Norm

ISO/DIS 15883-4:2016 en

Desinfecterende wasmachines - Deel 4: Eisen en beproevingen voor desinfecterende wasmachines met chemische desinfectering voor temperatuurgevoelige endoscopen

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Over deze norm

Status Ontwerp
Aantal pagina's 78
Gepubliceerd op 05-05-2016
Taal Engels
This part of ISO 15883 specifies the particular requirements, including performance criteria for washerdisinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WDs periodically and after essential repairs, are also specified. WD complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006, 4.1.5). The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

Details

ICS-code 11.080.10
Nederlandse titel Desinfecterende wasmachines - Deel 4: Eisen en beproevingen voor desinfecterende wasmachines met chemische desinfectering voor temperatuurgevoelige endoscopen
Engelse titel Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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