Medel ELITE Instrucciones De Uso página 70

fety and essential performance of automated non-invasive
sphygmomanometers
IEC 60601-1-11:2015 Medical electrical equipment - Part
1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for me-
dical electrical equipment and medical electrical systems
used in the home healthcare environment
COMPLIED STANDARDS LIST
Risk management
Labeling
User manual
General Requirements for Safety EN 60601-1:2006+A1:2013+A12:2014/ IEC
Electromagnetic compatibility
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to
medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medi-
cal device labels, labelling and information to be supplied. Part 1 : General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 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
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General re-
quirements for basic safety and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EC 60601 - 1-2:2014 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compa-
tibility - Requirements and tests.
70