Hi,
My name is Bao Vo from Bolt Medical. One of your sale people, Jynae Jones, recommended me to ask questions in the community forum. Would you help to provide the CE certification of the part ANTCW2EA? We need this part in our system to ship to Europe so our Quality ask for CE certification (in pdf). Thank you very much for your help.
Best Regards,
Bao Vo
What certification are you looking for?
The antenna is not RF certified as as standalone unit. The combination of the device and its antenna has RED certification in the EU. The same is true for safety certifications like EN62368.
The antenna itself is RoHS certified, that information is in the antenna datasheet which can be downloaded here.
The antenna should not require REACH certification is it is not manufactured in the EU and does not contain enough chemicals to require it for importation.
I am looking for CE certification (in pdf) for this part since we use this into our system to ship to Europe.
What is RED certification? would you send me this certification in pdf? I can discuss with quality team if it is acceptable. Thanks.
There is no general "CE Certification." There are requirements for various things, and radio equipment generally requires Radio Equipment Directive certification (2014/53/EU), commonly referred to as RED.
But even RED isn't a single thing. It's a collection of certifications based on the frequencies used by the device. Wi-Fi and BLE devices require EN 301 908, for example. Cellular devices require EN 301 511.
RED doesn't apply to the individual components in the system. Only the final assembly, which includes the transmitter and antenna. Thus you will never find EN 301 511 or other RED certifications for an antenna, because measuring the RF output of an isolated antenna with no transmitter makes no sense. It's always 0.
The exception to this is RoHS, which does apply to individual components.
The RED certification documents for Particle devices with their certified antenna are on the certification page. They're dependent on the device you are using.
Hi @duybao
As @rickkas7 said above, Particle have certificates for the RF part (RED) of the CE mark, but you will also need at least a LVD or Low Voltage Directive for safety of the power supply you choose. This could be easy or hard depending your choices for a power supply.
For a medical device there is a MDD or Medical Device Directive which requires extensive testing of the final product for safety and and a quality review from an outside body.
Once you have your product put together you should plan on hiring a CE testing lab to help you with these certifications.
Thank you rickkas7 and bko for your explanation. Is it possible if you can send me REACH statement (in pdf) as you said above: "The antenna should not require REACH certification is it is not manufactured in the EU and does not contain enough chemicals to require it for importation." or something like that. The same thing is for RoHS statement since the link you provided just for datasheet, not really details. This is only for documentation to put in our database. So every time we order the part, our internal QC will inspect and verify before we receive into our stock for build.
My email is duybao@boltmed.com.
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