Is your IEC 60601-1 knowledge up to date?

It is time to update your IEC 60601-1 knowledge!

How long will the outbreak last? Definitely! There is no sure answer. However, one thing for sure is every healthcare personnel is still in battle on trying to save lives. Thus, every instrument they use holds accountable. Recently, there is an update on the IEC 60601-1 (Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). Is your knowledge up to date on this? In this article, we have the information you don’t want to be missed.

What’s new?

Among many changes in this amendment, one of the notable updates is IEC 60950-1 (Information technology equipment - Safety - Part 1: General requirements) associated with will be replaced by its successor IEC 62368-1 (Audio/video, information and communication technology equipment - Part 1: Safety requirements) as it has adopted the means of operator protection (MOOP) from IEC 60950-1. The reason is information technology equipment is becoming near the main used in the medical equipment system. Thus, the protection required for the medical device operator is making the alignment between the two standards. Further, the IEC 60950-1 standard has been its place for nearly 30 years and is coming to the end.

What is the change?

The main effect will be on the design and layout that the power supply unit follows IEC 60950. However, on the bright side, with IEC 62368 replacement opens manufacturers more selection and availabilities on the main adapters.

The other major change is the relationship between the means of operator protection (MOOP) and means of patient protection (MOPP). Prior to the amendment, one could refer to a general rule of thumb: 2MOOP = 1MOPP. However, now that with Amendment 2 in place, this may or may not work depending on the scenario. This change could affect the usage criteria of certain devices, like the power supply units. When in doubt, always consult the relevant clause of the latest version of IEC 60601-1 Amendment 2, or with a qualified expert on the matter.

Is EEC Ready?

Backed in issue 4 and 5, we have covered the importance of touch current testing in IEC 60601 standard. In reminding of IEC 60601 standard, it listed out six leakage current test models. EEC has worked with many international leading test labs and medical equipment firms for years and designed its own MDs to respond to each testing criterion. We have verified the amend criteria and the MD now includes the updated IEC 62368-1.

In medical sectors, EEC medical customers utilize ESA series and 7630 touch current tester for its complete and up-to-date MDs. Our on-display MD graphic illustration allows the operator to locate the right MD quicker with no need to memorize IEC standard complex numbering. Further with simple cable connectivity, one step intuitive testing operation that optimizes overall testing efficiency.

With the unstoppable COVID-19 pandemic numbers, the battle continues. More supply will be needed. It is important for companies to understand this amend standard to minimize their impacts in advance. Extech Electronics Co. (EEC) has over 40 years of experience is aware of the importance of this change. And we have prepared and already implement such change across our machines. To make sure your battle is well served.

This article source referencing from
1. https://www.johner-institute.com/articles/product-development/2-amendment-to-iec-60601-1/
2. https://etech.iec.ch/issue/2020-05/iec-publishes-amendments-to-key-medical-device-standards

_{EEC does not hold any liability on the information. We suggest either purchase the latest copy of the IEC 60601 standard or consult with qualified 3rd party laboratories to get the most accurate information.}