BAS EN ISO 17665-1:2008
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
General Information
Status: Published
No. of pages: 41
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 21.07.2008
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
saturated steam venting systems;
saturated steam active air removal systems;
air steam mixtures;
water spray;
water immersion.
Lifecycle
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Original document and degree of correspondence
- EN ISO 17665-1:2006, identical
- ISO 17665-1:2006, identical