BAS EN 867-2:2003
Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
General Information
Status: Withdrawn
No. of pages: 12
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 18.11.2003
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN 867-2:1997, identical