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EN ISO 11137-2:2007

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

99.60 Withdrawal effective   Mar 15, 2012

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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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
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

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EN ISO 11137-2:2006

NOW

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

CORRIGENDA / AMENDMENTS

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EN ISO 11137-2:2007/AC:2009

REVISED BY

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EN ISO 11137-2:2012

Relations

Adopted from ISO 11137-2:2006 IDENTICAL