T/CAMDI 157.1-2025 Active Group standards

T/CAMDI 157.1-2025 Guidance on the sterilization compatibility of polymer and packaging materials for medical devices?—?Part 1：General requirements

Publish Date: 2025-12-22 Implement Date: 2025-12-22 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CAMDI 157.1-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2025-12-22

Implement Date: 2025-12-22

Scope

This document provides general guidelines and factors to consider for the sterilization compatibility of polymer materials and packaging materials used in medical devices. This document applies to polymer materials and packaging materials used in medical devices that are sterilized using the following methods: a) Ethylene oxide sterilization. b) Gamma radiation sterilization. c) Electron beam sterilization. d) X-ray sterilization. e) Moist heat (steam) sterilization. f) Moist heat in a non-air permeable package. g) Dry heat sterilization. h) Vaporized hydrogen peroxide plasma sterilization. i) Chlorine dioxide sterilization. j) Nitrogen dioxide sterilization. k) Peracetic acid vapor sterilization. l) Liquid peracetic acid sterilization. m) Hydrogen peroxide-ozone sterilization. n) Low-temperature steam formaldehyde sterilization. Note: The data provided in this document cannot be used as a basis for material verification. This information is general and serves only as a guide for initiating a material qualification program.