KIEL INSTITUTE

This applies to devices that may cause electromagnetic interference or be affected by such interference. To ensure that these devices operate properly without causing harmful interference in an electromagnetic environment and without being affected by other sources of electromagnetic interference, EMC requirements are applied to the relevant equipment.

This certification applies to all electrical and electronic devices that emit and receive radio waves at frequencies up to 3000 GHz.

This certification pertains to medical devices, and in Europe, they are categorized into three types: general medical devices, in vitro diagnostic medical devices, and active implantable medical devices. Different regulations apply to each category. This guideline specifically addresses general medical devices.

Devices that cause electromagnetic interference or may be affected by such interference
※ Excluded Items

• Wireless devices used by amateur radio operators that are not commercially available
• Means specially used to address EMC issues (Directive Article 6)
• Devices re-exported overseas
• Devices exhibited at trade shows

Airborne products, parts and appliances not excluded by Annex I.3 of RED,
Base Station for Mobile Network, Broadcast radio and TV receivers, Citizens Band radio
Broadcast transmitters, Distress / Position Indicating Beacon, Cordless Telephone
Fixed Wireless Access, Fixed Link, Maritime(for Non-SOLAS vessels), Industrial,
Scientific, and Medical within scope of directive, Paging(Radio Messaging), Mobile
(Cellular) Telephone Handset
Radar, Private / Professional Mobile Radio, Radio Local Area Network,
Radio Frequency Identification(RFID), Short Range Device(SRD),
Satellite Earth Station(Fixed / Mobile), Ultra Wideband, Wireless Microphone, GPS Receivers

All medical devices (excluding in vitro diagnostic and active implantable medical devices): Medical devices intended for therapy and diagnosis purposes