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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.