BSI BS EN 45502-1 Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer
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BSI BS EN 45502-1 Document Information:
Title
Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer
Aktive implantierbare medizinische Geraete. Allgemeine Festlegungen fuer die Sicherheit, Aufschriften und vom Hersteller zur Verfuegung zu stellende Informationen
Dispositifs medicaux implantables actifs. Regles generales de securite, marquage et informations fournies par le fabricant
British Standards Institution
Publication Date:
Feb 15, 1998
Keywords:
- Implants (surgical)
- Prosthetic devices
- Prosthesis
- Medical equipment
- Electrical medical equipment
- Electrically-operated devices
- Protected electrical equipment
- Performance
- Reliability
- Design
- Safety measures
- Accident prevention
- Marking
- Instructions for use
- Hazards
- Packaging
- Packages
- Sterile equipment
- Delivery
- Compatibility
- Biological analysis and testing
- Electrical safety
- Electrical testing
- Dielectric-strength tests
- Impulse-voltage tests
- Electrostatics
- Electric charge
- Leakage currents
- Voltage
- Defibrillators
- Temperature
- Durability
- Life (durability)
- Mechanical testing
- Environmental testing
- Thermal testing
- Endurance testing
- Radio-wave hazards
- Ultrasonic hazards
- Ultrasonic testing
- Testing conditions
- Test equipment
- Electromagnetic compatibility
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