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CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-2015
Publisher: National Standards Authority of Ireland
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.Dates of withdrawal of national standards are available from NSAI.
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Performance requirements5 Mechanical and procedure requirements6 Testing for conformity7 Documentation8 Information to be supplied with the storage cabinet9 Information to be requested from the purchaser by the manufacturerAnnex A (informative) - Summary of test programmesAnnex B (informative) - Cross-contamination between endoscopesAnnex C (normative) - Methods for evaluation of airborne microbial contamination in the storage cabinetAnnex D (informative) - Procedure for parametric performance qualificationAnnex E (normative) - Internal residual contamination of endoscopes after storageAnnex F (normative) - Establishing endoscope type test groupsAnnex G (normative) - Establishing endoscope product familiesBibliography
Defines the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.
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