YY/T 0681.9-2011 Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates

Scope

The test method specified in this part of YY/T 0681 prescribes a method for testing the minimum bursting strength of the peripheral seals of soft packages by subjecting them to internal pressurization when placed in a restraining board.
This test is only applicable to soft packages with peripheral seals (commonly referred to as composite bags). It is particularly suitable for packages whose seals have a peelable feature (allowing end users to remove the contents after opening them).
Users of this method are advised to pay special attention to the fact that it may be necessary to design and manufacture restraining board fixtures. For details on pressure factors and structural design considerations, please refer to Informative Appendix C.

Development Information

Same series standard

Referenced Standards

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