IEC TC 62 has several subcommittees. One of them — IEC TC 62A — has released a revision to one of its consensus products: IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management.
Revision 62A/1359/ features:
a) structural changed to better align with ISO 31000
b) establishment of requirements and guidance for an organization in the application of risk management.
The changes appear to be largely administrative.
Comments are due January 24th. You may comment directly to the IEC at the link below:
All IEC consensus products are on our standing agenda.