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EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Jan 31, 2018

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

07.100.10   Medical microbiology | 11.080.01   Sterilization and disinfection in general

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Scope

ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

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WITHDRAWN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 1174-1:1996

WITHDRAWN
EN 1174-2:1996

WITHDRAWN
EN 1174-3:1996

NOW

WITHDRAWN
EN ISO 11737-1:2006
99.60 Withdrawal effective
Jan 31, 2018

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 11737-1:2006/AC:2009

REVISED BY

PUBLISHED
EN ISO 11737-1:2018