16/30330536 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
Hardcopy , PDF
English
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 |
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