BSI DD CEN ISO/TS 17665-2:2009
$198.66
Sterilization of health care products. Moist heat – Guidance on the application of ISO 17665-1
Published By | Publication Date | Number of Pages |
BSI | 2009 | 56 |
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.