scope:

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. This part of ISO 15883 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.