ITC Hemochron Response Whole Blood Coagulation System - Handbuch (Seite 45)

45
SICHERHEITSSTANDARDS
Das HEMOCHRON Response-Gerät entspricht den Anforderungen und Vorschriften der folgenden
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/EWG und wie durch 91/263/EWG, 92/31/EWG, 93/68/EWG, 98/13/EG und 98/79/EG
abgeändert.