By Norbert Leitgeb
The publication discusses the criminal and technical specifications for brands, designers and testers of electromedical units. It describes which hindrances has to be conquer to introduce a clinical machine at the ecu marketplace, but in addition informs readers as to pitfalls and possibilities, and during which method security may be completed and product legal responsibility constrained. It explains how the newly required threat administration approach, which contains hazard research, possibility overview, threat administration and chance regulate, may be carried out. As a last crucial attention, the e-book describes which defense requisites are to be met and the way they are often chuffed and proven.
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Additional info for Safety of Electromedical Devices: Law - Risks - Opportunities
Example text
For clinical testing” "#$# Figure 1-8: Paths to CE- marking and inclusion of European Notified Bodies for conformity assessment and certification (indicated by the “certificate” boxes) 1 Medical devices 27 ment file, draws up a legally binding declaration of conformity and affixes the CEmark on the product and its packaging (without adding any notified body identification number).
G. to get lung cancer from smoking or skin cancer from UV tanning). There are several parameters responsible for our distorted view of risks. For example, when driving a car the risk is perceived as much smaller than it really is. The reasons are, familiarity with driving, the existence of safety means (e. g. safety belts, airbags), the feeling of control through our own efforts (e. g. by adequate behaviour, speed control, quick reaction). In fact, the skill in driving a car seems to be one of the most fairly distributed abilities: One rarely finds anyone claiming to be a bad driver!
Dosimeter 11 Is it an active product for administering and/or removing substances (e. g. medicines, body liquids) to or from the body? (IIa) e. g. suction devices, feeding pumps, jet injectors, nebulizers na I 23 1 Medical devices No. Classification rules na I IM IS IIa IIb III – except … is this done in a potentially hazardous manner (in regard to substances, site of body, mode of application)? (IIb) e. g. infusion pumps, ventilators, anaesthesia machines, dialysis equipment, blood pumps for heart-lung machines, hyperbaric chambers, medical gas mixers, drug nebulizers, critical care moisture exchangers Table 1-4: Special classification rules for medical devices (MDD, Annex IX) Grey fields signify the resulting conformity class if the answer to a question is “yes,” if a question does not apply, the field “NA” (not applicable) must be marked No.