0 Items
My account
Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO 11137-2:2006

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

Apr 19, 2006
95.99   Withdrawal of Standard   Mar 15, 2012

General information

95.99     Mar 15, 2012

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11137:1995

WITHDRAWN
ISO 11137:1995/Cor 1:1997

WITHDRAWN
ISO 11137:1995/Amd 1:2001

NOW

WITHDRAWN
ISO 11137-2:2006
95.99 Withdrawal of Standard
Mar 15, 2012

CORRIGENDA / AMENDMENTS

ABANDON
ISO 11137-2:2006/PWI Amd 1

WITHDRAWN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

REVISED BY

WITHDRAWN
ISO 11137-2:2012

National adoptions

SRPS EN ISO 11137-2:2008  
ISS

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

95.99   Withdrawal of Standard

Z076 more