ISO 14708-5:2010
Withdrawn
Withdrawn
View Superseded by
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-26-2010
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 14708-5:2010 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.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
| DevelopmentNote |
Supersedes ISO/DIS 14708-5. (01/2010)
|
| DocumentType |
Standard
|
| Pages |
47
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ANSI/AAMI/ISO 14708-5: 2010(R2015) | Identical |
| AAMI ISO 14708-5 : 2010 | Identical |
| NEN ISO 14708-5 : 2010 | Identical |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| 15/30290736 DC : 0 | BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| ASTM F 3020 : 2016 | Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security |
| ASTM F 2401 : 2016 : REDLINE | Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| BS EN ISO 10993-4:2017 | Biological evaluation of medical devices Selection of tests for interactions with blood |
| ASTM F 3278 : 2017 | Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security |
| I.S. EN ISO 10993-4:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017) |
| UNE-EN ISO 10993-4:2018 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| IEC 60068-1:2013 | Environmental testing - Part 1: General and guidance |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ISO 5840:2005 | Cardiovascular implants — Cardiac valve prostheses |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| AAMI TIR26 : 2000 | VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/TR 14283:2004 | Implants for surgery — Fundamental principles |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 5198:1987 | Centrifugal, mixed flow and axial pumps — Code for hydraulic performance tests — Precision grade |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO Guide 31:2015 | Reference materials — Contents of certificates, labels and accompanying documentation |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
Summarise
US$96.00
Excluding Tax where applicable
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