SRPS EN ISO 15883-4:2011

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

Scope

ISO 15883-4:2008 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
ISO 15883-4:2008 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.
ISO 15883-4:2008 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.