T/CAMDI 058-2020 Final sterilization of medical device packaging - Application guidelines 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 provides guidelines for evaluating, selecting, and using packaging materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. It also provides guidance on the requirements for confirming the molding, sealing, and assembly processes. Application guidelines are developed separately for medical institutions and the medical device industry, with 19 informative appendices providing detailed guidance: Appendix A: Selection, evaluation, and testing of packaging materials and sterile barrier systems; Appendix B: Sterilization precautions; Appendix C: Examples of packaging methods; Appendix D: Confirmation plan documents; Appendix E: Installation qualification documents; Appendix F: Operation qualification documents; Appendix G: Performance qualification documents; Appendix H: Requirements for worst-case scenarios; Appendix I: Establishing a final packaging system confirmation plan; Appendix J: Design input - medical device characteristics; Appendix K: Risk analysis tools; Appendix L: Sampling plan precautions; Appendix M: Stability tests; Appendix N: Internet applications; Appendix O: Guidelines for establishing process parameters; Appendix P: Use of contract packagers; Appendix Q: Guidelines for establishing process parameters; Appendix R: Investigating failures; Appendix S: Evaluation of the feasibility of packaging production processes and packaging system designs.

Development Information

Related Standards