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SSH EN ISO 11137-2:2012

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

Sep 26, 2012
95.99 Withdrawal of Standard   May 6, 2014

General information

95.99     May 6, 2014

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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Scope

ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN ISO 11137-2:2012
95.99 Withdrawal of Standard
May 6, 2014

REVISED BY

WITHDRAWN
SSH EN ISO 11137-2:2013

Related project

Adopted from EN ISO 11137-2:2012