Enraf Nonius Tecarpuls, Instructions For Use Manual

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27 of 32 EN109-1730752-41
13.5 Environmental conditions
Environmental conditions for transportation and storage
Environment temperature : - 10
0
C till + 40
0
C.
Relative humidity : 10 till 90 % (no condensation)
Atmospheric pressure : 500 till 1060 hPa
Environmental conditions for normal use
Environment temperature : - 10
0
C till + 40
0
C.
Relative humidity : 10 till 90 % (no condensation)
Atmospheric pressure : 800 till 1060 hPa
13.6 Classification
: 2460
Classification of Tecarpuls
•
Class IIa according to the Medical Devices Directive (MDD 93/42)
Software
•
Class A according to EN ISO 62304, Software Safety Classification
Implemented Safety Standards
•
IEC 60601-1: Medical Electrical Equipment – Part 1: General requirements for safety
•
IEC 60601-1-2: Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance – Section 2: Collateral standard: Electromagnetic disturbances -- Requirements and tests
•
IEC 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral
standard: Programmable electrical medical systems
•
IEC 60601-1-6: Medical Electrical Equipment – Part 1: General requirements for safety – Section 6:
Collateral standard: Usability
•
IEC 60601-1-11: Medical electrical equipment -- Part 1: General requirements for basic safety and
essential performance
– Section 11: Collateral standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare environment
•
EN ISO 62304: Medical device software – Software life-cycle processes
•
EN ISO 14971: Medical devices – Application of risk management to medical devices
•
EN ISO 10993: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process
13.7 Manufacturing Standards
•
EN ISO 13485 Medical devices – Quality management systems Requirements for regulatory purposes