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 disinfectio n of the washer-disinfector and its components and accessories which may be required to achieve the necessary perfohe 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 af ter essential repairs, are also specified. WDs complying with the requirements of this part of ISO 15883 are not intended fo r cleaning and disinfection of medical devices, including endo scopic 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 IS O 15883 may not ensure the inactivation or removal of the caus ative agent(s) (prion protein) of transmissible spongiform enc ephalopathies. This part of ISO 15883 can be used by prospecti ve purchasers and manufacturers as the basis of agreement on t he specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.