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Norm
ÖNORM EN ISO 11137-2
Issue date: 2006 07 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified
requirement for sterility and methods to substantiate the use of 2...
Withdrawn: 2007 10 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 73 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 11137 specifies methods of 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 dose
auditing in order to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for dose establishment and dose auditing.
ÖNORM EN ISO 11137-2
2023 10 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
2015 10 15
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
2013 09 15
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
2012 06 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
2007 10 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
2006 07 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
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 :
1998 07 09
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
Draft
Issue date :
2007 12 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 :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
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
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 :
2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
Issue date :
2007 10 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (Corrected version 2006-07)
