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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

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Kehtiv alates 19.04.2006
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
08.11.2018
Muudatus
16.07.2013
Muudatus
19.04.2006
Põhitekst
Põhitekst
ISO 11137:1995
Parandus
ISO 11137:1995/Cor 1:1997
Muudatus
ISO 11137:1995/Amd 1:2001
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.
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Teised on ostnud veel

Muudatus

ISO 11137-1:2006/Amd 1:2013

ISO 11137-1:2006 - Amendment
Uusim versioon Kehtiv alates 16.07.2013
Põhitekst

ISO 11137-2:2013

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
Uusim versioon Kehtiv alates 21.05.2013
Muudatus

ISO 11137-1:2006/Amd 2:2018

Revision to 4.3.4 and 11.2
Uusim versioon Kehtiv alates 08.11.2018
Põhitekst

ISO 11737-2:2019

Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Uusim versioon Kehtiv alates 02.12.2019