BS EN 16442:2015
Current
The latest, up-to-date edition.
Controlled environment storage cabinet for processed thermolabile endoscopes
Hardcopy , PDF
English
31-03-2015
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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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