Conformity

Movesense MD Sensor

Electromagnetic compatibility, electrical safety, product safety and performance standards fulfilled by the Movesense MD medical grade ECG and motion sensor:

Medical Device Standards

  • IEC60601-1:2005 + A1:2012 Medical electrical equipment – part 1: General requirements for basic safety and essential performance
  • IEC60601-1-2:2014 Medical electrical equipment – part 1-2: General requirements for basic safety and essential performance. Collateral standard: electromagnetic disturbances. requirements and tests
    • CISPR 11:2009 +A1:2010 Radiated emissions Class B, group 1
    • IEC 61000-4-2:2008 ESD immunity, ±8kV contact, ±2, ±4, ±8, ±15kV air
    • IEC 61000-4-3:2006 +A1:2007 +A2:2010 Radiated field immunity 80 MHz-2.7 GHz, 10 V/m
    • IEC 60601-1-2:2014 Table 9 IMMUNITY to proximity fields from RF wireless communications equipment.
    • IEC 61000-4-8:2009, Power frequency magnetic field immunity: 30 A/m, 50 and 60 Hz
  • IEC 60601-1-11:2015 Medical Electrical Equipment – part 1-11: General requirements for basic safety and essential performance. Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
  • IEC60601-2-47:2012 Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems; taking into account the intended use and limited analysis functionality of the Movesense MD device
  • IEC 62479:2010 Assessment of the compliance of low-power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz)

Other standards

  • FCC 47 CFR Part 2.1093
  • ISED RSS -102 Issue 5:2015 FCC Rules and Regulations CFR 47, Part 15, Subpart C (10-1-15 Edition) & ICES-003 ISSUE 6 (2016)
  • USA FCC Part 15.247, 15.209
  • CANADA RSS-247, RSS-Gen Radio Frequency Devices. Operation within the bands 902 – 928 MHz, 2400 -2483.5 MHz, and 5725 – 5850 MHz. Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-Exempt Local Area Network (LE-LAN) Devices. General Requirements and Information for the Certification of Radio Apparatus.
  • IEC 60601-1-6:2010 + A1:2013
  • EN ISO 15223-1:2006
  • EN ISO 10993-1:2009 + AC:2010
  • IEC 62366-1:2015
  • EN 1041:2008
  • EN 62304:2006 + A1:2015

 

Movesense HR, HR2 and HR+ Sensors

  • RED 2014/53/EU
  • RoHS 2 directive 2011/65/EU
  • EN 62479:2010
  • ETSI EN 301 489-1 V2.2.3 (2019-11)
  • ETSI EN 301 489-17 V3.2.4 (2020-09)
  • EN 62368-1:2014 + AC:2015 + AC:2017 + A11:2017
  • IEC 62368-1:2014 + COR1:2015 + COR2:2015
  • ETSI EN 300 328 v2.2.2 (2019-07)
  • EN IEN IEC 63000:2018
  • FCC 47 CFR Part 2.1093
  • ISED RSS -102 Issue 5:2015 FCC Rules and Regulations CFR 47, Part 15, Subpart C (10-1-15 Edition) & ICES-003 ISSUE 6 (2016)
  • USA FCC Part 15.247, 15.209
  • CANADA RSS-247, RSS-Gen Radio Frequency Devices. Operation within the bands 902 – 928 MHz, 2400 -2483.5 MHz, and 5725 – 5850 MHz. Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-Exempt Local Area Network (LE-LAN) Devices. General Requirements and Information for the Certification of Radio Apparatus.

 

Please contact info@movesense.com, if you need additional information.

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