ISO 14708-2:2005
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
- Standard No.
- ISO 14708-2:2005
- Release Date
- 2005
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 14708-2:2012
- Latest
- ISO 14708-2:2019
- Scope
- This Part 2 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in ISO 14708 are type tests, and are to be carried out on samples of a device to show compliance. This Part 2 is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this Part 2 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2 shall apply. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by another ISO document under development.
ISO 14708-2:2005 history
- 2019 ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
- 2012 ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
- 2005 ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
