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YY/T 0681.1-2009 (YY/T0681.1-2009)

Chinese standards (related to): 'YY/T 0681.1-2009'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY/T 0681.1-2018English205 Add to Cart 0-9 seconds. Auto delivery. Test methods for sterile medical device package--Part 1: Test guide for accelerated aging YY/T 0681.1-2018 Valid YYT 0681.1-2018
YY/T 0681.1-2009English479 Add to Cart 3 days Test methods for sterile medical device package. Part 1: Test guide for accelerated aging YY/T 0681.1-2009 Obsolete YYT 0681.1-2009

Standard ID YY/T 0681.1-2009 (YY/T0681.1-2009)
Description (Translated English) Test methods for sterile medical device package. Part 1: Test guide for accelerated aging
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.080.040
Word Count Estimation 12,136
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Quoted Standard GB/T 4857.2; GB/T 11605-2005; GB/T 15171; GB/T 19633; ASTM D 4169; ASTM F 88; ASTM F 1140; ASTM F 1585; ASTM F 1608; ASTM F 1929
Adopted Standard ASTM F 1980-2002, MOD
Drafting Organization Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization National Technical Committee of Standardization for medical infusion
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to the preparation of accelerated aging programs in order to quickly determine the integrity of aseptic packaging and packaging materials by the physical characteristics of the elapsed time and the environmental impact. Use the information obtained in this section can be used to support the effective date given product packaging. Accelerated aging guide covers the early packing whole, does not involve the interaction between packaging and product compatibility, etc., or in the development of new products which may be required in areas covered. Before designing the packaging material analyzed Cheng Zhongyi related to packaging and product compatibility and interaction. This part does not involve the aging of the real time program, but the actual time of aging studies can be used to confirm that the same evaluation method of accelerated aging tests. For packaging process validation methods, including mechanical processes, the sterilization process, transport, storage effects are not within the scope of this section. This section does not involve the use of all of the safety concerns, in this section before use to establish appropriate safety and health practices and determine its compliance with regulatory requirements is the responsibility of the user of this part.