ISO 15883-1 specifies general performance requirements for washer-disinfectors (WD) and washer-disinfectors 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.
The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
ISO 15883-1 does not specify requirements intended for machines for use in laundry or general catering purposes. ISO 15883-1 does not include requirements for machines that are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards. The specified performance requirements of this document do not ensure the inactivation or removal of the causative agents (prion protein) of transmissible spongiform encephalopathies.
Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
ISO 15883-1 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. 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 WD throughout its service life. Guidance on a routine test programme is given in Annex A.
ISO 15883-1:2024 text has been approved in Europe as EN ISO 15883-1:2025 without any changes.
