Standard Number | BS EN 45502-2-3:2010 |
Title | Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems |
Status | Current |
Publication Date | 31 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 Relationships | EN 45502-2-3:2010 |
Descriptors | Implants (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 |
ICS | 11.040.40
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Title in French | Dispositifs médicaux implantables actifs. Exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral |
Title in German | Aktive implantierbare Medizingeräte. Besondere Festlegungen für Cochlea-Implantatsysteme und auditorische Hirnstammimplantatsysteme |
Committee | CH/150/2 |
ISBN | 978 0 580 70990 6 |
Publisher | BSI |
Format | A4 |
Delivery | Yes |
Pages | 48 |
File Size | 583.4 KB |
Price | £246.00 |