EN ISO 11137-2:2007

Name: EN ISO 11137-2:2007
Brand: CEN
SKU: EN ISO 11137-2:2007
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) EN ISO 11137-2:2007

Publication date: Aug 21, 2009

General information

Current stage: 99.60 Withdrawal effective Mar 15, 2012

Originator: CEN

Owner: CEN/TC 204 Sterilization of medical devices

Type: European Norm

ICS: 11.080.01 Sterilization and disinfection in general

Buying

Status: Withdrawn

Scope

ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting

93/42/EEC

Medical devices

Harmonized/Supporting

PREVIOUSLY

WITHDRAWN
EN ISO 11137-2:2006

NOW

WITHDRAWN
EN ISO 11137-2:2007
99.60 Withdrawal effective
Mar 15, 2012

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 11137-2:2007/AC:2009

REVISED BY

WITHDRAWN
EN ISO 11137-2:2012