EN 867-2:1997

Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Jul 15, 2005

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080   Sterilization and disinfection

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Scope

This part of EN 867 specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilisation process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 867-2:1997
99.60 Withdrawal effective
Jul 15, 2005

REVISED BY

WITHDRAWN
EN ISO 11140-1:2005