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CEN ISO/TS 17665-2

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

active, Most Current
Organization: CEN
Publication Date: 1 January 2009
Status: active
Page Count: 56
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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.

Document History

CEN ISO/TS 17665-2
January 1, 2009
Sterilization of health care products - Moist heat - Part 2: 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...

References

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