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ISO 11135:2014
New product
ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesMore info
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.
| Author | ISO/TC 198 Sterilization of health care products |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 2 |
| ICS | 11.080.01 : Sterilization and disinfection in general
|
| Number of pages | 78 |
| Replace | ISO 11135-1:2007 ISO/TS 11135-2:2008 |
| Modified by | ISO 11135:2014/Amd 1:2018
|
| Weight(kg.) | 0.2326 |
| Year | 2014 |
| Country | Switzerland |