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Norm
ISO 11137:1995
Issue date: 1995 03 09
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type...
Withdrawn: 2006 04 19
Publisher:
International Organization for Standardization
Format:
Digital | 61 Pages
Language:
English
Currently valid:
ICS
Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.
ISO 11137-3:2017
2017 06 26
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of develo...
Norm
ISO 11137-2:2013
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 11137-2:2012
2012 03 15
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 11137-3:2006
2006 04 19
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
Norm
ISO 11137-1:2006
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation...
Norm
ISO 11137-2:2006
2006 04 19
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (Cor...
Norm
ISO 11137:1995
1995 03 09
Sterilization of health care products — Requirements for validation and routine control — Radiation ...
Norm
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Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (Corrected version 2006-07)
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
