medical device standards

Medical electrical equipment standards are complex—and noncompliance is costly. This article breaks down the top 10 barriers manufacturers face when navigating IEC 60601 and related standards, from EMC testing and isolation diagrams to risk management and software documentation, with practical guidance to streamline certification and avoid delays.

The IEC 60601 family of standards is undergoing its most significant update in decades. This article explains how the 4^th Edition of IEC 60601‑1 restructures safety, performance, terminology, and collateral requirements—and what these changes mean for medical electrical equipment development, conformity assessment, and future regulatory pathways.

This article discusses where we are currently with the IEC 60601 series of standards and where we are headed for the next round of amendments (2020 - 2022). Further down the line is the development of the next full edition of the IEC 60601 Series (targeting around 2024 publication).

The International Electrotechnical Commission (IEC) has released a new amendment to Part 1 of IEC 62489-1. The...

ANSI has released a new edition of ISO 13485:2016, the standard for "Medical devices - Quality management systems - Requirements for regulatory purposes." The revised standard can now be purchased from ANSI's standards store.

The International Electrotechnical Commission (IEC) has published an amendment to IEC 62563-1:2009. The new publication...