Also provides comprehensive risk management files
XP Power has announced that its 25W to 2500W medical power supply products have been approved to the new IEC60601-1 3rd edition standard. In contrast to other manufacturers who may only provide 2 x MOOP (means of operator protection), XP Power’s medical safety compliance extends to providing 2 x MOPP (means of patient protection). Also available are the complete risk management files required by the 3rd edition. The provision of these files remove the burden and expense typically placed on the end-product designer in achieving product compliance.
IEC 60601-1 is the harmonized standard for medical electrical equipment that has been adopted globally. In Europe the new 3rd edition standard is mandatory from June 1, 2012, and will apply to both new products introduced after that time as well as products already in existence. All of XP’s medical power supplies are now approved to EN60601-1:2006 to meet this requirement.
In the United States the applicable standard is ANSI/AAMI ES60601-1:2006, and the requirement does not take effect until 1 July, 2013. Only new products brought to market after this date will be required to meet 3rd edition. In Canada the standard CAN/CSA C22.2 No. 601.1 will be used to signify their products meet the new requirements and their effective date is the same as the EU on June 1, 2012. Canada has also adopted the policy in that only new products will need to meet the standard. XP Power’s medical power supplies are also approved to both US and Canadian standards.
Manufacturers of medical equipment need to be aware of the major changes required in moving from the existing 2nd edition medical safety approval to the 3rd edition standard as the standards are very different.
To aid this process XP Power have prepared a white paper that can be downloaded from here: http://www.xppower.com/pdfs/IEC60601_Understanding.pdf