Why does Europe require compliance with the 3rd edition for new and legacy products, while other markets require it only for new products?

 It is worthwhile pointing out that other markets (e.g. Canada) allow continuation of 2Ed-approved devices only in the case that no product changes whatsoever have been introduced after 1 June 2012. Once the first product change is introduced after 1 June 2012, the whole MEE must comply with 3rd ed IEC 60601-1:2005. A medium-sized MEE usually undergoes around 100 – 300 product changes per year (component level). Consequently extension of the transition period of other markets for 2Ed-approved MEE is likewise limited in these markets. In addition, the European requirement makes sense from a safety perspective. If legacy products were allowed to be marketed before the transition period is over, then the 2Ed would have to continue for many years because manufacturers might claim that no product changes had been conducted after 1 June 2012 (which would be unrealistic).

Do you have a question ask it here?

Leaders in EMC Testing , Environmental Testing, Safety Testing, Radio and Telecoms Testing, CE Marking, Vibration Testing, Climatic Testing, Certification, Training and Consulting