SS ISO 11135:2019
Sterilisation of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilisation process for medical devices
OVERVIEW
Specifies requirements for the development, validation and routine control of an ethylene oxide sterilisation process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
Does not cover / specify the following:
- requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
- a specified requirement for designating a medical device as sterile.
- a quality management system for the control of all stages of production of medical devices.
- requirements for occupational safety associated with the design and operation of EO sterilization facilities.
- sterilisation by injecting EO or mixtures containing EO directly into packages or a flexible chamber.
- analytical methods for determining levels of residual EO and/or its reaction products.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2019 |
| No. of Pages | 99 |
| ICS Classification | 11.080.01 Sterilization and disinfection in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11135 : 2014 +A1 : IDT |