IEC 60601 testing and certification services for global markets

IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. In addition to basic safety requirements, the third edition with amendment 1 includes requirements for essential performance, software, usability, lasers and EMC that can be delivered locally via our own test labs where customers can witness their tests.

IEC 60601-1 3rd edition with Amendment 1

The 3rd edition of IEC 60601, issued in 2005 with Amendment 1 is in various states of adoption by regulatory bodies around the world. IEC 60601 continues to use process standards such as Risk Management, Usability and Software in addition to requirements detailed in the 60601-1 series of standards. UL technical experts continue to serve on the international technical committees that develop and revise the IEC 60601-1 series of standards, so medical customers who work with UL on their testing, documentation and certification needs gain the advantage of working with the global leaders in third-edition IEC 60601-1 knowledge. For both new products and products upgrading to the new standard, in order to minimize test failures, we recommend companies use UL to assess the conformity according to the standard even at early stage development. Please contact UL to help determine the best certification option for your product, your markets, and your business.

Global Adoption Status and Transition Dates – IEC 60601 Edition 3.0 and 3.1

 European Union (EU) General Standard with  Amendment 1, EN 60601-1:2006/A1:2013  (IEC60601-1, Edition 3.1)  January 1, 2018
 European Union (EU) Particular Standards, EN60601-2-xx  Varies*
 Canada (Health Canada) General Standard,  CSA  C22.2 No. 60601-1:14 (IEC60601-1,  Edition 3.1)**  August 31, 2015
 Canada (Health Canada) Particular Standards,  CSA C22.2 No. 60601-2-xx)  Varies
 United States (OSHA), General Standard,  UL60601-1 (IEC60601-1, Second Edition)  Current Standard
 United States (OSHA), General Standard,  AAMI ES60601-1:2005 (R2012) (IEC60601-1, Edition 3.1)  Listed as an OSHA Appropriate Test Standard
 United States (FDA), General Standard,  ES60601-1:2005 (IEC60601-1, Edition 3.0)  July 1, 2013
 United States (FDA), General Standard,  ES60601-1:2005 (R2012) (IEC60601-1, Edition  3.1)  August 1, 2016
 Brazil (IEC60601-1, Edition 3.1) Required
 Japan General Standard, JIS T 0601-1  (IEC60601-1, Edition 2.0) Valid until May 31, 2017
 Japan General Standard, JIS T 0601-1  (IEC60601-1, Edition 3.0)  Published June 1, 2012
(Valid until February 28, 2019)
 Japan General Standard, JIS T 0601-1  (IEC60601-1, Edition 3.1)  Published March 1, 2014
(Required  transition March 1, 2019)
Singapore – (IEC 60601-1, Edition 3.0)  Accepted
 Taiwan – (IEC 60601-1, Edition 3.1)  Currently Accepted, required by 30 June 2019
 South Korea 2014 (IEC60601-1, Edition 3.0)  June 1, 2014: Classes 3 and 4 + 14  Particular  Products
 South Korea 2015 (IEC60601-1, Edition 3.0)  June 1, 2015: Class 2 + 21 Particular  Products
 South Korea 2016 (IEC60601-1, Edition 3.0)  June 1, 2016: Class 1 + 19 Particular  Products
 South Korea (IEC60601-1, Edition 3.1)  January 1, 2018
** The equivalent Canadian National Standard CAN/CSA-C22.2 NO. 60601-1:14 is also on the recognized standards list under “Electromedical.”

 

*Medical devices that fall within the scope of a particular standard are subject to various dates as noted by the Official Journal of the EU for EU. UL will continue to provide testing to the 2nd edition of IEC 60601-1 and its associated particular standards as long as regulatory bodies continue to recognize it. For those companies launching global products, it may be necessary to maintain a certified 2nd edition test report with local country deviations and also a 3rd edition test report. UL provides integrated test plans to support global safety requirements.

UL services for IEC 60601 based standards

  • Option of using the question based approach or an on-site audit-based approach to demonstrate conformity to IEC 60601-1:2005
  • Public and private training to IEC 60601 2nd and 3rd editions, differences, ISO 14971, Amendment 1 and more
  • Gap assessment to IEC 60601 and ISO 14971
  • IEC 60601 Proactive Review – Early engagement for both 2nd and 3rd edition to support demanding project completion schedules.
  • Options for evaluations to IEC 60601 2nd and 3rd editions
  • Potential for reduced FUS inspections and integrated quality system (ISO 13485 and/or ISO 14971) assessments
  • CB Scheme test reports and test certificates
  • Software assessments to support IEC 60601 Clause 14 and, if requested, IEC 62304
  • Usability assessments to support Collateral standard IEC 60601-1-6 and, if requested, IEC 62366
  • EMC testing and assessments to support IEC 60601-1-2
  • Home Healthcare assessments to support IEC 60601-1-11

CB Scheme for IEC 60601-1

As the leading medical National Certification Body (NCB), UL can also use your test results to prepare a CB Test Report. In addition, UL can authenticate this report by issuing a CB Certificate, which can be used to apply to other CB Scheme participating countries for local marketing approvals. As the # 1 Issuer of CB Certificates, UL CB reports are widely recognized and accepted at certification agencies around the world. Testing on site has many advantages for manufacturers who want to control test schedules, have staff onsite for mitigation purposes and meet production deadlines. UL can come to your site to conduct witness testing and certify qualified manufacturing sites to do testing under the CB Scheme. If you have the equipment and qualified personnel to do testing on site, ask about UL’s data acceptance program. Click here for news and updates on IEC 60601

IEC 60601 Related Articles and White Papers

This article was originally published in the September/October 2011 issue of Biomedical Instrumentation & Technology (BI&T), a bimonthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org. Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.

Resources, case studies and tools to support IEC 60601

IEC 60601 3rd edition Related Technical Training