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EN 1174-3:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques EN 1174-3:1996

Publication date:   Nov 20, 2003

General information

99.60 Withdrawal effective   Apr 1, 2006

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

07.100.10   Medical microbiology | 11.080   Sterilization and disinfection

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Scope

This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation. This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given. This document is informative and does not contain requirements.

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

NOW

WITHDRAWN
EN 1174-3:1996
99.60 Withdrawal effective
Apr 1, 2006

REVISED BY

WITHDRAWN
EN ISO 11737-1:2006