Electrical Safety Testing for Medical Devices

Application Highlights!

QuadTech engineers write many application notes and whitepapers about industry applications and QuadTech’s equipment. We’ve highlighted some electrical safety testing applications for medical devices we think you may find helpful.

All of our content is free. To make it easier for you, add as many applications notes to your shopping basket as you like, then check out at the end for access to all of the materials. Enjoy!

IEC60601-1 3rd Edition Leakage Current Differences - New! (035167)

Requirements for hazards, marking and documentation, as well as other topics within IEC 60601-1 will impact the way medical devices are evaluated for compliance.  A major area of electrical safety testing that medical device manufacturers need to be concerned with is Electrical Hazards, and in particular, leakage current.  While almost everything has remained the same from the 2^nd to 3^rd edition of IEC 60601-1 in terms of leakage current, there are some changes for medical device designers and manufacturers of test and measurement equipment to be aware of.  

Learn more about the leakage current changes from the 2^nd to 3^rd edition of

IEC 60601-1.

National Deviations to IEC 60601-1 (035123)

What is the differences between UL2601-1 and IEC 60601-1?  What does the national standard have in addition to the international standard?  This final installment in the series of 8 articles on IEC 60601-1 illustrates some concrete examples of national deviations to the IEC 60601-1 international governing standard.  Medical device approval for electrical safety testing is also discussed.

Read more about IEC 60601-1.

Automating the Tests in IEC 60601-1

Shari Richardson, Director of Engineer – QuadTech Medical, published an Article in Conformity’s February 2008 issue talking about the IEC 60601-1 standard. The standard was developed for the early stages of product development to help medical device manufacturers comply with electrical safety testing regulations.

However, it is also applied to production line testing since it is the only way for manufacturers to be sure they are shipping a safe product. IEC 60601-1 is often also applied to production line testing, as it is the only sure way to ship a safe product. Electrical safety testing includes: leakage current, dielectric breakdown, insulation resistance, and ground bond testing. This article discusses why and how these tests are performed.

Read the complete article - Automating the Tests in IEC 60601-1.

Dielectric Strength Testing of External Cardiac Defibrillators: IEC60601-2-4 (035126)

IEC 60601-2-4, the particular standard for Cardiac Defibrillators, which requires dielectric testing for safety purposes.  Dielectric testing can be performed with an lcr meter or a hipot tester.  This application note discusses Clauses 20.2, 20.3 and 20.4 for IEC 60601-2-4 that are exceptions to the general standard, IEC 60601-1.  Detailed connection diagrams and test voltage graphs are included.

Learn more about dielectric testing of external cardiac defibrillators.

Improving Resistance Measurements

This application note describes how using a Kelvin or "4 Wire" Method for resistance testing can produce more accurate resistance measurements than a "2 Wire" method.

Learn more about the Kelvin Method and the Meridian Wire and Harness Analyzer.

Testing Ablation Catheters with QuadTech's Meridian

This application note describes how QuadTech's Meridian Wire and Harness Analyzer can be used to test ablation catheters.  An ablation catheter is used for the heart. The catheter is put into a vein and then threaded through the chambers of the heart.

The Meridian is ideal for catheter testing because of its unique operational enhancements including Kelvin probe flying lead for precision continuity testing, flex testing, and data collection and storage.

Learn more about Ablation Catheters and the Meridian.