DANSK DSF/FPREN ISO 15883-4 PDF

This part of ISO 15883 specifies the particular requirements, including performance criteria for washerdisinfectors (WD) 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 criteria. 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 requalification of WDs periodically and after essential repairs, are also specified. NOTE 1 – In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this part of ISO 15883. NOTE 2 – WD complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfection of medical devices, including endoscopic 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 ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 – If it is considered that prion protein might 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 and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 – This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.