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Norm
ISO 11135:2014
Issue date: 2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the indus...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 78 Pages
Language:
English
ICS
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
ISO 11135:2014
2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validatio...
Norm
↖
ISO/TS 11135-2:2008
2008 07 17
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO ...
Technische Regel
ISO 11135-1:2007
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, valid...
Norm
ISO 11135:1994/Cor 1:1994
1994 10 27
Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrige...
Norm
ISO 11135:1994
1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Norm
Norm
Issue date :
2018 10 15
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release