ISO 14708-5:2010
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
- Standard No.
- ISO 14708-5:2010
- Release Date
- 2010
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 14708-5:2020
- Latest
- ISO 14708-5:2020
- Scope
- This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps. This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
ISO 14708-5:2010 Referenced Document
- IEC 60601-1 Medical electrical equipment - ALL PARTS*， 2015-01-20 Update
- IEC 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-19 Update
- IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CO...*， 2020-07-01 Update
- IEC 62304 Medical device software - Software life cycle processes*， 2015-06-01 Update
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 Update
- ISO 14708-1 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer*， 2014-08-01 Update
- ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
- ISO 5198 Centrifugal, mixed flow and axial pumps; Code for hydraulic performance tests; Precision grade
- ISO 5840 Cardiovascular implants - Cardiac valve prostheses
- ISO 7198 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches*， 2016-08-01 Update
ISO 14708-5:2010 history
- 2020 ISO 14708-5:2020 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
- 2010 ISO 14708-5:2010 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
