PD ISO/TS 21387:2020 PDF
Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 сентября 2020 г.
- ICS:
- 11.080.01
- SKU:
- PD ISO/TS 21387:2020
Abstract
What is ISO/TS 21387 about ?
ISO/TS 21387 in an international standard which discusses about requirements and routine processer for sterilization of medical devices. ISO/TS 21387 provides guidance on the requirements that apply when parametric release is used to release the product after exposure to the sterilization process. ISO/TS 21387 provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle.
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