By Norbert Leitgeb
The publication discusses the felony and technical specifications for brands, designers and testers of electromedical units. It describes which stumbling blocks has to be triumph over to introduce a clinical equipment at the eu industry, but additionally informs readers as to pitfalls and possibilities, and during which manner safeguard should be accomplished and product legal responsibility constrained. It explains how the newly required hazard administration strategy, which contains probability research, chance overview, possibility administration and possibility keep an eye on, will be applied. As a last crucial attention, the ebook describes which security necessities are to be met and the way they are often chuffed and tested.
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Additional info for Safety of Electromedical Devices: Law — Risks — Opportunities
41 depend in the morning (4th risk factor), and had to borrow your neighbour’s car (5th risk factor) to still reach her office in time. Since coffee is important, you decide to have at least instant coffee and take your time to heat some water (6th risk factor). When it is ready you realize that the instant coffee had been used up by your visitors (unexpected coupling of a usually independent event). Because of the time loss and the missing coffee you become nervous (7th risk factor). To make an impression at the interview you decide to change your suit (8th risk factor).
G. absorbable sutures (III) I IM IS IIa IIb III 22 Safety of Electromedical Devices. Law – Risks – Opportunities No. Classification rules na I IM IS IIa IIb III IM IS IIa IIb III – is it for undergoing long-term chemical change (except devices placed in teeth or administering medicines)? (III) e. g. bone cement would change too rapidly (already during placement) – is it for administering medicine? (III) e. g. rechargeable non-active drug delivery systems Table 1-3: Classification rules for active medical devices (MDD, Annex IX) No.
Non-invasive, natural-invasive, surgical-invasive; – site of application, e. g. suction devices could be intended for use inside the mouth (class I), inside surgical wounds (class IIa) or inside the lung (class IIb); – kind of contact, e. g. contactless, contact with clothing, intact or wounded skin, surgical wounds, blood circulatory system, heart or central nervous system; – duration of use, e. g. transient, short-term, long-term, permanent. product characteristics – condition, e. g. non-sterile or sterile; – usability, e.