IEC 60601-1 Third Edition –introduction and implementation dates

The IEC, which stands for International Electrotechnical Commission, dates its founding to more than a century back, to 1906. It is the world’s leading voluntary organization for regulation of the technologies that collectively go into electronic components and are bunched together as electrotechnology.

In setting standards for electronic and electrical gadgets, the IEC regulates, in effect, millions of electronic devices that go into the market. It has set out the IEC International Standards and Conformity Assessment Systems, ensuring compliance with which these devices work safely and effectively.

Medical Safety IEC 60601-1, 3rd Edition

The IEC 60601-1, 3rd Editionconcerns regulations for electronics that go into medical devices. These are the highlights of IEC 60601-1 standard, 3rd Edition:

More than 60 device standards are derived from this standard, thus making it the parent standard for these device standards. The third edition was issued in 2005, and has set the following mandatory adaption dates for compliance for these respective markets:

  • Europe: June 1, 2012
  • Canada: June 1, 2012
  • USA: July 1, 2013


Medical device manufacturers in all these markets must conform to new revised guidelines within the deadlines prescribed for their respective markets. Apart from using risk management throughout, the other highlight of the newly revised IEC 60601-1, 3rd Editionstandard is that it is less prescriptive in many areas. It leaves many such areas for broader interpretation. Also, the new IEC 60601-1, 3rd Edition requires that all applicable collateral and particular standards must be used for compliance.



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