Standard – 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 Standard – 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
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