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EN ISO 11137-2:2012

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

Publication date:   May 17, 2012

General information

99.60 Withdrawal effective   Jun 5, 2013

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

ISO 11137-2:2011 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 legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11137-2:2007

WITHDRAWN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

NOW

WITHDRAWN
EN ISO 11137-2:2012
99.60 Withdrawal effective
Jun 5, 2013

REVISED BY

WITHDRAWN
EN ISO 11137-2:2013