有源植入物

本类别共 6 条标准。

标准编号	标题	适用范围	GSPR
EN 45502-1:2015	Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer	General requirements for active implantable medical devices	19, 19.3
EN 45502-2-1:2003+A1:2020	Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)	Active implantable medical devices -- Particular requirements for active implant...	14, 18, 19
EN 45502-2-2:2008+A1:2020	Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)	Active implantable medical devices -- Particular requirements for active implant...	14, 18, 19
ISO 14708-2:2019	Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers	Active implantable cardiac pacemakers.	10, 14, 14.2
ISO 14708-3:2017	Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators	Active implantable neurostimulators.	10, 14, 14.1
ISO 14708-7:2019	Implants for surgery - Active implantable medical devices - Part 7: Cochlear implant systems	Active implantable cochlear implant systems.	10, 14, 14.1