Ivyhealth IVBT01 Manual De Usuario página 7

Applicable Standards
EN 980:2008
EN 1041:2008
EN ISO
14971:2012
EN 60601-
1:2006
EN 60601-
1-2:2007/
AC:2010
EN 60601-1-
6:2010
EN IEC 60601-
1-11:2010
EN
62366:2008
EN
62304:2006/
AC:2008
EN ISO 10993-
1:2009/
AC:2010
EN ISO 10993-
5:2009
EN ISO 10993-
10:2009
ISO 80601-2-
56:2009
Graphical symbols for use
in the labelling of medical
devices
Information supplied by the
manufacturer with medical
devices
Medical devices – Application
of risk management of
medical devices
Medical electrical
equipment – Part 1: General
requirements for basic safety
and essential performance
Medical electrical equipment
– Part 1-2: General
requirements for basic safety
and essential performance
– Collateral standard:
Electromagnetic compatibility
– Requirements and tests
Medical electrical equipment
– Part 1-6: General
requirements for basic safety
and essential performance –
Collateral standard: Usability
Medical electrical equipment
– Part 1-11: General
requirements for basic safety
and essential performance
– Collateral standard:
Requirements for medical
electrical equipment and
medical electrical systems
used in the home healthcare
environment
Medical devices – Application
of usability engineering to
medical devices
Medical device software –
Software life-cycle processes
Biological evaluation of
medical devices – Part 1:
Evaluation and testing within
a risk management process
(ISO 10993-1:2009)
Biological evaluation of
medical devices – Part 5:
Tests for in vitro cytotoxicity
(ISO 10993-5:2009)
Biological evaluation of
medical devices – Part
10: Tests for irritation and
delayed-type hypersensitivity
Medical electrical equipment
– Part 2-56: Particular
requirements for basic safety
and essential performance
of clinical thermometers
for body temperature
measurement