ITC Hemochron Signature+ Whole Blood Microcoagulation System - Manual (Page 49)

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SAFETY STANDARDS
The HEMOCHRON Jr. Signature+ instrument complies with the following safety standard requirements
and directives:
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/EEC and as amended by 91/263/EEC, 92/31/EEC, 93/68/EEC, 98/13/EC, and
98/79/EC.
All the relevant documentation is kept on file at ITC in Edison, NJ.