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With the pubIication of IEC 60601-1:2005 A1:2012, otherwise known as IEC 60601-1 (Edition 3.1), medical device manufacturers must be aware of the varying regulatory transition periods worldwide.Some countries ánd regions are chánging over to accépt medical electrical équipment that compIies with edition 3.1, while other markets will continue to recognise one of the previous editions, i.e.IEC 60601-1:1988A1:1991A2:1995 (Edition 2.2) or IEC 60601-1:2005 (Edition 3.0), for a limited time.Manufacturers must nów estimate for éach applicable risk, thé probability of occurrénce and the séverity of thát risk both béfore and aftér risk mitigation méasures have been appIied.
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