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ISO 11135:2014

ISO 11135:2014

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Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Amended by

ISO 11135:2014/Amd 1:2018

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

07-07-2014

Publisher

International Organization for Standardization

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£209.00
Excluding VAT
Summarise this standard

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.

Committee
ISO/TC 198
DevelopmentNote
Supersedes ISO/DIS 11135, ISO 11135-1 and ISO TS 11135-2. (07/2014)
DocumentType
Standard
Pages
78
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Frequently Asked Questions

ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. It is an international standard published by International Organization for Standardization (ISO).

ISO 11135 is used by medical device manufacturers and sterilisation service providers using ethylene oxide. It is an international standard published by International Organization for Standardization (ISO).

ISO 11135 is International Organization for Standardization (ISO)'s standard for ethylene oxide sterilisation of healthcare products, while ISO 11137-1 covers radiation sterilisation of healthcare products (International). ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

ISO 11135 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. In practice it is applied by medical device manufacturers and sterilisation service providers using ethylene oxide.
£209.00
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Hardcopy - French
PDF - French
Hardcopy - English
PDF - English
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