BS ISO 5910:2018
$215.11
Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 136 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 7 | Foreword |
| 8 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 19 | 4 Abbreviations |
| 20 | 5 Fundamental requirements 5.1 General 5.2 Risk management |
| 21 | 6 Device description 6.1 Intended use/Indication for use 6.2 Design inputs 6.2.1 General 6.2.2 Operational specifications |
| 22 | 6.2.3 Functional, performance and safety requirements |
| 23 | 6.2.4 Usability |
| 24 | 6.2.5 Packaging, labelling, and sterilization 6.3 Design outputs 6.4 Design transfer (manufacturing verification/validation) 7 Design verification testing and analysis / Design validation 7.1 General requirements 7.2 In vitro assessment 7.2.1 General |
| 25 | 7.2.2 Test articles, sample selection, test conditions and reporting requirements |
| 26 | 7.2.3 Device material property assessment |
| 27 | 7.2.4 Functional performance assessment 7.2.5 Device structural performance assessment |
| 28 | 7.2.6 Device corrosion assessment 7.2.7 Delivery system design evaluation requirements 7.2.8 Visibility 7.2.9 Simulated use assessment |
| 29 | 7.2.10 Human factors / Usability assessment 7.2.11 Device MRI safety 7.2.12 Design specific testing 7.3 Preclinical in vivo evaluation 7.3.1 General 7.3.2 Overall requirements |
| 31 | 7.3.3 Methods |
| 32 | 7.3.4 Test report 7.4 Clinical Investigations 7.4.1 General |
| 33 | 7.4.2 Study considerations |
| 36 | 7.4.3 Study endpoints 7.4.4 Ethical considerations 7.4.5 Distribution of subjects and investigators |
| 37 | 7.4.6 Statistical considerations including sample size and duration |
| 39 | 7.4.7 Patient selection criteria 7.4.8 Clinical data requirements |
| 42 | 7.4.9 Clinical investigation analysis and reporting 7.4.10 Post-market clinical follow-up |
| 44 | Annex A (informative) Rationale for the provisions of this document |
| 47 | Annex B (informative) Examples of heart valve repair devices and delivery systems |
| 53 | Annex C (normative) Packaging |
| 54 | Annex D (normative) Product labels, instructions for use, and training |
| 57 | Annex E (normative) Sterilization |
| 58 | Annex F (informative) Heart valve repair system characteristics |
| 60 | Annex G (informative) Heart valve repair system hazards, associated failure modes and evaluation methods |
| 71 | Annex H (informative) In vitro test guidelines for paediatric devices |
| 73 | Annex I (informative) Examples and definitions of some physical and material properties of heart valve repair device components |
| 87 | Annex J (informative) Examples of standards applicable to testing of materials and components of heart valve repair devices |
| 93 | Annex K (informative) Considerations for device material properties undergoing alterations post implantation |
| 94 | Annex L (informative) Corrosion assessment |
| 97 | Annex M (informative) Guidelines for in vitro evaluation of functional performance of the repair |
| 103 | Annex N (informative) Durability testing |
| 105 | Annex O (informative) Fatigue assessment |
| 111 | Annex P (informative) Preclinical in vivo evaluation |
| 114 | Annex Q (normative) Adverse event classification during clinical investigation |
| 120 | Annex R (informative) Imaging protocol |
| 124 | Annex S (informative) Clinical investigation endpoints for valve repair devices: Suggestions for endpoints and their timing |
| 128 | Annex T (informative) Additional device design evaluation requirements |
| 130 | Annex U (informative) Guidelines for delivery system design evaluation |
| 132 | Bibliography |
