EN ISO 11137-1:2015

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015

Publication date:   Sep 16, 2015

General information

60.60 Standard published   Jun 10, 2015

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized/Supporting
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11137-1:2006/A1:2013

WITHDRAWN
EN ISO 11137-1:2006

NOW

PUBLISHED
EN ISO 11137-1:2015
60.60 Standard published
Jun 10, 2015

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 11137-1:2015/A2:2019

REVISED BY

IN_DEVELOPMENT
prEN ISO 11137-1

Relations

Adopted from ISO 11137-1:2006 IDENTICAL

Adopted from ISO 11137-1:2006/Amd 1:2013 IDENTICAL