ITC Hemochron Response Whole Blood Coagulation System - Manuel (Page 45)

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NORMES DE SÉCURITÉ
L'instrument HEMOCHRON Response est conforme aux normes et directives de sécurité suivantes:
CSA C22.2. 601.1. Medical Electrical Equipment – General Requirements for Safety
EN 60601-1 /
IEC 60601-1/
UL 60601-1
Medical Electrical Equipment – General Requirements for Safety
EN 60601-1-2 /
IEC 60601-1-2
Medical Electrical Equipment – Part 1-2 – General Requirements for
Safety – Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests
EN 61000-3-2 Electromagnetic Compatibility – Limits – Limits for Harmonic Current
Emissions
EN 61000-3-3 Electromagnetic Compatibility – Limits – Limitation of Voltage Changes,
Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems
EN 55011 Industrial, Scientific and Medical (ISM) Radio Frequency Equipment –
Radio Disturbance Characteristics – Limits and Methods of Measurement
EN 61326 Electrical Equipment for Measurement, Control and Laboratory Use –
EMC Requirements
Directives: 89/336/CEE et telle qu'amendée par 91/263/CEE, 92/31/CEE, 93/68/CEE, 98/13/CE et
98/79/EC.