Todd robinson wrote: > 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 emission! > s 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 any! > one 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 > It would only be emissions for AS/NZS 2064 1&2
I am not sure why you feel the product is not suitable to self declare as an ISM category product. The TGA web site address is: http://www.health.gov.au/tga/ You will find a list of contact numbers for different areas of interest within the TGA via the web page. I believe the main area of concern from the TGA point of view will be if the device is used in patient diagnostic/treatment situations (ie connected to the body etc). Hope this helps. Best regards, Kevin Richardson Ph: 02-43-29-4070 Stanimore Pty Limited Fax: 02-43-28-5639 "The Technology Requirements Specialists" Int'l: +61-2-43-2x-xxxx Email: Internet: [email protected] Compuserve: 100356,374
