medical device standards

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...