Superseded

YY/T 0681.1-2009Test methods for sterile medical device package - Part 1: Test guide for accelerated aging (English PDF)

无菌医疗器械包装试验方法第1部分：加速老化试验指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 16, 2009

Implementation date

December 1, 2010

Scope

YY/T 0681.1-2009 is the English-translated version of 无菌医疗器械包装试验方法第1部分：加速老化试验指南.

YY/T 0681.1-2009 is the Chinese standard "Test methods for sterile medical device package - Part 1: Test guide for accelerated aging".

Its scope clause reads: 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.

Information obtained using this part may be used to support expiration date claims for product packages. 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. 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. Its clauses include terms and definitions.

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Document preview — YY/T 0681.1-2009

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

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

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)

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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