ITC Hemochron Signature+ Whole Blood Microcoagulation System - Handbuch (Seite 57)

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SICHERHEITSSTANDARDS
Das HEMOCHRON Jr. Signature+ Gerät entspricht den folgenden Anforderungen und Vorschriften für
Sicherheitsstandards:
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
Richtlinien: 89/336/EEC und wie durch 91/263/EEC, 92/31/EEC, 93/68/EEC, 98/13/EC und
98/79/EC abgeändert.
Alle relevanten Dokumentationen werden bei ITC in Edison, NJ, USA gespeichert.