BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements for resistometers
5 Calibration
Annex A (informative) - Additional performance
        characterization - Steam
Annex B (informative) - Additional performance
        characterization - Ethylene oxide
Annex C (informative) - Additional performance
        characterization - Dry heat
Annex D (informative) - Resistometer documentation
        and derivations
Bibliography

BS EN ISO 18472.

Committee	CH/198
DocumentType	Draft
Pages	37
PublisherName	British Standards Institution
Status	NA

ISO 11138-3:2017	Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11140-3:2007	Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11138-2:2017	Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 11140-4:2007	Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO/TR 10013:2001	Guidelines for quality management system documentation
IEC 60751:2008	Industrial platinum resistance thermometers and platinum temperature sensors
ISO 11140-5:2007	Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 11138-4:2017	Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2017	Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices