BS EN ISO 5840-2:2015 – TC:2020 Edition
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Tracked Changes. Cardiovascular implants. Cardiac valve prostheses – Surgically implanted heart valve substitutes
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 186 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 124 | European foreword |
| 125 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices |
| 128 | Foreword |
| 129 | Introduction |
| 130 | 1 Scope 2 Normative references |
| 131 | 3 Terms and definitions |
| 133 | 4 Abbreviations 5 Fundamental requirements |
| 134 | 6 Device description 6.1 Intended use 6.2 Design inputs 6.2.1 Operational specifications 6.2.2 Performance specifications |
| 135 | 6.2.3 Packaging, labelling, and sterilization 6.3 Design outputs 6.3.1 General 6.4 Design transfer (manufacturing qualification) 6.5 Risk management 7 Design verification testing and analysis/design validation 7.1 General requirements |
| 136 | 7.2 In vitro assessment 7.2.1 Test conditions, sample selection, and reporting requirements |
| 137 | 7.2.2 Material property assessment 7.2.3 Hydrodynamic performance assessment |
| 139 | 7.2.4 Structural performance assessment |
| 140 | 7.2.5 Device MRI safety 7.2.6 Additional implant design evaluation requirements |
| 141 | 7.2.7 Design specific testing 7.2.8 Simulated use 7.2.9 Human factors/usability assessment 7.3 Preclinical in vivo evaluation 7.3.1 Overall requirements |
| 142 | 7.3.2 Methods |
| 143 | 7.3.3 Test report |
| 144 | 7.4 Clinical investigation 7.4.1 General 7.4.2 Statistical considerations 7.4.3 Distribution of subjects and investigators 7.4.4 Sample size |
| 145 | 7.4.5 Entry criteria 7.4.6 Duration of the study 7.4.7 Clinical data requirements |
| 147 | 7.4.8 Clinical investigation report |
| 149 | Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods |
| 152 | Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers |
| 154 | Annex C (informative) Preclinical in vivo evaluation |
| 157 | Annex D (informative) Description of the surgical heart valve substitute |
| 159 | Annex E (informative) Examples of components of some surgical heart valve substitutes |
| 163 | Annex F (informative) Guidelines for verification of hydrodynamic performance |
| 172 | Annex G (informative) Durability testing |
| 174 | Annex H (informative) Examples of design specific testing |
| 176 | Annex I (informative) Fatigue assessment |
| 182 | Annex J (normative) Methods of evaluating clinical data |
| 183 | Bibliography |
