prEN ISO 15883-1

This document specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified. NOTE 1 The requirements can be applied to washer-disinfectors intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice. The requirements for washer-disinfectors intended to process specific loads are specified in other parts of the ISO 15883 series. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of the ISO 15883 series apply. This document does not specify requirements intended for machines for use for laundry or general catering purposes. This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers”, these are specified in other standards, e.g. EN 285[21]. The specified performance requirements of this standard do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that prion protein can be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein in a manner that can inhibit its removal or inactivation. This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a washer-disinfector. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed washer-disinfector throughout its service life. Guidance on a routine test programme is given in Annex A.