International Organization for Standardization

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
 N DIS 15883-4

Annotation

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.