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Certification
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Medical Device TEST
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Product Details:
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Detailed Product Description
Medical Device TEST
Medical devices is a common name for the products to be used for medical purpose, it covers radio and non-radio medical device. The standards for medical devices may contain more stringent limit compared to limit for some other category products.
| 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 |
BCTC TEST LAB:www.bctc-test.org 15818554403
Contact Details
Shenzhen BCTC Testing Co.,LTD.
Contact Person: Mr. SIZ LEE
Tel: 86-158 1855 4403
Fax: 86-0755-36882626
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