YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging

Scope

1.1 This part of YY/T 0681 provides information for preparing accelerated aging programs, in order to quickly determine the sterility integrity of packaging and the physical properties of packaging materials affected by the time and environment they have experienced.
1.2 The information obtained in this part can be used to support the effective date given on the product packaging.
1.3 The accelerated aging guidelines involve the overall primary packaging, not the interaction or compatibility between the packaging and the product, which may need to be considered in the development of new products. The compatibility and interaction between the packaging and the product should be considered during the material analysis process before packaging design.
1.4 This part does not involve actual time aging programs, but conducting actual time aging studies can be used to verify the results of accelerated aging tests using the same evaluation methods.
1.5 Methods used for packaging process confirmation, including mechanical processes, sterilization processes, transportation, and storage effects, are also not within the scope of this part.
1.6 This part does not address all safety aspects of its use. It is the responsibility of the users of this part to establish corresponding safety and health procedures and ensure their compliance with regulatory requirements before using this part.

Development Information

Superseded by the following standards

Referenced Standards

Adopt standards

Related Standards