Environmental Conditions; Classification : 2460; Manufacturing Standards - SportTec 27535 Manual De Instrucciones

13.5 Environmental conditions

Environmental conditions for transportation and storage
Environment temperature
Relative humidity
Atmospheric pressure
Environmental conditions for normal use
Environment temperature
Relative humidity
Atmospheric pressure
13.6 Classification
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
0 0
: - 10 C till + 40 C.
: 10 till 90 % (no condensation)
: 500 till 1060 hPa
0 0
: - 10 C till + 40 C.
: 10 till 90 % (no condensation)
: 800 till 1060 hPa
: 2460
27 of 32 EN109-1730752-41