IEC 60601 3rd Edition: Overview and Adoption Update

The IEC 60601 3rd Edition represents a major change in the way medical devices are evaluated and approved. This audio conference will provide an overview of the major differences between the 2nd and 3rd Editions of the standard, including process changes for assessing acceptable risk, in addition to the electrical and mechanical changes.

Because the changes have a major impact on the way certification is viewed, there is still a lot of discussion among the major medical markets on how to interpret the standard, what national differences to include, and what requirements will be required to assess conformity. We also provide an update on the adoption status in the major medical device markets.

IEC 60601 3rd Edition: Overview and Adoption Update aired on 2007-09-13 and is available for download at www.fxconferences.com

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

This event is presented by Harvey Rudolph of Underwriters Laboratories. To learn more, please visit www.fxconferences.com.