I.S. EN ISO 18472:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
Hardcopy , PDF
09-10-2018
English
01-01-2006
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements for resistometers
4.1 Intended use
4.2 Measurement and control capabilities
4.3 Test methods
4.4 Leak test
4.5 Steam resistometer performance requirements
4.6 Ethylene oxide resistometer performance requirements
4.7 Dry heat (heated air) resistometer performance
requirements
4.8 Vaporized hydrogen peroxide process resistometer
performance requirements
5 Recording systems
5.1 Measurement systems
5.2 Calibration
6 Documentation
6.1 General
6.2 Minimum information
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
Specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators.
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN ISO 18472 : 2006 | Identical |
| BS EN ISO 18472:2006 | Identical |
| DIN EN ISO 18472:2006-10 | Identical |
| ISO 18472:2006 | Identical |
| NS EN ISO 18472 : 1ED 2006 | Identical |
| SN EN ISO 18472 : 2006 | Identical |
| NEN EN ISO 18472 : 2006 | Identical |
| ONORM EN ISO 18472 : 2006 | Identical |
| NF EN ISO 18472 : 2006 | Identical |
| EN ISO 18472:2006 | Identical |
| UNI EN ISO 18472 : 2006 | Identical |
| UNE-EN ISO 18472:2007 | Identical |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| ISO 10013:1995 | Guidelines for developing quality manuals |
| 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 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 |
| 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 |
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