IEC PAS 63621 2026 published
By Mitch on Friday, 24 April 2026, 15:58 - Standards - Permalink
IEC PAS 63621 2026 - Artificial intelligence enabled medical devices - Data management, has been published in March 2026.
A PAS is a Publicly Available Specification, a kind of early version of a standard. It was developed by IEC at a pace quicker than usual. Too quick to follow the long process of standard development.
This document is definitely a missing link in the chain of activities performed to design Medical Devices incorporating Artificial Intelligence (MDAI). This better explains why a PAS was published with a fast track process. MD industry couldn't be left without such standard.
This document describes a data management process for MDAI. Something we already explained in this post about data management.
The post was based on IEC 5259-x series. Fortunately, we retrieve the same steps in IEC 63621:
- Data Requirements,
- Data Planning,
- Data Acquisition,
- Data Development,
- Data Provisioning,
- Data Decommissioning.
The only difference: Data Preparation in IEC 5259-x is replaced by Data Development in IEC 63621. Data development is a process where data are prepared and verified against data quality criteria. This is already present in IEC 5259-x. The new provision present in IEC 63621 is an iterative process to ensure continuous improvement of data quality criteria.
The other main differences between are:
- IEC 5259-x series is a full set of standards, covering various aspects of data management for AI.
- IEC 63621 is focused on the core process, present in IEC 5259-2,
- IEC 5259-x target any industry, requiring intensive interpretation to match medical device safety and performance goals, and personal health data regulatory requirements,
- IEC 63621 target medical devices. Thus, little interpretation is needed to implement your own processed. But not more than any other MD standard,
- IEC 63621 requires to make a link with risk management and identify if data can contribute to a hazardous situation. In such case, the process described in the PAS shall be followed.
Looking for ideas on how to implement this PAS? You can use the Data Management Plan template.
