Does your company develop electronic medical devices? IEC 60601 is different from other regulatory compliance processes and can be challenging for medical device developers in this category. You ...

IEC 60601-1 has undergone a number of significant revisions over the years in an effort to remain current with new and advanced medical technologies.

The Amendment 1 change to Clause 4.2 of IEC 60601-1, which required ISO 14971 compliance, is the first major change discussed below. This revised requirement was comprehensively reorganized.

Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers ...

This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements. In addition, there will be practical examples of application and ...

CUI Devices’ Audio Group has announced a new line of medical buzzers compliant with the alarm signal requirements of IEC 60601-1-8.

Figure 1: IEC 60601-1 3rd edition adoption The first edition of the standard established several levels of protection to handle the different types of equipment used in medicine, as well as setting ...

The IEC 60601-1standard establishes general safety requirements for all aspects of medical devices. It includes test requirements, documentation, protection from electrical hazards, protection from ...

At AMD’s CES 2023 keynote, Magic Leap CEO Peggy Johnson confirmed Magic Leap 2 has indeed obtained IEC 60601-1 certification for its flagship AR headset.

The IEC 60601-2-25 ED. 2.0 B:2011 standard amends and supplements IEC 60601-1 ED. 3.1 EN:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential ...