SS-EN-ISO-15883-2 › Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaestetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
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This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. 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 2 If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.
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Medical devices. Revised Machinery Directive
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SS-EN ISO 15883-2:2009
June 15, 2009
EN ISO 15883-2:2009(IDT); ISO 15883-2:2006(IDT)