[Standardization, control and approval of surgical implants in Europe].
The "new approach" policy limits the European Community legislative harmonization to adopting essential safety requirements which medical devices brought on the market will have to meet, and thereafter obtaining free trade in the European market. A set of harmonized standards will explain in detail what the essential requirements mean in practice. Therefore, the work being done on standards for surgical implants by the European Committee for Standardization (CEN) is indispensable. The impact of the "New Approach" on the Norwegian legislation is discussed, and it is concluded that the Committee for Single-Use Medical Devices, which registers all surgical implants prior to marketing in Norway, will have to close down in 1995.
Reigstad
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Statens senter for ortopedi, Avdeling Kronprinsesse Märthas Institutt, Oslo.
D001672:Biocompatible Materials / Q000009:adverse effects / Q000592:standards*; D004869:Equipment Safety; D005060:Europe; D006801:Humans; D007391:International Cooperation; D009664:Norway; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards*; D011785:Quality Assurance, Health Care; D011786:Quality Control; D012307:Risk Factors
D001672:Biocompatible Materials
Standardisering, kontroll og godkjenning av kirurgiske implantater i Europa.