대상기자재 – 의료기기

의료기기는 통상적으로 의료용으로 사용되는 모든 기기를 통칭하며, 주로 무선과 비 무선의료기기로 나눌 수 있습니다. 의료기기에 대한 규격은 다른 기타 분류된 제품보다 매우 까다롭고 엄격한 규정을 포함하고 있습니다.


Example Product Hearing Aid Devices, Implants, Implant programmer, Blood pressure monitor, Blood Sugar Monitor, Insulin Pump, Electric Wheel Chairs
Operating Frequencies 175KHz, 402 – 405MHz, 13.56MHz, 902 – 928MHz, 2400-2483.5MHz, etc.
EMC Standard EN 301 489 Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
EN 60601 Medical Electrical Equipment and Systems
Safety Standard EN 60950/UL 60950/C22.2 No.60950 Information technology equipment - Safety -- Part 1: General requirements
Radio Standard EN 302 195 Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories
EN 301 839 Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz
EN 302 537 Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz
EN 300 220 - Short Range Devices (SRD); Radio equipment to be used in the 25 MHz to 1 000 MHz frequency range with power levels ranging up to 500 mW
EN 300 328 - Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques
FCC Part 15C Intentional radiators
RSS 210 License-exempt Radio Apparatus (All Frequency Bands): Category I Equipment
RSS 310 License-exempt Radio Apparatus (All Frequency Bands): Category II Equipment
Telecom Standard N/A

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