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Description technique
Normes utilisées pour le développement de la pompe
Les normes suivantes ont été utilisées en tout ou en partie pour le développement de la pompe.
Matériel électrique médical:
EN 60601-1 (2006 + A1:2013 + A11:2011 + A12:2014) Ed3.1, Medical Electrical Equipment, Part I: General
Requirements for Safety. Amendment A1 (1993) Amendment A13 (1996) Amendment A2 (1995).
EN 60601-2-24 (2015), Medical Electrical Equipment, Part 2-24: particular Requirements for Safety of Infusion
Pumps and Controllers.
IEC 60601-1 (2005 + A1:2012) Ed3.1, Medical Electrical Equipment, Part 1: General Requirements for Safety.
Amendment 1 (1991) Amendment 2 (1995).
IEC 60601-2-24 (2012), 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).
ANSI/AAMI ES60601-1 (2005/(R2012) + A1:2012) Ed 3.1, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-8 (2012), Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
EN 60601-1-8 (2007 + AC:2010), Medical electrical equipment - Part 1-8: General requirements for basic safety and
essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 62304 (2015), Medical device software - Software life-cycle processes
EN 62304 (2006 + AC:2008), Medical device software - Software life-cycle processes
Compatibilité électromagnétique :
RTCA/DO -160G (2010), Radiated Emissions Only, Category M Limit.
EN 60601-1-2 (2015), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-2 (2014), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests.
CISPR11 (2016), Limits and methods of measurement of electromagnetic disturbance characteristics of industrial,
scientific and medical (ISM) radio frequency equipment. Amendment 1 (1999) Amendment 2 (2002).
Normes diverses
IEC 60529 (2001), Degrees of protection provided by enclosures (IP Code).
EU RoHS Directive 2011/65/EU, Restriction of Hazardous Substances in Electrical and Electronic Equipment
REACH Regulation (EC) No.1907/2006, Registration, Evaluation, and Authorization of Chemicals (REACH)
2012/19/EU, Waste Electrical and Electronic Equipment (WEEE)
Performances essentielles
®
La pompe CADD
-Solis présente les caractéristiques suivantes en matière de performances essentielles :
La perfusion sera réglée au débit indiqué dans les limites de précision déclarées dans des conditions
nominales ou déclenchera une alarme.
Les alarmes de haute priorité de la pompe resteront opérationnelles.
Les systèmes de protection de la pompe suivants seront opérationnels ou déclencheront une alarme :
• Autotest de l'horloge de la pompe
• Test du circuit de sécurité du moteur
• Détection d'élément jetable
• Détection d'air
• Détection d'occlusion
• Capteurs de verrouillage
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ÉFÉRENCES ET DÉPANNAGE
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