T/CAMDI 009.10-2020 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination

Scope

Main technical content: T/CAMDI 009 This part specifies the pollution limit requirements for the primary packaging of sterile medical devices and the particulate matter in primary packaging materials according to the test method of T/CAMDI 009.1. Note: This part of T/CAMDI 009 only sets limit indicators for packaging materials based on the test method given in T/CAMDI 009.1. Depending on the development of the T/CAMDI 009 series of standards, corresponding pollution limit indicators may also be given for the test methods of other parts of T/CAMDI 009 in this document in the future, such as the limit of biological load and the limit of intracellular toxins. This part of T/CAMDI 009 is applicable to manufacturers of primary packaging of sterile medical devices and primary packaging materials, as well as to manufacturers of sterile medical devices.

Development Information

Same series standard

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