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

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

Status : Current   Published : June 2015

Format
PDF

Format
HARDCOPY






Standard NumberBS EN 45502-1:2015
TitleImplants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer
StatusCurrent
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN 60068-2-14:2009, IEC 60068-2-14:2009, EN 60068-2-27:2009, IEC 60068-2-27:2008, EN 60068-2-47:2005, IEC 60068-2-47:2005, EN 60068-2-64:2008, IEC 60068-2-64:2008, EN 60601-1:2006, IEC 60601-1:2005, EN 60601-1:2006/A1:2013, IEC 60601-1:2005/A1:2012, EN 62304:2006, IEC 62304:2006, EN 62366:2008, IEC 62366:2007, EN ISO 10993-1:2009, ISO 10993-1:2003, EN ISO 11607-1:2006, ISO 11607-1:2006, EN ISO 14155:2011-10, ISO 14155:2011, EN ISO 14971:2012, ISO 14971:2007, ISO 8601:2004
Informative References(Provided for Information)EN 50061:1988, EN 60068-2-64:1994, IEC 60068-2-64:1993, ISO 7000, EN ISO 10993-9:2009, ISO 10993-9:2009, EN ISO 11135-1, ISO 11135-1, EN ISO 11137-1, ISO 11137-1, EN ISO 11137-2, ISO 11137-2, EN ISO 13485, ISO 13485, ISO/TR 14283:2004, EN ISO 14937, ISO 14937, EN ISO 15223-1:2012, ISO 15223-1:2012, EN ISO 17665-1, ISO 17665-1, ISO/TS 10974, AAMI TIR42:2010, 90/385/EEC, 96/29/EU, 1999/519/EC, 2001/83/EC, FIPS PUB 199, EN 62127-1:2007, IEC 62127-1:2007
ReplacesBS EN 45502-1:1998
International RelationshipsEN 45502-1:2015
Draft Superseded By13/30233325 DC
DescriptorsImplants (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
ICS11.040.40
Title in FrenchDispositifs médicaux implantables actifs. Règles générales de sécurité, marquage et informations fournies par le fabricant
Title in GermanAktive implantierbare medizinische Geräte. Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu tellende Informationen
CommitteeCH/150/2
ISBN978 0 580 72639 2
PublisherBSI
FormatA4
DeliveryYes
Pages64
File Size2.005 MB
Price£254.00


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