rob73
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BSI have now released BS EN ISO 14971:2012, more informative references between the standard and MDD 93/42EEC have been added, specifically:
*Treatment of negligable risks
*Discresionary power of manuf. as to the acceptability of risks
*Risk reduction "as far as possilbe" VS "as low as reasonably possible"
*Discretion as to whether as risk benifit analysis needs to tkae place
*Discretion as to the risk control option/measures
*Deviation as to the first risk control method
*Information of the users influencing the residual risk
Rob
*Treatment of negligable risks
*Discresionary power of manuf. as to the acceptability of risks
*Risk reduction "as far as possilbe" VS "as low as reasonably possible"
*Discretion as to whether as risk benifit analysis needs to tkae place
*Discretion as to the risk control option/measures
*Deviation as to the first risk control method
*Information of the users influencing the residual risk
Rob