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
What is the Scope of IEC 60601-1:2005 (3rd edition)?