ISO 5910:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
05-07-2024
English
31-05-2018
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1.1 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus).
1.2 This document outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological, and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system.
NOTE For the purposes of this document, effectiveness endpoint includes clinical performance and benefits.
1.3 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification.
1.4 This document excludes Cardiac Resynchronization Therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This Standard also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice).
NOTE A rationale for the provisions of this document is given in Annex A.
| Committee |
ISO/TC 150/SC 2
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| DevelopmentNote |
Supersedes ISO/DIS 5910. (06/2018)
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| DocumentType |
Standard
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| Pages |
126
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| ProductNote |
This Standard is also refer as ISO 5840‑2:2015,ISO 5840‑1:2015,ISO 5840‑3:2013,ISO 10555‑1,ISO 10993‑4:2017,ISO/TS 11139,ISO 25539‑1,ISO/IEC Guide 51:2014,IEC 60601‑1,ASTM F1830 – 97:2013,
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| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy | |
| UnderRevision |
| Standards | Relationship |
| IS 17745 : 2021 | Identical |
| DS/ISO 5910:2018 | Identical |
| BS ISO 5910:2018 | Identical |
| ISO/TR 22442-4:2010 | Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| 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 |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| 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 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 5840-3:2013 | Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| 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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