Earlier this year the US followed the EU and Canada in moving to the 3rd edition of the IEC 60601-1 medical device standard. Diese Änderung bringt einige neue Herausforderungen und erhöht die Komplexität für Entwickler medizinischer Geräte. The article “Understanding the Impact of 60601 3rd Edition on Power Design” examines the changes and their effect on implementing power supplies in medical devices.
Published on EDN.com, the article begins, “Designers of medical systems are faced with changes and challenges as safety-standards legislation is updated around the world. Over the past couple of years, governments in Europe and North America have decided to move to the 3rd edition of the IEC 60601-1 standard, which has important ramifications for the power supplies they incorporate.”
“Covering many aspects of medical-systems safety, the IEC 60601-1 standard was first published in 1977, to be replaced by the 2nd edition, which was developed in the late 1980s. In 2005, the IEC published its 3rd edition. The 2nd edition has, in a number of jurisdictions, been in force for many years, but several key regions globally have recently made the move to adopt the 3rd edition standards.”
“The European Union withdrew the 2nd edition standard at the start of June 2012, replacing it with the 3rd. Products already on sale as well as products new to the market now must conform to the regional version of the IEC standard, EN 60601-1:2006. If 3rd edition assessments are missing for products currently on sale government agencies in the European Union can order sales of the affected equipment to be stopped.”