AAMI TIR17137 2014
$93.55
AAMI/ISO TIR17137:2014 – Cardiovascular implants and extracorporeal systems-Cardiovascular absorbable implants
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 38 |
Outlines design verification and validation considerations for absorbable cardiovascular implants. Applies to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO TIR17137:2014, Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background on ANSI/AAMI adoption of ISO/TS 17137:2014 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Implant considerations 4.1 Classification 4.2 Intended clinical performance 4.3 Intended clinical use |
| 16 | 4.4 Materials 4.5 Packaging, labelling, and sterilization 4.5.1 Packaging 4.5.1.1 General 4.5.1.2 Considerations for absorbable product 4.5.2 Labelling 4.5.2.1 Label(s) |
| 17 | 4.5.2.2 Instructions for use (IFU) |
| 18 | 4.5.3 Sterilization 4.5.3.1 General 4.5.3.2 Radiation sterilization 4.5.3.3 Ethylene oxide sterilization 4.5.3.4 Steam sterilization 4.5.3.5 Alternative sterilization |
| 19 | 4.6 Risk management 4.6.1 General 4.6.2 Failure modes 4.6.3 Risk mitigation 4.6.4 Specific aspects for absorbable implants |
| 20 | Figure 1 — Life cycle of one single device/implant 5 Design verification and validation — Testing and analysis 5.1 Overview |
| 21 | Figure 2 — Schematic representation of stages in the degradation of an absorbable implant 5.2 Considerations in the characterization and assessment of material and implant properties 5.2.1 General considerations |
| 23 | 5.2.2 Drug-substrate Interaction considerations 5.2.3 Summary of in vitro evaluation steps |
| 24 | 5.3 in vitro procedural assessment 5.3.1 Conditioning of test samples 5.3.2 Assessment of delivery and placement |
| 25 | 5.3.3 Assessment of initial function post-deployment 5.4 in vitro degradation assessment (post procedure) 5.4.1 General |
| 26 | 5.4.2 Implant integrity 5.4.2.1 Mechanical evaluation 5.4.2.2 Cyclic fatigue durability 5.4.2.3 Physical characterization of degradation/corrosion |
| 27 | 5.4.2.4 Material composition assessment 5.4.2.5 Other property assessments 5.4.2.5.1 Corrosion/degradation 5.4.2.5.2 Evaluate clinically using relevant imaging modalities |
| 28 | 5.4.2.5.3 Radiopacity 5.4.2.5.4 MRI compatibility 5.5 in vitro-in vivo correlation (IVIVC) 5.6 Biocompatibility 5.6.1 General considerations |
| 29 | 5.6.2 Sterilization considerations 5.6.3 Drug-device combination product considerations 5.7 Pre-clinical in vivo evaluation 5.7.1 Purpose |
| 30 | 5.7.2 Specific aims 5.7.3 Protocol |
| 32 | 5.7.4 Data acquisition 5.7.5 Test report and additional information 5.8 Clinical considerations specific to absorbable implants 5.8.1 Purpose 5.8.2 Specific aims 5.8.3 Clinical-investigation plan |
| 33 | 5.8.4 Data acquisition 5.8.5 Final report 5.8.6 Post market surveillance 5.9 Shelf life considerations 5.9.1 General information |
| 34 | 5.9.2 Real time aging 5.9.3 Accelerated aging |
| 35 | Annex A: Nomenclature of absorb, degrade and related terms |
| 36 | Bibliography |
