Mario
There's no equivalent in Europe and CISPR 11 is not the right place to look The Radio Equipment Directive applies to "Radio equipment" which is defined as " ..an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;" Now, if the device ONLY ever operated when it was inside the human body, you might be able to argue that it wasn’t “radio equipment” as it didn’t emit Radio Waves, which are defined as “radio waves’ means electromagnetic waves of frequencies lower than 3 000 GHz, propagated in space without artificial guide;” as they weren’t been propagated in free space – but a counter argument would say that they aren’t fully absorbed by the body or subject to 100% internal reflection, so would propagate from the body. Ideally, your product would operate in a suitable radio band as listed in CEPT REC 70-03<https://www.ecodocdb.dk/download/25c41779-cd6e/Rec7003e.pdf> or List of Class I Frequencies<https://ec.europa.eu/docsroom/documents/40361>, but they don’t include 300 MHz as that is allocated to different use in Europe If it is very low power and really does need to operate at 300MHz, it would be possible to bring it to market, but would involve at least one Spectrum Regulator and a Notified Body Best regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 Web: https://sulisconsultants.com/ Registered in England and Wales, number 05466247 -----Original Message----- From: Mario de Aranzeta <[email protected]> Sent: 04 June 2020 19:58 To: [email protected] Subject: [PSES] intentional radiator in Europe In the US we can have an intentional radiator of a very low output power in any band except the restricted bands of 15.205 and 15.209. This allowed under 15.209(a),(c). That is if you can keep the fundamental and harmonics under the radiated limits of 15.209. Is this sort of thing possible in Europe. The device in mind is a medical device that is ingested with the fundamental at 300 MHz and a field strength under 47 dBuV/m @3m I've looked through EN55011: 2016 Table 1 and footnotes and can't see that it is or isn't. Thanks, Mario de Aranzeta, N4TSV -- This email has been checked for viruses by Avast antivirus software. https://www.avast.com/antivirus - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
