Implants for surgery. Active implantable medical devices. General requirements for safety,marking and for information to be provided by the manufacturer

BS EN 45502-1-2015

Implants for surgery. Active implantable medical devices. General requirements for safety,marking and for information to be provided by the manufacturer

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发布日期： 2015-06-30

实施日期： 2015-06-30

ICS分类号： 11.040.40 - 医药卫生技术 - 外科植入物、假体和矫形

全文来源： WF

英文关键词： 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 Endurance tests Bodies Output capacity Permanency Power Presentations Storage quality Shaping Stress Efficiency Protection against electric shocks

语种： eng

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