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