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efeRencias y aveRías
Descripción técnica
Estándares utilizados en el desarrollo de la bomba
Se han utilizado los siguientes estándares en la totalidad o en parte del desarrollo de la bomba.
Equipos electromédicos:
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
Compatibilidad electromagnética:
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).
Otros estándares
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)
Funcionamiento esencial
®
La bomba CADD
-Solis presenta las características de rendimiento esencial siguientes:
El rendimiento de la bomba cumplirá la tasa establecida dentro de los límites declarados de precisión,
de acuerdo con las condiciones nominales, o emitirá una alarma.
Las alarmas de alta prioridad de la bomba seguirán siendo operativas.
Los sistemas protectores de la bomba siguientes estarán operativos o emitirán una alarma:
• Autocomprobación del reloj de la bomba
• Prueba del circuito de seguridad del motor
• Detección de desechables
• Detección de aire
• Detección de oclusiones
• Sensores de seguro/bloqueo
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