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
