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SRPS EN ISO 11137-2:2014

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Jan 31, 2014
95.99   Withdrawal of Standard   Oct 31, 2016

General information

95.99     Oct 31, 2016

ISS

Z076

European Norm

11.080.01  

English  

From plan 2013

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Scope

ISO 11137-2:2013 specifies methods for 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 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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

Harmonized
93/42/EEC

Medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11137-2:2011

NOW

WITHDRAWN
SRPS EN ISO 11137-2:2014
95.99 Withdrawal of Standard
Oct 31, 2016

REVISED BY

PUBLISHED
SRPS EN ISO 11137-2:2016

Related project

Adopted from EN ISO 11137-2:2013

Adopted from ISO 11137-2:2013 IDENTICAL