Legacy® PLUS - Smiths Medical
Legacy® PLUS - Smiths Medical
Legacy® PLUS - Smiths Medical
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Reference<br />
Section 5: Reference<br />
Technical Description<br />
Standards used in Development of the Pump<br />
The following standards were used in whole or part in the development<br />
of the pump.<br />
<strong>Medical</strong> Electrical Equipment<br />
EN 60601-1 (1990), <strong>Medical</strong> Electrical Equipment, Part 1: General Requirements<br />
for Safety. Amendment A1 (1993) Amendment A13 (1996)<br />
Amendment A2 (1995).<br />
EN 60601-1-2 (2001), <strong>Medical</strong> Electrical Equipment, Part 1-2: General<br />
Requirements for Safety – Collateral Standard: Electromagnetic Compatibility<br />
– Requirements and Tests.<br />
EN 60601-2-24 (1998), <strong>Medical</strong> Electrical Equipment, Part 2-24: Particular<br />
Requirements for Safety of Infusion Pumps and Controllers.<br />
EN 60601-1-4 (1996), <strong>Medical</strong> Electrical Equipment, Part 1-4: General<br />
Requirements for Safety – Collateral Standard: Programmable electrical<br />
medical systems. Amendment A1: 1999.<br />
IEC 60601-1, (2nd Edition, 1988) <strong>Medical</strong> Electrical Equipment, Part 1: General<br />
Requirements for Safety. Amendment 1 (1991) Amendment 2 (1995).<br />
IEC 60601-1-4 (1996), <strong>Medical</strong> Electrical Equipment, Part 1-4: General<br />
Requirements for Safety – Collateral Standard: Programmable electrical<br />
medical systems.<br />
IEC 60601-2-24 (1998), <strong>Medical</strong> Electrical Equipment, Part 2-24: Particular<br />
Requirements for Safety of Infusion Pumps and Controllers.<br />
EN 980 (2003), Graphical symbols for use in the labeling of medical devices.<br />
Electromagnetic Compatibility<br />
RTCA/DO -160C, Radiated Emissions Only, Category A & Z Limit.<br />
IEC 60601-1-2, (Edition 2.1, 2004-11), <strong>Medical</strong> Electrical Equipment,<br />
Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic<br />
Compatibility – Requirements and Tests.<br />
IEC 61000-4-2 (2001), Electromagnetic Compatibility (EMC), Part 4-2:<br />
Testing and measurement techniques. Electrostatic Discharge immunity<br />
test.<br />
IEC 61000-4-3 (2002), Electromagnetic Compatibility (EMC), Part 4-3:<br />
Testing and measurement techniques. Radiated, radio frequency, electromagnetic<br />
field immunity test.