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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
Hardcopy , PDF
10-09-2018
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.
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
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