Technical Description - SIMS Deltec CADD-Legacy PLUS Operator's Manual

Section 5: Reference

Technical Description

Standards used in Development of the Pump
The following standards were used in whole or part in the develop-
ment of the pump.
Medical Electrical Equipment
IEC 60601-1, Medical Electrical Equipment, Part 1: General Re-
quirements for Safety.
IEC 60601-1-1, Medical Electrical Equipment, Part 1: General
Requirements for Safety. Collateral Standard: Safety requirements
for medical electrical systems.
IEC 60601-1-2 (1993), General Requirements for Safety, Part 2:
Electromagnetic Compatibility — Requirements and Tests.
IEC 60601-1-2, (2nd Edition, 01-June-1996) Medical Electrical
Equipment, Part 1: General Requirements for Safety. 2. Collateral
Standard: Electromagnetic Compatibility — Requirements and
Tests.
IEC 60601-1-4, Medical Electrical Equipment, Part 1: General
Requirements for Safety — 4. Collateral standard: Programmable
electrical medical systems.
IEC 60601-2-24, Medical Electrical Equipment, Part 2: Particular
Requirements for the Safety of Infusion Pumps and Controllers.
Electromagnetic Compatibility
RTCA/DO -160C, Radiated Emissions Only, Category A & Z Limit.
CISPR11, Radiated and Conducted Emissions, Group 1, Class B.
CISPR14, Radiated and Conducted Emissions, device powered by
AC adapter only.
For CISPR11 and CISPR14 tests, the pump was fitted with an
administration set with its inlet connected to a 250 ml bag and its
outlet routed back to the bag forming a closed loop system. A total
of six feet of tubing was used to form the closed loop.
IEC 61000-3-2, Harmonic Distortion, Class A equipment, only for
devices powered @ 220 VAC or greater.
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