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Normen die zijn gehanteerd bij het ontwikkelen van de pomp
De volgende normen zijn geheel of gedeeltelijk toegepast bij het ontwikkelen van de pomp.
Medische elektrische apparatuur
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).
Elektromagnetische compatibiliteit
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.
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.
EN 55011 (1998), Industrial, scientific and medical (ISM) radio frequency equipment - Radio disturbance
characteristics - Limits and methods of measurement. Amendment 1 (1999), Amendment 2 (2002).
Diverse normen
USB 1.1 Universal Serial Bus (USB) Specification, Revision 1.1, September 23, 1998 – USB.org
EN 1041 (1998), Information supplied by the manufacturer with medical devices.
IEC/TR 60878 (2003), Graphical symbols for electrical equipment in medical practice.
EN 980 (2003), Graphical symbols for use in the labeling of medical devices.
IEC 60529 (2001), Degrees of protection provided by enclosures (IP Code).
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