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Norm
ÖNORM EN ISO 11137-3
Issue date: 2017 11 01
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation a...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 52 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
ÖNORM EN ISO 11137-3
2017 11 01
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of develo...
Norm
↖
ÖNORM EN ISO 11137-3
2006 07 01
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 1113...
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
Technische Regel
Issue date :
2013 05 06
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Norm
Issue date :
2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
Issue date :
2017 06 26
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
