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BS 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

03-31-2015

US$359.44
Excluding Tax where applicable

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.

Committee
CH/198
DevelopmentNote
Supersedes 12/30248648 DC. (03/2015)
DocumentType
Standard
Pages
64
PublisherName
British Standards Institution
Status
Current
Supersedes

This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing. The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels. The controlled environment provided by the storage cabinet ensures that during storage there is no deterioration of the microbiological quality of the endoscope. The drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle. This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air. NOTE 1 The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use. NOTE 2 Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes. The cabinet is not intended to provide any cleaning or disinfection function. This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage

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 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 (ISO 14644-3:2005)

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