EN ISO 15883-5 Washer-Disinfectors - Part 5: Performance Requirements and Test Method Criteria for Demonstrating Cleaning Efficiency

Medical Device Tests

EN ISO 15883-5 Washer-Disinfectors - Part 5: Performance Requirements and Test Method Criteria for Demonstrating Cleaning Efficiency

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 15883-5 testing. This standard specifies the procedures and test methods used to demonstrate the cleaning effectiveness of washer-disinfectors (WD) and accessories intended for use in cleaning reusable medical devices.

EN ISO 15883-5 Washer-Disinfectors - Part 5: Performance Requirements and Test Method Criteria for Demonstrating Cleaning Efficiency

Testing cleaning effectiveness is an important aspect of ensuring satisfactory performance of a washer-disinfector (WD). This test includes type testing under simulated conditions of use. In addition to type testing, performance adequacy testing is performed under clinical use conditions.

The cleaning efficiency of washer-disinfectors has historically been proven with reference to different test soils and methods that have been used in several different countries. This standard gives requirements for standardized methods for demonstrating cleaning efficacy, including test stain samples. Individual requirements for various washer-disinfector types and handling procedures may vary, but this document provides the basis for demonstrating cleaning effectiveness.

The rationale for choosing the test soil and staining methods should be justified and documented. Test soil formulations can be selected or developed based on a review of the literature and demonstration of suitability based on the use of the medical device/product in clinical practice.

EUROLAB assists manufacturers with EN ISO 15883-5 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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