Conformity

ISO 13485:2016 Medical Device Quality Management System

Movesense Ltd is an ISO 13485:2016 certified company. ISO 13485:2016 standard specifies requirements for a quality management system mandatory for an organization involved in one or more stages of the life-cycle of medical devices. The Movesense medical QMS certification covers design, development, production, final inspection, sales and distribution of wearable medical sensors and accessories. The quality management system of Movesense was audited and certified by Eurofins Electric & Electronics Finland Ltd.

Movesense MD Sensor

Product number MS060222000: MDR 2017/745

Product number SS050341000: MDD 93/42/EEC, Classification rule: Class IIa per Annex IX, rule 9. Conformity Assessment Route: Annex II.

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.

The lists above are non-exhaustive, and will be updated as required. Please contact info@movesense.com, if you need additional information.