T/CAMDI 056-2020 Management specification for ethylene oxide sterilization process of sterile medical devices

Scope

Main technical content: This document sets out clear requirements and guidance for the control of the ethylene oxide sterilization production process from the aspects of quality management system, safety and environmental protection, sterilization process control and monitoring, change and non-conformance control, and re-sterilization. It is designed to guide manufacturers of self-sterilized medical devices and subcontracted sterilization companies in standardizing the management of the ethylene oxide sterilization process. Except for the scope of application, normative reference documents, terms and definitions, and references, the main content of the other parts of this specification is summarized as follows: 1) Quality management system: Requirements and guidance are provided for enterprises (manufacturers and subcontracted sterilization companies) in terms of quality management system, document requirements, management responsibilities, personnel and equipment, and procurement. 2) Safety and environmental protection: Requirements and guidance are provided for fire safety, personnel safety, process safety, and environmental protection. 3) Sterilization process and monitoring: Requirements and guidance are provided for activities such as product reception and storage, sterilization process, post-sterilization storage, sterilization release, and shipping/transfer during the sterilization process. 4) Change and non-conformance control: Requirements are provided for change and non-conformance control during the sterilization process. 5) Requirements for re-sterilization processes. Through the requirements and guidance in the above-mentioned sections, this standard specification document serves as a good supplement to the implementation of GB18279.1 and GB/T18279.2. At the same time, it makes the daily process control of ethylene oxide sterilization more executable and operable, thereby ensuring the effectiveness and safety of the sterilization process con

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