ISO 11137-2:2013

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

Publication date: May 21, 2013

General information

Current stage: 90.93 Effective date: Oct 23, 2018

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: English French

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Status: Published

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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.

Life cycle

PREVIOUSLY

Revises
ISO 11137-2:2012

NOW

PUBLISHED
ISO 11137-2:2013
90.93 Standard confirmed
Oct 23, 2018

CORRIGENDA / AMENDMENTS

Amended by
ISO 11137-2:2013/Amd 1:2022

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