Normes de sécurité – ITC Hemochron Signature+ Whole Blood Microcoagulation System Manuel d'utilisation

Page 57

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NORMES DE SÉCURITÉ
L'instrument HEMOCHRON Jr. Signature+ répond aux exigences 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/CE.

Tous les documents relatifs à ce sujet sont conservés dans les locaux d'ITC à Edison, (New Jersey, États-
Unis).

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