Textile materials commonly used standards

Although the range of textile materials is very large, focusing on implantable devices narrows the scope. Chemical biocompatibility is an essential requirement. A close look reveals that only about 50 materials are commonly used compared to more than 1.5 Mio materials that exist. This shows how necessary it is to take into account chemical constraints of implantable medical devices to meet the requirements of standards and regulatory processes (Table 13.3). 

The textile process of embroidery allows a manufacturer to stich a yarn material to a textile in a highly defined geometry [Gries et al, 2007], To begin the process, the pattern is designed to specifications. Then the pattern is brought into specialized embroidery software for punching. A file definition is made and then is then converted into embroidery machine code. There are three commonly used types of embroidery standard embroidery, chain stitch embroidery, and tailored fiber placement. Each of these processes will be further defined. 

Caution must be applied in the use of ISO 10993 and its various parts. Device developers and regulators alike default to using Part 1 of this standard as a checklist . Not all assays described in the various parts are applicable to all device materials. Sometimes the form of the material can lead to false positives in certain studies. Not all parts of the standard provide sufficient detail to allow the uninformed to appreciate that various labs may claim to conduct testing to the standard but use widely varying protocols. Cytotoxicity assays quite commonly result in positive findings, as has occurred in testing silver-coated textiles and materials with hydroxylapatite... 

The standard spectra are run using pure compounds and include the common organic reagents. The commercial series includes dyes, stains, plasticizers, monomers, polymers, polyols, resins, rubbers, soaps, fatty acids and drying oils, solvents, surface-active agents, textile chemicals, waxes, petroleum chemicals, intermediates, and pharmaceuticals. These spectra reflect the materials as they are available commercially, and list their trade as well as chemical names. 

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