IEC 60601 Testing and Certification

Safety requirements of medical electrical devices

The growing complexity of medical electrical devices requires more advanced testing and certification to evaluate compliance to safety and performance requirements.

IEC 60601 is a widely accepted series of standards for the basic safety and essential performance of medical electrical equipment and systems. It is an important standard, and noncompliant equipment can pose a significant risk to patients.

Why is compliance to 60601 important?

Regulatory bodies across key markets require compliance to the 60601 standard. The U.S., Europe and Asia require medical devices to comply to the 60601 standard before manufacturers can launch these products in their markets. Navigating the requirements across different markets is complicated due to the varying regulatory transition periods worldwide.

To help launch their products, medical device manufacturers should actively engage with an accredited ISO/IEC 17065 product certification body such as UL LLC to help evaluate compliance with the most recent updates to the standards.

Things to know about IEC 60601-1, Amendment 2

The IEC published Amendment 2 to 60601-1 in August 2020. With updates to the base standard published, the amendments to the collateral standards quickly followed.

While many of the updates to the base standard consist of corrections or clarifications to existing requirements, some of the updates require effort on the part of manufacturers to upgrade from the previous version. This includes updates to:

• Risk management standard ISO 14971:2019
• Usability standard IEC 62366-1:2015 + AMD 1:2020
• Software standard IEC 62304:2006 + AMD1: 2015

Clause 8 updates allow IEC 62368-1:2018 compliant devices to provide means of operator protection.

Why choose UL Solutions?

Since the publication of the IEC versions of 60601-1 in late 2020, our main testing laboratories across the U.S., Europe and Asia have achieved Certified Body Testing Laboratory (CBTL) status.

Dedicated to healthcare industry innovation, UL Solutions leverages decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and help you bring your products to market faster.

Our testing and compliance engineers work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. FDA ASCA-accredited testing laboratories across the U.S., Europe, and Asia.

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Standards

• IEC 60601-1:2005/AMD2:2020
• IEC 60601-1-2:2014/AMD1:2020
• IEC 60601-1-8:2006/AMD2:2020
• IEC 60601-1-11:2015/AMD1:2020
• IEC 60601-1-12:2014/AMD1:2020
• IEC 60601-1-6:2010/AMD2:2020