ISO 11135-1:2007
Withdrawn
View Superseded by
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Hardcopy , PDF
English, French, Russian
04-27-2007
02-16-2019
ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11135-1. (04/2007)
|
| DocumentType |
Standard
|
| Pages |
41
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11135-1 : 2007 | Identical |
| NBN EN ISO 11135-1 : 2007 | Identical |
| NEN EN ISO 11135-1 : 2007 | Identical |
| NS EN ISO 11135-1 : 1ED 2007 | Identical |
| I.S. EN ISO 11135-1:2007 | Identical |
| PN EN ISO 11135-1 : 2009 | Identical |
| SAC GB 18279.1 : 2015 | Identical |
| BS EN ISO 11135-1:2007 | Identical |
| AAMI ISO 11135-1 : 2007 | Identical |
| EN ISO 11135-1:2007 | Identical |
| DIN EN ISO 11135-1:2007-08 | Identical |
| JIS T 0801-1:2010 | Identical |
| DIN EN ISO 11135-1:2007-08 | Equivalent |
| UNE-EN ISO 11135-1:2007 | Identical |
A newer version of this standard is available.
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