Despite senior committee members being given a list of problems 5 months after it was released, no action has been taken to withdraw or amend AS/NZS3551:2012.
I believe however that HE-003 may meet soon so let us hope that a sensible standard is produced that truly reflects a field test standard for use in Australia rather than a committee playing lets pull this bit out of IEC 60601-1.
Let us also hope the committee understands that we do not have an electrical hazard problem with electro-medical devices and that the final document is even simpler than AS/NZS3551:2004 and cut down on the wasted time and cost of electrical safety testing.
Hopefully they will re-emphasize the importance of performance testing of medical devices.
MEMIE A’ASIA PTY LTD: January 2015