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BS EN 45502-1:1998
Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer
32 стр.
Заменен
Печатная копияПечатное издание
229.82 £ (включая НДС 20%)
Разработчик:
Зарубежные/BSI
ICS:
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
Ключевые слова:
Implants (surgical), Prosthetic devices, 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