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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...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 52 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
Committee 215: Sterilization and disinfection of medical devices
ICS
11.080.01
Topics
Healthcare, Sterilization and disinfection of medical devices, Sterilization and disinfection in general
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
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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
Historie aufklappen
Norm
ISO 11137-1:2006
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
ISO 11137-2:2013
Issue date : 2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Technische Regel
ISO/TS 13004:2013
Issue date : 2013 05 06
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Norm
ISO 13485:2016
Issue date : 2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 11137-3:2017
Issue date : 2017 06 26
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control