YY/T 0681.1-2009 (YY/T0681.1-2009, YYT 0681.1-2009, YYT0681.1-2009)
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Test methods for sterile medical device package. Part 1: Test guide for accelerated aging
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Test methods for sterile medical device package--Part 1: Test guide for accelerated aging
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YY/T 0681.1-2018
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Newer version: YY/T 0681.1-2018 Standards related to: YY/T 0681.1-2018
| 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. | YY/T 0681.1-2009
Test methods for sterile medical device package.Part 1. Test guide for accelerated aging
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Test methods for packaging sterile medical devices
Part 1. Guide to the accelerated aging test
(ASTMF1980. 02, MOD)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
This section YY/T 0681 amendments adopted ASTMF1980-02 "sterile medical device packaging standard accelerated aging test guidelines." this
Portion ASTMF1980-02 technical content equivalent, mainly editorial differences and the difference between the standard reference difference.
This section is normative Appendix Appendix A and Appendix B is an informative annex.
Other parts of YY/T 0681 "Test Method for sterile medical device packaging" will continue to develop 1).
This part of the National Infusion equipment for medical Standardization Technical Committee.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center, Guangdong Provincial Medical Device Supervision and Inspection.
The main drafters of this section. Wu Ping, Hong Liang Tong, Hu Xianghua, He Xiaofan.
1) conversion of the rest of the Test Method ASTMF standards for medical packaging.
Test methods for packaging sterile medical devices
Part 1. Guide to the accelerated aging test
1 Scope
1.1 YY/T 0681 into the preparation of Part accelerated aging program provides information to quickly determine the integrity of the sterile packaging and packaging
Physical properties of the materials affected by the elapsed time and the environment.
1.2 Information obtained by this section can be used to support the effective date of the product packaging is given.
1.3 accelerated aging guide covers primary package as a whole, it does not involve interaction or compatibility between products like packaging and development of new products in these
It may be required in respect of the involved. Material prior to packaging design analysis over Cheng Zhongyi relates to the compatibility and interaction of packaging and products.
Plus 1.4 does not deal with the actual time of the aging program, but the actual time aging studies can be used to confirm the same evaluation method
The results of the accelerated aging test.
1.5 Method for the packaging process validation, including mechanical process, sterilization, transportation and storage of the impact is not within the scope of this section.
1.6 This section does not involve the use of all safety considerations before using this section to establish appropriate safety and health practices and determine
It complies with regulations given in this section is the user's responsibility.
2 Normative references
The following documents contain provisions which, through reference YY/T 0681 and become part of the provisions of this section. For dated references,
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section
Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB/T 4857.2 Basic tests for transport packages - Part 2. Temperature and humidity adjustment process (GB/T 4857.2-2005,
ISO 2233.2000, MOD)
GB/T 11605-2005 humidity measurement
GB/T 15171 pieces of flexible sealing performance test method
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005, ISO 11607.2003, IDT)
Performance tests ASTMD4169 shipping containers and systems
Test methods ASTMF88 soft seal strength of the barrier material
ASTMF1140 medical flexible without pressure destruction test methods within tiedown
ASTMF1585 permeability barrier medical packaging integrity test guidelines
Microbial barrier Level Test Method ASTMF1608 Medical Packaging breathable packaging material
Test methods for porous material medical packaging seal leakage ASTMF1929 determined by staining liquid penetration method
3 Terms and Definitions
3.1 generic term
Terms and definitions GB/T 19633 apply to established YY/T 0681 to the present section.
3.2 terminology
3.2.1
The samples were stored at a higher temperature (TAA), in order to shorten the time to simulate the aging of the actual time.
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