General Requirements for Safety to:
Lock Lab EN60601-1:2006 + A12:2014
Accessory Network Hub UL60950BS EN 62368-1, 2nd Edition:2014 + A11:2017
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 of 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 theatre, anaesthetic gas 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, sterile, or life- or safety-critical environments.