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IEC 60601-1-8 Ed. 2.0 (2006)/A1:2012 (EN 60601-1-8:2007/A11:2017) - 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 60601-1-4: 1996/A1:1999 (EN 60601-1-4: 1996/A1: 1999) - Medical electrical equipment -
Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical
systems
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IEC 60601-1-6: 2010 (EN 60601-1-6:2010) - Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
•
IEC 62366: 2007 (EN 62366:2008) - Medical devices - Application of usability engineering to
medical devices
•
EN ISO 17665-1:2006 - Sterilization of health care products - Moist heat - Part 1: Requirements for
the development, validation and routine control of a sterilization process for medical devices
•
EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
•
EN 1041:2008 - Information supplied by the manufacturer of medical devices
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ISO 15223-1: 2016 (EN ISO 15223-1:2016) - Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied - Part 1: General requirements
•
ISO 80601-2-61:2011 (EN ISO 80601-2-61:2011) – Medical electrical equipment: Particular
requirements for basic safety and essential performance of pulse ox equipment
•
ISO 80601-2-55:2011 (EN 80601-2-55: 2011) - Medical electrical equipment -- Part 2-55:
Particular requirements for the basic safety and essential performance of respiratory gas monitors
11.3 Especificaciones Físicas y Ambientales
Parámetro
a.
Altura
b.
Ancho
c.
Profundidad (con asas)
d.
Peso
a.
Temperatura
b.
Presión barométrica
Tabla 7 - Especificaciones Físicas y Ambientales
Dimensiones y peso (unidad básica)
Operación
MAGNAMED TECNOLOGIA MÉDICA S/A
Especificación
Tolerancia
1335
453
542
18
-10 a 50
600 a 1100
Unidad
5
mm
5
mm
5
mm
0,1
kg
---
°C
---
cmH
O
2
67
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