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EN ISO 17665-1:2006

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

Publication date:   Dec 27, 2006

General information

99.60 Withdrawal effective   May 1, 2024

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 554:1994

NOW

WITHDRAWN
EN ISO 17665-1:2006
99.60 Withdrawal effective
May 1, 2024

REVISED BY

PUBLISHED
EN ISO 17665:2024