained personnel to operate. | YY/T 0681.10-2011: Test methods for sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material
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Test methods for sterile medical device package.Part 10. Test for microbial barrier ranking of porous package material
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Test methods for packaging sterile medical devices
Part 10. breathable packaging material microorganisms
Barrier grading test
Part 10. Testformicrobialbarrierrankingofporouspackagematerial
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0681 "sterile medical device packaging test method", consists of the following components.
--- Part 1. accelerated aging test guidelines;
--- Part 2. sealing strength flexible barrier material;
--- Part 3. Unconstrained pressure within the package of anti-sabotage;
--- Part 4. Determination of staining solution penetrate breathable packaging seal leakage;
--- Part 5. coarse leak was detected internal pressure (bubble method);
--- Part 6. flexible packaging material and ink coating chemical resistance evaluation;
--- Part 7. flexible packaging material ink or coating adhesion tape evaluation;
--- Part 8. coating layer weight determination;
--- Part 9. constraint plate internal pressure bursting test method flexible seal;
--- Part 10. permeable microbial barrier packaging material grading tests.
This section YY/T Part of 100,681.
YY/T 0681 to modify this part of the technical aspects of using ASTMF1608-00 "permeable microbial barrier packaging material grading test side
Law (chamber method). "
This section drafted in accordance with GB/T 1.1-2009 given rules.
This part is proposed by the State Food and Drug Administration.
This part of the National medical infusion apparatus of Standards and Technology Committee (SAC/TC106) centralized.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center, Ltd. Shandong Xinhua.
Drafters of this section. Wang Wenqing, Wu Ping, Zhang step increase, Zhong Wenquan.
Introduction
ASTM had 11 laboratories participated in the collaborative study laboratory. Repeat the test laboratories of six commercially available breathable material like
Reduce the product to determine the log value (LRV). Under standard conditions specified in this test method to test materials were tested, the average fed back
The values range from LRV 1.7 to LRV 4.3.
The results of the laboratory collaborative study showed that when comparing experimental data and materials to be cautious when a given level, especially for repeat sample
When the number of tests carried out much. In addition, this test method used to develop packaging performance standards, the need for further cooperation among laboratories
For research.
Test methods for packaging sterile medical devices
Part 10. breathable packaging material microorganisms
Barrier grading test
1 Scope
Test methods YY/T 0681 provisions of this Part for the determination of airborne bacteria permeable material for the packaging of sterile medical devices
Penetrating. This test method is designed to be able to penetrate the bacterial spores in the test material conditions of the material tested, in order to facilitate the material
Be graded.
This test method requires operation microorganism only by trained personnel to operate.
NOTE. This test method precision and bias of the information in Appendix B.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Standard atmospheric conditions GB/T 10739 paper, paperboard and pulp sample processing and testing
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Breathable packaging material porouspackagematerial
Medical packaging used to provide environmental and biological barriers, while gas sterilization (such as ethylene oxide, steam, gas plasma
Body) to make adequate airflow through the material.
4 Summary of Test Method
4.1 Overview
Breathable material in the test chamber so that the sample is subjected to shrink Bacillus spore aerosol challenge. Breathable membrane filter to collect spores penetrate the sample
And its count. Numerical challenge with spores of the number of spores and penetration breathable material difference between the value of the number of calculated log reduction value (LRV).
4.2 standard conditions set
This test method specifies the standard conditions set. Standard material condition setting enables evaluation of inter-laboratory comparability. This test side
Factors determining standard conditions described by law, have many. First, it is difficult to maintain in the long term aerosol spores (spore challenge too long,
Will increase the cost of testing). Second, to determine the differences between the materials, it needs to be tested under conditions make bacterial spores penetrate.
If a material is not penetrate any spores, which can be expressed as a more stringent conditions than the challenge of barrier properties. Third, make all commercially available
Breathable material within the scope of the inspection can be bacillus penetration, we need to have a big challenge spore level. Standard conditions the method described
Based on these factors is set. However, due to the factors affecting the determination of many of breathable material (see Chapter 5), under standard conditions the user
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