Qardio QardioCore, Руководство пользователя

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3. FCC part B 15B:2013 Electromagnetic Compatibility
4. FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC
Rule Part: 15.247 Cat: DTS (BT4.0)
5. EN ISO 10993-1:2009/AC:2010 Biological evaluation
of medical devices-Part 1: Evaluation and testing
within a risk management process (ISO 10993-
1:2009)
6. EN ISO 10993-5:2009 Biological evaluation of
medical devices - Part 5: Tests for in vitro cytotoxicity
(ISO 10993-5:2009)
7. EN ISO 10993-10:2009 Biological evaluation of
medical devices -- Part 10: Tests for irritation and
skin sensitization
8. EN 55011 Group 1 Class B:2009+A1:2010 :
Industrial, scientific and medical equipment - Radio-
frequency disturbance characteristics - Limits and
methods of measurement
9. IEC60601-1-2: Part 1-2: General requirements for
basic safety and essential performance – Collateral
Standard: Electromagnetic disturbances
10. IEC 60601-2-47 Ambulatory electrocardiographic
monitors
11. ANSI/AAMI EC57: 2012 Testing and reporting
performance results of cardiac rhythm and ST
segment measurement algorithms
12. EN 300 328 V1.9.1: 2015 Electromagnetic
compatibility and Radio spectrum Matters (ERM);
Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band
and using wide band modulation techniques;
Harmonized EN covering the essential requirements
of article 3.2 of the R&TTE Directive
13. EN 301 489-1 V1.9.2 (2011-09) Electromagnetic
compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for
radio equipment and services; Part 1: Common
technical requirements