Sterilization of health care products. Moist heat -- Guidance on the application of ISO 17665-1
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.
NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E.
NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.
| SDO | BSI: British Standards Institution |
| Document Number | CISO/TS 17665-2 |
| Publication Date | Feb. 28, 2009 |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | CH/198 |
Failed to load document history.
| Publish Date | Document Id | Type | View |
|---|