Test methods for sterile medical device package
- Part1: Test guide for accelerated aging
1 Scope
1.1 This part of YY/T 0681 provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity of packages and the physical properties of their component packaging materials.
1.2 Information obtained using this part may be used to support expiration date claims for product packages.
1.3 The accelerated aging guideline addresses the primary medical package in whole and does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
1.4 Real-time aging protocols are not addressed in this part; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for package process validation, which include the machine process, the effects of the sterilization process, transport and storage, are beyond the scope of this part.
1.6 This part does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this part to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0681. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part of YY/T 0681. However parties to agreements based on this part of YY/T 0681 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 4857.2 Packaging - Basic tests for transport packages - Part 2: Temperature and humidity conditioning (GB/T 4857.2-2005; ISO 2233: 2000, MOD)
GB/T 11605-2005 Methods of humidity measurement
GB/T 15171 Test method for leaks in sealed flexible packages
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005; ISO 11607: 2003, IDT)
ASTM D 4169 Practice for performance testing of shipping containers and systems
ASTM F 88 Test method for seal strength of flexible barrier materials
ASTM F 1140 Test methods for internal pressurization failure resistance of unrestrained packages for medical applications
ASTM F 1585 Guide for integrity testing of porous barrier medical packages
ASTM F 1608 Test method for microbial ranking of porous packaging materials (exposure chamber method)
ASTM F 1929 Test method for detecting seal leaks in porous medical packaging by dye penetration
3 Terms and definitions
3.1 General terms
For the purposes of this part of YY/T 0681, the terms and definitions given in GB/T 19633 apply.
3.2 special terms
3.2.1
accelerated aging (AA)
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Significance and use
5 Apparatus
6 Accelerated aging theory
7 Accelerated aging plan
8 Post-aging testing guidance
9 Documentation
Annex A (Normative) Accelerated aging of polymers
Annex B (Informative) Example package shelf-life test plan
Bibliography
Test methods for sterile medical device package
- Part1: Test guide for accelerated aging
1 Scope
1.1 This part of YY/T 0681 provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity of packages and the physical properties of their component packaging materials.
1.2 Information obtained using this part may be used to support expiration date claims for product packages.
1.3 The accelerated aging guideline addresses the primary medical package in whole and does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
1.4 Real-time aging protocols are not addressed in this part; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for package process validation, which include the machine process, the effects of the sterilization process, transport and storage, are beyond the scope of this part.
1.6 This part does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this part to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0681. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part of YY/T 0681. However parties to agreements based on this part of YY/T 0681 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 4857.2 Packaging - Basic tests for transport packages - Part 2: Temperature and humidity conditioning (GB/T 4857.2-2005; ISO 2233: 2000, MOD)
GB/T 11605-2005 Methods of humidity measurement
GB/T 15171 Test method for leaks in sealed flexible packages
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005; ISO 11607: 2003, IDT)
ASTM D 4169 Practice for performance testing of shipping containers and systems
ASTM F 88 Test method for seal strength of flexible barrier materials
ASTM F 1140 Test methods for internal pressurization failure resistance of unrestrained packages for medical applications
ASTM F 1585 Guide for integrity testing of porous barrier medical packages
ASTM F 1608 Test method for microbial ranking of porous packaging materials (exposure chamber method)
ASTM F 1929 Test method for detecting seal leaks in porous medical packaging by dye penetration
3 Terms and definitions
3.1 General terms
For the purposes of this part of YY/T 0681, the terms and definitions given in GB/T 19633 apply.
3.2 special terms
3.2.1
accelerated aging (AA)
Contents of YY/T 0681.1-2009
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Significance and use
5 Apparatus
6 Accelerated aging theory
7 Accelerated aging plan
8 Post-aging testing guidance
9 Documentation
Annex A (Normative) Accelerated aging of polymers
Annex B (Informative) Example package shelf-life test plan
Bibliography
