BS EN 45502-2-3:2010 - Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems

BS EN 45502-2-3:2010

Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems

Status : Current   Published : March 2010

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Standard NumberBS EN 45502-2-3:2010
TitleActive implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems
StatusCurrent
Publication Date31 March 2010
Normative References(Required to achieve compliance to this standard)EN ISO 14971:2007, ISO 14971:2007, EN 1593:1999, EN 13185:2001, EN 45502-1:1997, EN 55011:2007, EN 55011:2007/AMD 2:2007, CISPR 11:2003, CISPR 11:2003/AMD 1:2004, CISPR 11:2003/AMD 2:2006, EN 60068-2-27:1993, IEC 60068-2-27:1987, EN 60068-2-31:2008, IEC 60068-2-31:1969, IEC 60068-2-31:1969/AMD 1:1982, EN 60068-2-47:2005, IEC 60068-2-47:2005, EN 60068-2-64:2008, IEC 60068-2-64:2008, EN 60068-2-75:1997, IEC 60068-2-75:1997, EN 60118-6:1999, IEC 60118-6:1999, EN 60601-1:2006, IEC 60601-1:2005, EN 60601-1-2:2007, IEC 60601-1-2:2007, EN 60801-2:1993, IEC 60801-2:1991
Informative References(Provided for Information)EN 550:1994, EN 552:1994, EN 554:1994, EN 1041, EN 45502-2-1:2003, EN 50061:1988, EN 50061:1988/AMD 1:1995, EN ISO 10993-1:1997, ISO 10993-1:1997, EN ISO 13485:2003, ISO 13485:2003, HD 323.2.17 S4:1990, IEC 60068-2-17:1978, IEC 60068-2-17:1978/AMD 1:1985, IEC 60068-2-17:1978/AMD 2:1987, IEC 60068-2-17:1978/AMD 3:1989, HD 323.2.33 S1:1988, IEC 60068-2-33:1971, IEC 60068-2-33:1971/AMD 1:1978, IEC 60068-2-56:1988, ISO 5841-2:2000, ANSI/AAMI PC69:2000, ANSI/IEEE C95.1, ASTM F2052:2000, ASTM F2213:2006, ASTM F2182:2002, MIL-STD-883, 65/65/EEC, 75/318/EEC, 80/836/Euratom, 84/466/Euratom, 84/467/Euratom, 89/341/EEC, 75/319/EEC, 1999/519/EC
International RelationshipsEN 45502-2-3:2010
DescriptorsImplants (surgical), Prosthetic devices, Medical equipment, Electrical medical equipment, Hearing aids, Brain, Ears, Neural stimulators, Surgical equipment, Signal generators, Electrical impedance, Electrodes, Environmental testing, Test equipment, Testing conditions
ICS11.040.40
Title in FrenchDispositifs médicaux implantables actifs. Exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral
Title in GermanAktive implantierbare Medizingeräte. Besondere Festlegungen für Cochlea-Implantatsysteme und auditorische Hirnstammimplantatsysteme
CommitteeCH/150/2
ISBN978 0 580 70990 6
PublisherBSI
FormatA4
DeliveryYes
Pages48
File Size583.4 KB
Price£246.00


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