YY/T 0681.1-2009 (English Version) PDF

Scope: This part of YY/T 0681 provides information for the preparation of accelerated aging protocols to quickly determine the sterility integrity of packaging and the physical properties of packaging materials affected by the time and environment experienced. The information obtained using this section can be used to support the expiry date given on the product packaging. The accelerated aging guidance covers the initial packaging as a whole and does not address the interaction or compatibility between packaging and product, which may need to be addressed in the development of new products. This section does not involve real-time aging schemes during material analysis prior to packaging design, but performing real-time aging studies can be used to confirm the results of accelerated aging tests using the same evaluation method. Methods used to validate the packaging process, including the effects of mechanical processes, sterilization processes, transportation, and storage, are also outside the scope of this standard. This section does not cover all safety considerations for its use. It is the responsibility of the user of this section to establish appropriate safety and health procedures and determine compliance with regulatory requirements before using this section.

YY/T 0681.1-2009 Referenced Document

ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages*， 2024-04-19 Update
ASTM F1585 Standard Guide for Integrity Testing of Porous Barrier Medical Packages
ASTM F1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)*， 2021-10-01 Update
ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials*， 2024-04-19 Update
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 4857.2 Packaging-Basic tests for transport packages-Part 2:Temperature and humidity conditioning

2018 YY/T 0681.1-2018 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests
2009 YY/T 0681.1-2009 Test methods for sterile medical device package.Part 1:Test guide for accelerated aging