ISO 5840-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
01-28-2021
English, French
09-11-2015
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ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 58403 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.
ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
ISO 5840-2:2015 excludes homografts.
| DevelopmentNote |
Supersedes ISO/DIS 5840-2. Together with ISO 5840-1 & ISO 5840-3, it supersedes ISO 5840. (09/2015)
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| DocumentType |
Standard
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| Pages |
55
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ANSI/AAMI/ISO 5840-2:2015 | Identical |
| ONORM EN ISO 5840-2 : 2015 | Identical |
| IS/ISO 5840 : Part 2 : 2015 | Identical |
| NF EN ISO 5840-2 : 2015 | Identical |
| NEN EN ISO 5840-2 : 2015 | Identical |
| NS EN ISO 5840-2 : 2015 | Identical |
| I.S. EN ISO 5840-2:2015 | Identical |
| PN EN ISO 5840-2 : 2016 | Identical |
| SN EN ISO 5840-2 : 2015 | Identical |
| UNI EN ISO 5840-2 : 2015 | Identical |
| UNE-EN ISO 5840-2:2016 | Identical |
| BS EN ISO 5840-2:2015 | Identical |
| EN ISO 5840-2:2015 | Identical |
| DIN EN ISO 5840-2:2016-05 | Identical |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| ASTM F 3211 : 2017 | Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| ONORM EN ISO 5840-1 : 2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 14160:2011 | Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 532:1975 | Acoustics Method for calculating loudness level |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60651:1979+AMD1:1993+AMD2:2000 CSV | Sound level meters |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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