After the third CDV/DIS the project was rejected in April. It passed ISO and failed IEC and CENELEC. Although the project was within the proposed deadline at the IEC/SC 62A plenary meeting it was decided that:
1) SC 62A will propose to cancel IEC 62304 2nd edition of its work program after failing the 3rd CDV.
2) IEC 62304:2006/A1:2015 will remain and the project stability date will be changed to 2025.
3) The SC62A secretariat will circulate the results of the national votes and will request feedback from the National Committees regarding the next stage of this project
SC 62A Request
Submit any idea or proposal to determine the future of IEC 62304
▫ Reformulate IEC 62304
▫Change echo
▫Split document
▫ Clarify scope, etc...
Annex A was carried out in conjunction with IEC/SC62A – ISO/215/JWG7 and contains the analysis of the causes of disapproval of this standard and some recommendations that can help in the development of comments and proposals.
▫Deadline for submission 10/01
Participate!
If you want to participate in the elaboration of the Brazilian vote on the fate of IEC 62304, see the schedule and instructions in the post Preparation of the vote on the fate of the 2nd Edition of IEC 62304.