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I.S. EN 16442:2015

Current
Current

The latest, up-to-date edition.

CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Preview

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

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

DocumentType
Standard
Pages
62
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 16442:2015 Identical

ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
EN 60751:2008 INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS

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