Astrodyne Power MedAlert!

Click here to download the full article.

The acceptance of UL 60601-1 3rd edition is stalled. The IEC is debating how risk management should be assessed. In fact, test labs training is scheduled as early as this April 1-3 in Milan, Italy. The industry also has objections to the inclusion of IEC 60601-1-9, which addresses environmental aspects of medical electrical equipment.

Taken together, this raises significant issues for medical power supply designers and specifiers. Without auditing of the risk management process, product approval under IEC 60601-1 3rd edition may be subject to questions with the further consequence of to having to re-test! So until all 3rd Edition issues are resolved, a European withdrawal date will not be set. The net effect is that the UL 60601-1 2nd edition will remain valid until at least 2012, since withdrawal dates typically have 3 year transition time. Additionally, it is not clear whether the FDA will accept the UL 3rd edition.

All this ambiguity means that until there is global agreement and recognition of the 3rd edition, there will remain questions and risks associated with having products approved to that standard. In this timely article entitled “Evolving Standards Reshape Medical Power Supplies,” Peter Resca and David Murray discuss the current and proposed medical equipment standards and their associated issues. To stay current with industry requirements, medical power supply designers and specifiers alike should find this article to be an indispensible resource.

Click here to download the full article.