[Relevancy and binding character of standards for the safety of medical devices].
Medical devices are essential for diagnosis and therapy of diseases. To ensure that this large and heterogeneous product group is safe and fulfills the expected performance, there are national and international laws and directives which define essential requirements for medical devices. Since it is not possible on the level of a law to demand concrete specifications for completely different products which in addition are subject to technical improvement, there are references to the relevant standards in the legal regulations. When writing a technical standard, the experts of the particular standard committee incorporate the current state of technology. It is important to the standard committees that as many as possible of all groups who are interested in a specific subject actively participate in the development of the standard. Hence, standards guarantee safety for patients and user, while also supporting the manufacturer in fulfilling the various international requirements and regulations.
Rölleke
T
T
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Alle 3, 53175 , Bonn, Deutschland. roelleke@bfarm.de
D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D017751:Safety Management / Q000331:legislation & jurisprudence* / Q000592:standards*