T/CAMDI 058-2025 Final sterilization of medical device packaging - Application guide for GB/T 19633.1 and GB/T 19633.2

Scope

Main technical content: This document provides guidance for applying the relevant requirements of GB/T 19633.1 and GB/T 19633.2, without adding or otherwise modifying the requirements of GB/T 19633.1 and GB/T 19633.2. This document can be used to better understand the requirements of GB/T 19633.1 and GB/T 19633.2, and illustrates various methods and approaches to meet these standard requirements. It is not required to use this document to demonstrate compliance with these regulations. This document provides guidelines for the evaluation, selection, and use of packaging materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. It also provides guidelines for the requirements of confirming the molding, sealing, and assembly processes. This document provides information for medical institutions and the medical device industry that provide final sterilized medical devices. This document does not provide guidelines for the application of packaging materials and systems after opening. For packaging used for other purposes (for example, in "sterile zones" or for the transportation of contaminated items), please refer to relevant regulatory standards.

Development Information

Related Standards