Performance testing methods, medical

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

BS EN 13795 2011+A1, 2013. Surgical Drapes, Gowns and Clean Air Suits, Used as Medical Devices for Patients, Clinical Staff and Equipment. General Requirements for Manufacturers, Processors and Products, Test Methods, Performance Requirements and Performance Levels. 

This section details some of the testing methods used and accepted within the medical device industry for characterizing the performance of the package. These methods will be used to validate the packaging processes and to establish performance specifications for ctmtinuous monitoring of quality. 

Filters used in medical respirators is defined in a specified EN standard, BS EN 13328-1 2001 Breathing system filters for anaesthetic and respiratory use. Salt test method is used to assess filtration performance. 

Cen 2011. EN 13795 2011+A1 2013. Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment—General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels. 

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. 

The current Japanese guidance document, titled Test Methods for Biological Safety Evaluation of Medical Devices, Assessment of Medical Device, Notice 36,2003, partially embraces ISO 10993, but it has technical specifications to perform tests that differ from the procedures specified in ISO 10993. As a consequence, many Japanese regulators do not readily accept testing conducted according to ISO 10993. Such reluctance will likely to continue until the techifical sections of these two standards are harmonized. At present the techifical conduct of many studies differs enough for the end point requirements of a Japanese test to be different from the requirements of ISO, and vice versa. Additional testing may thus be required to submit a medical product for Japanese approval. 

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