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STANDARD

Current

ÖNORM EN ISO 11137-2

Issue date: 2023 10 01

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Document Number Title
Document Number
ÖNORM EN ISO 11137-2/A1
Title
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013/Amd 1:2022) (Amendment)
This part of ISO 11137 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). This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
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General information on ÖNORM EN ISO 11137-2

Format
Paper | 90 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International
Committee 215 Sterilization and disinfection of medical devices

Timeline

An overview of the development of ÖNORM EN ISO 11137-2 from 1994 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art
Dokumentnummer
ISO 11137-1:2006
Titel
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Ausgabedatum
2006 04 19
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 11737-1:2018
Titel
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Ausgabedatum
2018 01 12
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 11737-2:2019
Titel
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Ausgabedatum
2019 12 02
Art
Standard
Zur Produktseite

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