IEC 60601-1 Voting Rejects New Version

27% of the votes on the new version of 60601-1 were opposed to advancing it to FDIS. If more than 25% oppose, then it fails so it was rejected. The voting countries made numerous comments and a meeting is being held in Paris in October 2002 to discuss the issues. There appears to be concern about requiring use of 14971 because there is a belief that that then requires a third party assessment to claim compliance with 60601-1. In other words, some want 60601-1 to be a test standard, not a process standard. There are other issues as well. The complete voting result is at the link provided.

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