Technical Data - ResMed ResScan Manual

Technical Data

Standards
ResScan is compliant with the following standards:

ISO 13485:2003
Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes

ISO 14971:2007
Medical Devices—Application of risk management to medical devices

IEC 62366:2007
Medical Devices—Application of usability engineering to medical devices

IEC 62304:2006
Medical Device Software—Software life-cycle processes

EN 980:2008
Symbols for use in the labeling of medical devices

EN 1041:2008
Information supplied by the manufacturer of medical devices
Symbols
Software and Packaging
Batch code
Catalogue number
Manufacturer
Follow instructions for use
European Authorised Representative
Technical Data
English 53