ISO 11137-2:2012

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

Publication date: 15 mar 2012

95.99 Withdrawal of Standard 21 maj 2013

General information

Current stage: 95.99 Effective date: 21 maj 2013

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Gjuha: anglisht frëngjisht

Buying

Statusi: Shfuqizuar

PDF - 7 350 Lekë

Paper - 7 350 Lekë

CD - 7 350 Lekë

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11137-2:2006

WITHDRAWN
ISO 11137-2:2006/Cor 1:2009

NOW

WITHDRAWN
ISO 11137-2:2012
95.99 Withdrawal of Standard
21 maj 2013

REVISED BY

PUBLISHED
ISO 11137-2:2013