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SRPS EN ISO 11137-2:2008

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

Mar 27, 2008
95.99   Withdrawal of Standard   Sep 30, 2011

General information

95.99     Sep 30, 2011

ISS

Z076

European Norm

11.080.01  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Directive 90/385/EEC
93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 11137-2:2008
95.99 Withdrawal of Standard
Sep 30, 2011

REVISED BY

WITHDRAWN
SRPS EN ISO 11137-2:2011

Related project

Adopted from EN ISO 11137-2:2006

Adopted from ISO 11137-2:2006 IDENTICAL