BIO-, PHARMA- AND MEDICAL TECHNOLOGY
Guidelines and test procedures
As already mentioned, all high-performance plastics that are classified as food-compatible can be used as materials. However, it is not uncommon that proof of physiological harmlessness or biocompatibility is required for use - especially in medical technology.
In Europe, Directive 93/42/EEC prescribes binding regulations for so-called medical devices for the member states. This directive defines general requirements for medical devices and their components as well as for their design and construction. The monitoring of these requirements depends on the hazard potential of the individual medical device.
Similar to the European regulations, the American Food and Drug Administration (FDA) also divides medical devices into classes according to their monitoring effort. Products in the high surveillance classes are subject to special examinations and quality requirements according to CFR, Title 21 Part 820.
In addition to these key government regulations, there are also industrial norms and standards. Both the American United States Pharmacopeia (USP) and the International Organization for Standardization (ISO), as an association of national standardization institutes, have set standards for medical devices and their assessment with regard to the
potential risk to humans.
The USP has developed, among other things, test procedures for the biological assessment of plastics. According to these test procedures, plastics are divided into classes (Class I to VI) with increasing requirements that limit their applicability.
You can find out more about physiological harmlessness and biocompatibility here!