ISO 11135:2014 Preview

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 industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

General information ^

Status : Published

Publication date : 2014-07
Edition : 2

Number of pages : 78
Technical Committee
:
ISO/TC 198

Sterilization of health care products
ICS :

11.080.01

Sterilization and disinfection in general

This standard contributes to the following Sustainable Development Goal:

Good Health and Well-being

Buy this standard

	Format	Language
std 1 178	PDF
std 2 178	Paper

CHF178

Life cycle

A standard is reviewed every 5 years

Revisions / Corrigenda

Previously
ISO 11135-1:2007
ISO/TS 11135-2:2008
Now under review
ISO 11135:2014
Corrigenda/Amendments
ISO 11135:2014/Amd 1:2018

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