Phone: +1 758-453-0049
E-mail: info@slbs.org
Bisee, Saint Lucia LC04301

ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Apr 19, 2006

General information

90.92     Sep 8, 2020

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.

Life cycle

NOW

PUBLISHED
ISO 11137-1:2006
90.92 Standard to be revised
Sep 8, 2020

CORRIGENDA / AMENDMENTS

Amended by
ISO 11137-1:2006/Amd 1:2013

Amended by
ISO 11137-1:2006/Amd 2:2018

REVISED BY

ABANDON
ISO/NP 11137-1

IN_DEVELOPMENT
ISO/DIS 11137-1

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.

Login