57
MAGNAMED TECNOLOGIA MÉDICA S/A
•
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
•
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
•
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.
Physical and Environmental Specifications
Table 10
– Physical and Environmental Specifications
Parameter
Specification
Tolerance
Unit
Dimensions and Weight (basic unit)
a.
Height
1335
5
mm
b.
Width
453
5
mm
c.
Depth (with handle)
542
5
mm
d.
Weight
18
0,1
kg
Operation
a.
Temperature
-10 to 50
---
°C
b.
Barometric Pressure
600 to 1100
---
cmH
2
O
c.
Relative air humidity (non-condensing)
15 to 95
---
%
Storage
a.
Temperature
-20 to 75
---
°C
