[Are the equipment safety standards sufficient to guarantee safety from risks?].
The output of the work done by National and International Committee and Commission today gives an almost complete frame of Safety Standards for Medical Devices; EEC Harmonised Standards which have been translated in the National ones gave the Free Trade Act an effective push forward. This paper analyses the problem given by the "Safety Assumption" of certified products, which is based on a positive Project examination and/or a positive prototype test made by a Notified Body, as requested by the existing warranty that every unit produced after the applied control or test has the same behaviour as the verified one: on the other hand it is out of the reality to submit every unit produced after the tested one to the same control. For the necessary and requested assumption of safety of every unit produced after the verified one, it is mandatory to act on the complete productive process, in order to reach the certainty that every unit be absolutely identical to the approved one. It is therefore in the interest of the buyers to require in the Tender Specification not only the Safety Standard Certificate for the products to be quoted, but also the Quality Standard Certificate of the producer.
Galassini
A
A
D004867:Equipment Design / Q000592:standards; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007390:International Agencies / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards*; D012306:Risk; D012449:Safety