[Biocompatibility and quality control of pacemaker (author's transl)].
The Authors examine the functional, toxicological and pharmacological controls routinely performed on materials and on the finished products. They propose a biocompatibility protocol for screening materials, and they compare Italian regulations on quality control and good manufacturing practice of medical devices with foreign regulations.
D001672:Biocompatible Materials; D004566:Electrodes / Q000592:standards; D006801:Humans; D007558:Italy; D010138:Pacemaker, Artificial / Q000592:standards*; D011786:Quality Control; D014481:United States
D001672:Biocompatible Materials
Biocompatibilità' e problemi di controllo nei pacemakers.