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Norm
ISO 11135:1994
Issue date: 1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general req...
Withdrawn: 2008 07 17
Publisher:
International Organization for Standardization
Format:
Digital | 24 Pages
Language:
English
Currently valid:
ICS
Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.
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
1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Norm
↖
Technische Regel
Issue date :
2008 07 17
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
Norm
Issue date :
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
