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SRPS EN ISO 11137-2:2016

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

Oct 31, 2016

General information

60.60     Oct 31, 2016

ISS

Z076

European Norm

11.080.01  

English  

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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

Directives related to this standard.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized
Directive 2017/745
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized
Directive 2017/746

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11137-2:2014

NOW

PUBLISHED
SRPS EN ISO 11137-2:2016
60.60 Standard published
Oct 31, 2016

REVISED BY

PROJECT
prSRPS EN ISO 11137-2:2024

Related project

Adopted from EN ISO 11137-2:2015

Adopted from ISO 11137-2:2013 IDENTICAL