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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Amended by

ISO 11137-2:2013/Amd 1:2022

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

21-05-2013

Publisher

International Organization for Standardization

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$480.15

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Summarise this standard

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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.

Committee	ISO/TC 198
DevelopmentNote	Together with ISO 11137-1 and ISO 11137-3, Supersedes ISO 11137. (05/2006) Supersedes ISO/DIS 11137-2. (05/2013)
DocumentType	Standard
Pages	71
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11137-2:2012 ISO 11137:1995

Standards	Relationship
DS EN ISO 11137-2 : 2015	Identical
ÖNORM EN ISO 11137-2:2023 10 01	Identical
BS EN ISO 11137-2:2015	Identical
AAMI ISO 11137-2 : 2013	Identical
EN ISO 11137-2:2015	Identical
PN EN ISO 11137-2 : 2015	Identical
SS-EN ISO 11137-2:2015	Identical
GOST ISO 11137-2 : 2011	Identical
NF EN ISO 11137-2 : 2015	Identical
NBN EN ISO 11137-2 : 2015	Identical
NEN EN ISO 11137-2 : 2015	Identical
NS EN ISO 11137-2 : 2015	Identical
I.S. EN ISO 11137-2:2015	Identical
BS EN ISO 11137-2:2013	Equivalent
I.S. EN ISO 11137-2:2013	Equivalent
DIN EN ISO 11137-2:2013-09	Equivalent
DIN EN ISO 11137-2:2015-11	Identical
GOST R ISO 11137-2 : 2008	Identical
UNE-EN ISO 11137-2:2013	Identical
UNE-EN ISO 11137-2:2015	Identical
ANSI/AAMI/ ISO 11137-2:2013(R2019)	Identical
BS EN ISO 11137-2:2013	Identical

Frequently Asked Questions

ISO 11137-2 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. In practice it is applied by healthcare product manufacturers and sterilisation providers using ionising radiation.

ISO 11137-2 is International Organization for Standardization (ISO)'s standard for radiation sterilisation of healthcare products, while ISO 11135 covers ethylene oxide sterilisation of healthcare products (International). ISO 11137-2 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes.

ISO 11137-2 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11137-2 is used by healthcare product manufacturers and sterilisation providers using ionising radiation. It is an international standard published by International Organization for Standardization (ISO).

ISO 11137-2 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. It is an international standard published by International Organization for Standardization (ISO).

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ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

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