3rd edition – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 02 Oct 2013 10:51:56 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png 3rd edition – Eisner Safety Consultants https://eisnersafety.com 32 32 What is the Scope of IEC 60601-1:2005 (3rd edition)? https://eisnersafety.com/2013/10/02/iec-60601-1-3rd-edition/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-3rd-edition Wed, 02 Oct 2013 10:51:56 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3492 This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product.  Definitions, third-party testing, etc. discussed.

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

This blog discusses the following points:

  • Definitions
  • Examples within Scope of IEC 60601-1:2005
  • Examples not within Scope of IEC 60601-1:2005
  • IEC 60601 & ISO 13485
  • Third-Party Testing
]]> 2013 RAPS Regulatory Conf. Presentation – IEC60601-1 3rd ed., Managing Human Factors & Usability Risks https://eisnersafety.com/2013/09/10/2013-raps-regulatory-conf-presentation-iec60601-1-3rd-ed-managing-human-factors-usability-risks/?utm_source=rss&utm_medium=rss&utm_campaign=2013-raps-regulatory-conf-presentation-iec60601-1-3rd-ed-managing-human-factors-usability-risks Tue, 10 Sep 2013 05:01:26 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3456 Join us at the 2013 RAPS Regulatory Convergence Conference (Boston) in the Medical Device Track on IEC 60601-1 Third edition: Managing Human Factors and Usability Risks.  Your experts that will help you through these issues are Leo Eisner of Eisner Safety Consultants, and Mark Leimbeck and Michael Wicklund of UL LLC and will be presenting on Wednesday 8 October, 2013 8:30 – 10AM in Boston at the John B. Hynes Veterans Memorial Convention Center.

As you know Risk management is a necessary, yet onerous, task when developing electro-medical devices. Since IEC 60601-1 3rd ed. was published, manufacturers have faced many new risk management challenges with respect to their electro-medical devices, especially home health devices.

Avoid the common pitfalls of risk management in IEC 60601-1 3rd ed. Experts will share case studies in their risk management practices for their own devices.

Come join us at the RAPS Convergence Conference to learn more on this subject.

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