I.S. EN 16442:2015
Current
The latest, up-to-date edition.
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
Hardcopy , PDF
English
01-01-2015
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
5 Mechanical and procedure requirements
6 Testing for conformity
7 Documentation
8 Information to be supplied with the storage cabinet
9 Information to be requested from the purchaser by the
manufacturer
Annex A (informative) - Summary of test programmes
Annex B (informative) - Cross-contamination between endoscopes
Annex C (normative) - Methods for evaluation of airborne microbial
contamination in the storage cabinet
Annex D (informative) - Procedure for parametric performance
qualification
Annex E (normative) - Internal residual contamination of endoscopes
after storage
Annex F (normative) - Establishing endoscope type test groups
Annex G (normative) - Establishing endoscope product families
Bibliography
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