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ISO 11137-2:2013

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

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Kehtiv alates 21.05.2013
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
13.06.2022
Muudatus
21.05.2013
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Põhitekst
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.

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ISO 11137-3:2017

Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control
Uusim versioon Kehtiv alates 26.06.2017
Muudatus

ISO 11137-1:2006/Amd 2:2018

Revision to 4.3.4 and 11.2
Uusim versioon Kehtiv alates 08.11.2018
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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
Uusim versioon Kehtiv alates 19.04.2006
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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