Technical Description - Smiths Medical CADD-Solis Operator's Manual

Technical Description

Standards used in development of the pump
The 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 I: General Requirements for
Safety. Amendment A1 (1993) Amendment
A13 (1996) Amendment A2 (1995).
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: General
Requirements for Safety. Amendment 1 (1991)
Amendment 2 (1995).
IEC 60601-1-4 (2000), Medical Electrical
Equipment, Part 104: General Requirements
for Safety - Collateral Standard: Programmable
electrical medial systems.
IEC 60601-2-24 (1998), Medical Electrical
Equipment, Part 2-24: Particular Requirements
for Safety of Infusion Pumps and Controllers.
CAN/CSA-C22.2 601.1-M90, Medical
Electrical Equipment, Part 1: General
Requirements for Safety - November 1990
(Canadian Deviations to IEC 60601-1) Update
No. 2 (November 2003).
Electromagnetic Compatibility
RTCA/DO -160E (2004), Radiated Emissions
Only, Category M Limit.
EN 60601-1-2 (2001), Medical Electrical
Equipment, Part 1-2: General Requirements
for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests.
References and Troubleshooting
IEC 60601-1-2 (Edition 2.1, 2004-11),
Medical Electrical Equipment, Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic 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 (2006), Electromagnetic
Compatibility (EMC), Part 4-3: Testing and
measurement techniques. Radiated, radio
frequency, electromagnetic field immunity
test.
IEC 61000-4-4 (2004), Electromagnetic
Compatibility (EMC), Part 4-4: Testing and
measurement techniques. Electrical fast
transient/burst immunity test.
IEC 61000-4-5 (2005), Electromagnetic
Compatibility (EMC), Part 4-5: Testing and
measurement techniques. Surge immunity test.
IEC 61000-4-6 (2004), Electromagnetic
Compatibility (EMC), Part 4-6: Testing
and measurement techniques. Immunity to
conducted disturbances, induced by radio-
frequency fields.
IEC 61000-4-8 (2001), Electromagnetic
Compatibility (EMC), Part 4-8: Testing and
measurement techniques. Power frequency
magnetic field immunity test.
IEC 61000-4-11 (2004), Electromagnetic
Compatibility (EMC), Part 4-11: Testing and
measurement techniques. Voltage dips, short
interruptions and voltage variations immunity
test.
CISPR11 (2004), Limits and methods of
measurement of electromagnetic disturbance
characteristics of industrial, scientific and
medical (ISM) radio frequency equipment.
Amendment 1 (1999) Amendment 2 (2002).
EN 45502-1 (1998), Active implantable
medical devices. Part 1. General requirements
for safety, marking and information to be
provided by the manufacturer.
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