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)

There are 1 addition(s) to this standard

Document Number	Title	Link
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

Digital | 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.

• ÖNORM EN ISO 11137-2

  2023 10 01 Standard ÖNORM EN ISO 11137-2, Edition: 2023 10 01

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN ISO 11137-2

  2015 10 15 Standard ÖNORM EN ISO 11137-2, Edition: 2015 10 15

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN ISO 11137-2

  2013 09 15 Standard ÖNORM EN ISO 11137-2, Edition: 2013 09 15

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN ISO 11137-2

  2012 06 01 Standard ÖNORM EN ISO 11137-2, Edition: 2012 06 01

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN ISO 11137-2

  2007 10 01 Standard ÖNORM EN ISO 11137-2, Edition: 2007 10 01

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN ISO 11137-2

  2006 07 01 Standard ÖNORM EN ISO 11137-2, Edition: 2006 07 01

  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
• ÖNORM EN 552/A2

  2001 03 01 Standard ÖNORM EN 552/A2, Edition: 2001 03 01

  Sterilization of medical devices - Validation and routine control of sterilization by irradiation (A...
• ÖNORM EN 552/A1

  1999 10 01 Standard ÖNORM EN 552/A1, Edition: 1999 10 01

  Sterilization of medical devices - Validation and routine control of sterilization by irradiation (A...
• ÖNORM EN 552

  1994 09 01 Standard ÖNORM EN 552, Edition: 1994 09 01

  Sterilization of medical devices - Validation and routine control of sterilization irradiation

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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	Link
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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