EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 15883-4 testing. This standard specifies specific requirements, including performance criteria, for washer-disinfectors (WD) intended for cleaning and chemical disinfection of refractory endoscopes.
This standard also specifies the cleaning and disinfection performance requirements of the washer-disinfector and its components and accessories that may be required to achieve the required performance criteria.
Methods, instrumentation, and instructions are also outlined for type testing, walk testing, verification (installation, start-up, and performance qualification), routine inspection and monitoring, and requalification of WD periodically and after major repairs.
Complying with the requirements of this standard, WD is not intended for cleaning and disinfection of heat-resistant and thermally disinfectable or sterilizable medical devices, including endoscopic accessories.
The performance requirements specified in this standard do not guarantee inactivation or removal of the causative agents (prion protein) of infectious spongiform encephalopathies.
WD conforming to this standard can also be used for cleaning and chemical disinfection of other heat resistant reusable medical devices for which the device manufacturer has recommended and approved this disinfection method.
Given that prion protein may be present, special care should be taken in the selection of cleaning agents and disinfectants to ensure that the chemicals used do not react in a way that prevents them from reacting with the prion protein and/or other proteins.
EUROLAB assists manufacturers with EN ISO 15883-4 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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