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EVS-EN ISO 15883-4:2009

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

General information
Withdrawn from 03.01.2019
Base Documents
ISO 15883-4:2008; EN ISO 15883-4:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history
Status
Date
Type
Name
03.01.2019
Main
03.12.2009
Main
Main
EVS-EN ISO 15883-4:2008
This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) 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. 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 re-validation, periodically and after essential repairs, are also specified.
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Standard monitoring
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