Cardioline HD+ - Harmonised Standards Applied

HD+
9. TECHNICAL SPECIFICATIONS
34
Environmental Specifications ...........
Storage and operating conditions:
Ambient temperature: 0°C; +40°C
Relative humidity: 25%; 95%
Atmospheric pressure: 700 mbar; 1060 mbar
Classification of Medical Devices .....
IIa in compliance with the directive 93/42/EEC.
9.1. Harmonised standards applied
STANDARD
DESCRIPTION
EN ISO 15223-1
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements
EN 1041
Information supplied by the manufacturer of medical devices
EN 1789
Medical Vehicles and their Equipment - Road Ambulances
EN ISO 13485
Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971
Medical devices - Application of risk management to medical
devices
EN 60601-1
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
EN 60601-1-2
- Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
EN 62304
Medical device software - Software life-cycle processes
EN 60601-1-6
Medical electrical equipment - Part 1: General safety
requirements - Collateral standard: Usability
EN 62366
Medical devices - Application of usability engineering to
medical devices IEC 62366:2007 (*)
EN 60601-1-11
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 60601-2-25
Medical electrical equipment - Part 2-25: Particular
requirements for the safety of electrocardiographs
CEI 308-1
"Information table concerning the end of life of electric and
electronic products and compilation guide"
CEI 308-2
"Management of the end of life of electric and electronic