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BS EN 16442 : 2015

M00017532

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BS EN 16442 : 2015

CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Performance requirements<br>5 Mechanical and procedure requirements<br>6 Testing for conformity<br>7 Documentation<br>8 Information to be supplied with the storage cabinet<br>9 Information to be requested from the purchaser by the<br>&nbsp;&nbsp;manufacturer<br>Annex A (informative) - Summary of test programmes<br>Annex B (informative) - Cross-contamination between endoscopes<br>Annex C (normative) - Methods for evaluation of airborne microbial<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination in the storage cabinet<br>Annex D (informative) - Procedure for parametric performance<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;qualification<br>Annex E (normative) - Internal residual contamination of endoscopes<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;after storage<br>Annex F (normative) - Establishing endoscope type test groups<br>Annex G (normative) - Establishing endoscope product families<br>Bibliography

Abstract

Defines the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/198
Supersedes
  • 12/30248648 DC : DRAFT AUG 2012