BS EN 45502-1:2015 - TC - Tracked Changes. 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 - TC

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

Status : Current   Published : February 2020

Format
PDF






Standard NumberBS EN 45502-1:2015 - TC
TitleTracked Changes. Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer
StatusCurrent
Publication Date25 February 2020
Normative References(Required to achieve compliance to this standard)EN ISO 14155:2011-10, IEC 60601-1:2005/A1:2012, EN 60068-2-47:2005, ISO 14971:2007, IEC 60068-2-27:2008, ISO 14155:2011, EN 60068-2-27:2009, EN 60068-2-64:2008, ISO 8601:2004, IEC 60068-2-14:2009, ISO 10993-1:2003, EN 60068-2-14:2009, IEC 60601-1:2005, EN ISO 10993-1:2009, IEC 62304:2006, ISO 11607-1:2006, EN 62366:2008, IEC 62366:2007, EN 60601-1:2006, EN ISO 11607-1:2006, EN 62304:2006, IEC 60068-2-47:2005, EN ISO 14971:2012, IEC 60068-2-64:2008, EN 60601-1:2006/A1:2013
Informative References(Provided for Information)IEC 60068-2-64:1993, EN ISO 15223-1:2012, ISO 15223-1:2012, AAMI TIR42:2010, EN 62127-1:2007, ISO/TR 14283:2004, ISO 10993-9:2009, 90/385/EEC, 2001/83/EC, IEC 62127-1:2007, EN ISO 17665-1, ISO 17665-1, ISO 7000, EN ISO 11137-2, ISO 13485, ISO/TS 10974, EN 50061:1988, ISO 14937, EN ISO 13485, EN ISO 11135-1, ISO 11135-1, EN ISO 11137-1, FIPS PUB 199, EN 60068-2-64:1994, EN ISO 14937, ISO 11137-1, 1999/519/EC, 96/29/EU, ISO 11137-2, EN ISO 10993-9:2009, 90/385/EEC
DescriptorsImplants (surgical), Environmental testing, Safety measures, Instructions for use, Delivery, Mechanical testing, Ultrasonic hazards, Durability, Electrically-operated devices, Electromagnetic compatibility, Protected electrical equipment, Electric charge, Thermal testing, Marking, Dielectric-strength tests, Accident prevention, Leakage currents, Electrical testing, Packages, Testing conditions, Impulse-voltage tests, Sterile equipment, Reliability, Test equipment, Endurance testing, Design, Biological analysis and testing, Performance, Life (durability), Prosthetic devices, Voltage, Compatibility, Defibrillators, Radio-wave hazards, Temperature, Hazards, Electrical safety, Electrostatics, Packaging, Ultrasonic testing, Electrical medical equipment, Medical equipment
ICS11.040.40
CommitteeCH/150/2
ISBN978 0 539 08728 4
PublisherBSI
FormatA4
DeliveryYes
Pages145
File Size4.919 MB
Price£330.20


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