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Norm
ÖNORM EN ISO 11137-1
Issue date: 2006 07 01
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)
1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Alt...
Withdrawn: 2013 12 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 46 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other products and equipment.
This part of ISO 11137 covers radiation processes employing irradiators using,
a) the radionuclide 60Co or 137Cs,
b) a beam from an electron generator
or
c) a beam from an X-ray generator.
1.2 This part of ISO 11137 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 Creutzfeld-Jakob disease. Specific recommendations have been produced in
particular countries for the processing of materials potentially contaminated with these agents.
NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.1 This part of ISO 11137 does not detail specified requirements for designating a medical device as
sterile.
NOTE Attention is drawn to regional and national requirements for designating medical devices as ¿sterile.¿ See, for
example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This part of ISO 11137 does not specify a quality management system for the control of all stages of
production of medical devices.
NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during
manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization
process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the
standards for quality management systems (see ISO 13485) that control all stages of production of medical devices,
including the sterilization process. Regional and national regulations for the provision of medical devices might require
implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This part of ISO 11137 does not require that biological indicators be used for validation or monitoring
of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product
release.
ISO 11137-1:2006(E)
2 © ISO 2006 ¿ All rights reserved
1.2.4 This part of ISO 11137 does not specify requirements for occupational safety associated with the
design and operation of irradiation facilities.
NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for
occupational safety related to radiation.
1.2.5 This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed
devices.
ÖNORM EN ISO 11137-1
2020 04 01
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
Norm
ÖNORM EN ISO 11137-1
2015 11 15
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
Norm
ÖNORM EN ISO 11137-1
2013 12 15
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
Norm
ÖNORM EN ISO 11137-1
2006 07 01
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
Norm
↖
ÖNORM EN 552/A2
2001 03 01
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (A...
Norm
ÖNORM EN 552/A1
1999 10 01
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (A...
Norm
ÖNORM EN 552
1994 09 01
Sterilization of medical devices - Validation and routine control of sterilization irradiation
Norm
Norm
Issue date :
2006 03 20
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Corrected version 2006-03)
Norm
Issue date :
2009 11 06
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (Corrected version 2006-07)
Norm
Issue date :
2018 01 12
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Norm
Issue date :
2019 12 02
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Norm
Issue date :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
Issue date :
2013 12 15
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 + Amd 1:2013) (consolidated version)
Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices