Medical Devices are designed and rigorously tested to IEC60601 group of standards in a certified laboratory. This extensive Type testing, sometimes to the point of destruction is carried out prior to the medical device being released for sale.
In Australia, the results of the tests are submitted to Therapeutic Goods Administration and when approved, the medical devices can be sold here.
Standards Australia have failed to provide a clear on-going Electrical Safety Testing regime for medical devices with the release of AS/NZS3551:2012 as Appendix B of the standard contained omissions1, incorrect interpretations of international standards2 and added tests that would not in any way show additional electrical hazards3 that were already covered in AS/NZS3551:2004.
You will need a copy of AS/NZS3551:2012 & Amendment 2 to highlight the problem areas from the following discussion.Posted by