I am working on an electronic medical device certification for one of our customers. The product has already passed CE (EMC)requirements, EN60601-1-2, including CISPR 11 Emissions testing. From an EMC standpoint, do we need to do anything besides emissions for AS/NZS 2064, 1&2?
It doesn't seem that this product can go through the ISM self-declaration route. The ACA has strongly suggested that I contact the TGA (Therapeutic Goods Administration) for further information. I have a phone and fax number (no contact person). Does anyone have any additional information? A contact? An E-mail? A Website? Todd Robinson Marketing Manager CKC Laboratories, Inc. 800-500-4362 http://www.ckc.com
