Methods, standards and validation

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 

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

Polyethylene film Contaminated donor material Fixation metel ring 

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. 

3 Test method for evaluation of cleanliness—microbial contamination (EN 1174, replaced by EN ISO 11737) 

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