Can anyone please advise as to which other directives and regulations are required for a medical implant which incorporates an RFID sensor, in addition to ISO13485. I do not need to know about FDA requirements as we are a european company and not selling into the US or Canada, just Europe at present. Also I have been told that there is a "frequency" regulation, does anyone know the reference number for this. It refers to the RFID signal/output. OK, many thanks in advance.

If you are not looking for FDA information, what exactly would you be looking for?

Also, what kind of chips are you looking to implant-Passive or active?

Hi there and thanks for the quick response. It is a passive rfid which is activated using a reader. We work to ISO13485 already, but this is a new field for me (RFID/sensors) and I need to get involved with the design / development aspects and as such whether there are any regulatory requirements that exist for specifically RFID sensors that are implanted into the body rather than used for other items.

There are some out there. I did some research on this a while back. There are some web sites dedicated to this. Do you already have them, or would you like them posted here?

Hi there again. Many thanks again for your promptness. I would be grateful for the links.

Look at IEC 60601 series of standards.

Hi

I'm not certain if they apply in this case, but I would check out the LVD(2006/95/EC), EMC(89/336/EC) and the R&TTE(1995/5/EC) Directives. Also EN 50364:2001 (Limitation of human exposure to electromagnetic fields from devices operating in the frequency range 0 Hz to 10 GHz, used in Electronic Article Surveillance (EAS), Radio Frequency Identification (RFID) and similar applications) may be applicable.

Thank you so much for the help and advice. I will go and have a look at the references/standards that you have both given. :D:thanks:

I forgot to mention that the ultimate decision on what standards would apply are with your Notified Body. Any advice you receive should be verified with them first.

Yes Thanks Al. I appreciate that, we work very closely with our Notified Body and have done for many years. However, I just wanted to be aware of what the applicable standards and regulations would be so that I can be prepared when we meet with them in a fortnight's time. I didnt want to arrive "empty handed", if you know what I mean. Many thanks once again for all the help. This is a great site, it is very useful to obtain other people's thoughts and ideas. So BIG THANK YOU ELSMAR COVE..........:thanx: