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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0681.10-2011: Test methods for sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material Status: Valid
Basic dataStandard 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. 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 ForewordYY/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.IntroductionASTM 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 test1 ScopeTest 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 referencesThe 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 testing3 Terms and DefinitionsThe 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 Method4.1 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 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0681.10-2011_English be delivered?Answer: Upon your order, we will start to translate YY/T 0681.10-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0681.10-2011_English with my colleagues?Answer: Yes. 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