Performance testing methods, medical textiles

Hence this chapter mainly explains the medical textiles performance testing methods recommended in part 2 of EN 13795 e.g. 

Medical textiles are classified in Scheme 6.1. This scheme detailing constituents of various polymeric substances (eg, natural or synthetic) and their construction processes as outlined in the previous section is important in defining medical textiles aptly. Similarly, testing the properties and performance of medical textiles with suitable methods under accredited standards is essential. Thus, it is worthwhile to adequately describe all test methods, performance testing features, results analysis, and presentation guidelines of test results prior to marketing and commercialization of a device or product. This is done so that care and quality assurance of medical textiles will be documented appropriately, which benefits users. 

In response to ever-increasing innovation and development of medical textiles, medical textile performance testing is required during the manufacturing process. The test requirements developed by the European Medical Devices Directive are presented in this section. There are different classes of test methods and standards. However, the conformity with each test standard depends on the types and classes of the medical... 

There are many ways textiles can be contaminated, due to their uses and/or through their environment. Potential threats include germs and fungi. However, there are a number of antimicrobial and antifungal medical textiles available nowadays. Antimicrobial performance testing using appropriate standard methods, test results, validation, and documentation is important. These tests are described in the foUowing section. 

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