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ZMPCZM016000.13.04 EC Declaration of Conformity NexWave

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ZMPCZM016000.13.04 EC Declaration of Conformity NexWave

  1. 1. EC Declaration of Conformity Manufacturer: Zynex Medical, Inc. 9990 Park Meadows Drive Lone Tree, CO 80124 United States of America EC Representative: Zynex Europe Fælledvej 1, Box 19 BDO DK-5100 Odense C DENMARK We declare, using the conformity assessment route, through Council Directive 93/42/EEC of 14 June 1993, Concerning Medical Devices, Annexes II and VII, as amended by Directive 2007/47/EC, that the NexWave Combo Muscle Stimulator and products of this type manufactured for sale by other distributors, classified using Annex IX, Rule 9 and 10 of Council Directive 93/42/EEC as Class IIa, meet the essential health and safety requirements and are in conformity with the relevant EC Directives listed below using the relevant sections of the following EC standards and other normative documents: Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, as amended by Directive 2007/47/EC. EN 980: 1997 - Graphic Symbols for Use in the Labeling of Medical Devices EN 1041: 1998 - Information Supplied by the Manufacturer with Medical Devices ISO 14971: 2007 - Medical Devices – Application of Risk Management ISO 13485: 2003 - Quality Management Systems EN 60601-1 – Medical Electrical Equipment – Part 1: General Requirements for Safety EN 60601-1-2 – Medical Electrical Equipment – Part 1-2: General Requirements for Safety, Electromagnetic Compatibility. EN 60601-1-4 - Medical Electrical Equipment – Part 4, Programmable electrical medical systems EN 60601-2-10: 2001 – Safety of Nerve and Muscle Stimulators ICES-003: Interference-Causing Equipment Standard Signature: Thomas Sandgaard Name: Thomas Sandgaard Title: President/CEO Date: 11/18/11

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