EN ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 16
- Дата публикации:
- 29 марта 2017 г.
- Издание:
- CEN EN 11138 edition 2 version 1
- ICS:
- 11.080.01
2016-12-13: Decision 458 on de-harmonization of EN ISO 11138 series taken on 2016-12-09.
Abstract
Overview
EN ISO 11138-4:2017 - "Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes" - specifies production, test methods and performance requirements for biological indicators (BIs) used to validate and monitor (120 °C to 180 °C). Adopted by CEN as EN , this edition supersedes the 2006 version and provides updated criteria for BI manufacture, resistance characterization and packaging suitability.
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