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 11137-2:2013

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

May 21, 2013

General information

90.92     Jul 23, 2024

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

Buying

Published

Language in which you want to receive the document.

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

WITHDRAWN
ISO 11137-2:2012

NOW

PUBLISHED
ISO 11137-2:2013
90.92 Standard to be revised
Jul 23, 2024

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11137-2:2013/Amd 1:2022

REVISED BY

PROJECT
ISO/CD 11137-2

National adoptions

SRPS EN ISO 11137-2:2014  
ISS

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

95.99   Withdrawal of Standard

Z076 more

SRPS EN ISO 11137-2:2016  
ISS

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

60.60   Standard published

Z076 more