IEC 60601-1 Third Edition: Looking Forward

08 August 2011

Over the last few months, this blog has specifically taken an in-depth look at key factors surrounding IEC 60601-1 Third Edition. Currently, the acceptance of the Third Edition is becoming mature, as more regulatory bodies decide to accept it.

Of particular concern to most medical device manufacturers is their preparedness to meet the Risk Management requirements under the Third Edition. A third-party testing laboratory is a key factor in helping any company address the following elements:

  • Address device design
  • Review and assess risk analysis
  • Evaluate the risk management file
  • Assess the suitability to the Third Edition series of standards

To learn more about Third Edition and or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com.