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Norm
ÖNORM EN ISO 11137-2
Issue date: 2015 10 15
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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 2...
Withdrawn: 2023 10 01
Publisher:
Austrian Standards International
Format:
Digital | 85 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
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
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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 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 :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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 :
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 :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
Issue date :
2023 10 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
