ISO 11607-2:2019/Amd 1:2023
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 6
- Дата публикации:
- 13 сентября 2023 г.
- Издание:
- ISO IS 11607 edition 2 version 1
- ICS:
- 11.080.30
Abstract
Overview
ISO 11607-2:2019/Amd 1:2023 is an important amendment to the international standard ISO 11607-2:2019, which specifies the validation requirements for forming, sealing, and assembly processes involved in packaging for terminally sterilized medical devices. This 2023 amendment integrates the into the framework, emphasizing a structured approach to identifying, evaluating, and controlling risks related to packaging processes.
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