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Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th 5th September 2007.
Electromagnetic Compatibility to EMC Directive 2014/30/EU
Electrical Safety to Low Voltage Directive 2014/35/EU.

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General Requirements for Safety to:
EN60601EN 60601-1:2006 + A12:2014

Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN ISO 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance

9 September 20204th May 2021
Date Expiration 27 17th May 2024 August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8th September, 2020.

Not for use in an operating theater, anesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, dust ingress, high vibration, sterile, or life- or safety-critical environments.

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