AAMI 25539 2 2012
$162.84
ANSI/AAMI/ISO 25539-2:2012 – Cardiovascular implants-Endovascular devices-Part 2: Vascular stents
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 116 |
Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 25539-2:2012, Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 25539-2:2012 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 17 | 4 General requirements 4.1 Classification 4.2 Size 4.3 Intended clinical use designation |
| 18 | 5 Intended performance 6 Design attributes 6.1 General |
| 19 | 6.2 Delivery system and stent system 6.3 Implant 6.3.1 Stent 6.3.2 Coating |
| 20 | 6.3.3 Drug 7 Materials 8 Design evaluation 8.1 General |
| 21 | 8.2 Sampling 8.3 Conditioning of test samples |
| 22 | 8.4 Reporting 8.5 Delivery system and stent system 8.5.1 Ability to access 8.5.1.1 General |
| 23 | 8.5.1.2 Bond strength 8.5.1.3 Component dimension compatibility 8.5.1.4 Dimensional verification 8.5.1.5 Dislodgement force (pre-mounted balloon expandable stents) |
| 24 | 8.5.1.6 Flex/kink 8.5.1.7 Profile/diameter test 8.5.1.8 Pushability 8.5.1.9 Simulated use 8.5.1.10 Torquability 8.5.1.11 Torsional bond strength 8.5.1.12 Trackability 8.5.1.13 Visibility 8.5.2 Ability to deploy 8.5.2.1 General |
| 25 | 8.5.2.2 Bond strength 8.5.2.3 Balloon inflation time (balloon expandable or balloon assisted stents) 8.5.2.4 Balloon deflation time (balloon expandable or balloon assisted stents) 8.5.2.5 Balloon rated burst pressure (RBP) (balloon expandable or balloon assisted stents) |
| 26 | 8.5.2.6 Balloon rated fatigue (balloon expandable stents) 8.5.2.7 Component dimension compatibility 8.5.2.8 Dimensional verification 8.5.2.9 Dislodgement force (pre-mounted balloon expandable stents) 8.5.2.10 Dogboning (balloon expandable stents) 8.5.2.11 Force to deploy (self-expanding stents) 8.5.2.12 Simulated use 8.5.2.13 Visibility 8.5.3 Ability to withdraw 8.5.3.1 General |
| 27 | 8.5.3.2 Bond strength 8.5.3.3 Component dimension compatibility 8.5.3.4 Dimensional verification |
| 28 | 8.5.3.5 Flex/kink 8.5.3.6 Simulated use 8.5.3.7 Torsional bond strength 8.5.3.8 Tubing tensile strength 8.5.3.9 Visibility 8.5.4 Biocompatibility 8.5.5 Hemostasis 8.5.5.1 General |
| 29 | 8.5.5.2 Component dimension compatibility 8.5.5.3 Dimensional verification 8.5.5.4 Assessment of hemostasis 8.6 Stent 8.6.1 Ability to accurately deploy 8.6.1.1 General |
| 30 | 8.6.1.2 Stent length-to-diameter relationship 8.6.1.3 Profile effect/flaring (balloon expandable stents) 8.6.1.4 Simulated use 8.6.1.5 Visibility 8.6.2 Fixation effectiveness 8.6.2.1 General |
| 31 | 8.6.2.2 Conformability to vessel wall 8.6.2.3 Crush resistance with a radially applied load (balloon expandable stents) 8.6.2.4 Crush resistance with parallel plates 8.6.2.5 Local compression 8.6.2.6 Radial force 8.6.2.7 Recoil (balloon expandable stents) 8.6.2.8 Simulated use 8.6.3 Stent integrity 8.6.3.1 General |
| 32 | 8.6.3.2 Acute coating integrity 8.6.3.3 Coating dimensions and other coating parameters (e.g. porosity, density distribution, mass) 8.6.3.4 Corrosion |
| 33 | 8.6.3.5 Durability 8.6.3.5.1 General 8.6.3.5.2 Stress/strain analyses 8.6.3.5.3 Fatigue safety factor determination 8.6.3.5.4 Fatigue durability testing |
| 34 | 8.6.3.5.5 Coating durability 8.6.3.5.6 Coating particulate generation 8.6.3.6 Visual inspection 8.6.4 Sizing 8.6.4.1 General |
| 35 | 8.6.4.2 Dimensional verification 8.6.4.3 Stent diameter to balloon inflation pressure (balloon expandable stents) 8.6.4.4 Recoil (balloon expandable stents) 8.6.4.5 Simulated use 8.6.4.6 Stent length to diameter relationship |
| 36 | 8.6.5 Patency 8.6.5.1 General |
| 37 | 8.6.5.2 Crush resistance test with a radially applied load (balloon expandable stents) 8.6.5.3 Crush resistance with parallel plates 8.6.5.4 Flex/kink 8.6.5.5 Local compression 8.6.5.6 Radial force 8.6.5.7 Simulated use 8.6.5.8 Stent-free surface area and stent outer surface area 8.6.6 Magnetic resonance imaging (MRI) safety and compatibility |
| 38 | 8.6.7 Biocompatibility 8.6.8 Drug elution 8.6.8.1 General |
| 39 | 8.6.8.2 Drug content/amount 8.6.8.3 Elution profile 8.6.8.4 Drug identity 8.7 Preclinical in vivo evaluation 8.7.1 Purpose 8.7.2 Specific aims |
| 40 | 8.7.3 Protocol 8.7.4 Data acquisition |
| 42 | 8.7.5 Test report and additional information |
| 43 | 8.8 Clinical evaluation 8.8.1 Purpose 8.8.2 Specific aims |
| 44 | 8.8.3 Clinical investigation plan 8.8.4 Data acquisition during clinical investigations |
| 46 | 8.8.5 Final report |
| 48 | 9 Post-market surveillance 10 Manufacturing 11 Sterilization 11.1 Products supplied sterile 11.2 Products supplied non-sterile 11.3 Sterilization residuals |
| 49 | 12 Packaging 12.1 Protection from damage in storage and transport 12.1.1 General 12.1.2 Unit container 12.1.3 Outer container 12.1.4 Shipping container 12.1.5 Maintenance of sterility in transit 12.2 Marking 12.2.1 Container label 12.2.2 Stents without delivery systems |
| 50 | 12.2.3 Stent systems (stents with delivery system) 12.2.4 Record label 12.3 Information supplied by the manufacturer 12.3.1 General |
| 51 | 12.3.2 Information and instructions for use (IFU) |
| 52 | Annex A (informative) Attributes of endovascular devices — Vascular stents — Technical and clinical consideration |
| 59 | Annex B (informative) Bench and analytical tests |
| 63 | Annex C (informative) Definitions of reportable clinical events |
| 66 | Annex D (informative) Test methods D.1 General D.2 Sampling |
| 67 | D.3 Conditioning of test samples D.4 Reporting |
| 68 | D.5 Test methods D.5.1 Stent system D.5.1.1 Dimensional verification and component dimension compatibility D.5.1.1.1 Purpose D.5.1.1.2 Materials D.5.1.1.3 Sampling D.5.1.1.4 Conditioning D.5.1.1.5 Test method |
| 69 | D.5.1.1.6 Expression of results D.5.1.1.7 Test report D.5.1.2 Profile/diameter test D.5.1.2.1 Purpose D.5.1.2.2 Materials D.5.1.2.3 Sampling |
| 70 | D.5.1.2.4 Conditioning D.5.1.2.5 Test method D.5.1.2.6 Expression of results D.5.1.2.7 Test report D.5.1.3 Simulated use D.5.1.3.1 Purpose D.5.1.3.2 Materials |
| 71 | D.5.1.3.3 Sampling D.5.1.3.4 Conditioning D.5.1.3.5 Test method D.5.1.3.6 Expression of results D.5.1.3.7 Test report |
| 72 | D.5.1.4 Visibility D.5.1.4.1 Purpose D.5.1.4.2 Materials D.5.1.4.3 Sampling D.5.1.4.4 Conditioning D.5.1.4.5 Test method D.5.1.4.6 Expression of results |
| 73 | D.5.1.4.7 Test report D.5.1.5 Force to deploy D.5.1.5.1 Purpose D.5.1.5.2 Materials D.5.1.5.3 Sampling D.5.1.5.4 Conditioning D.5.1.5.5 Test method |
| 74 | D.5.1.5.6 Expression of results D.5.1.5.7 Test report D.5.1.6 Balloon inflation and deflation time (balloon expandable or balloon assisted stents) D.5.1.6.1 Purpose D.5.1.6.2 Materials D.5.1.6.3 Sampling |
| 75 | D.5.1.6.4 Conditioning D.5.1.6.5 Test method D.5.1.6.6 Expression of results D.5.1.6.7 Test report D.5.1.7 Balloon rated burst pressure (RBP) (balloon expandable or balloon assisted stents) D.5.1.7.1 Purpose D.5.1.7.2 Materials |
| 76 | D.5.1.7.3 Sampling D.5.1.7.4 Conditioning D.5.1.7.5 Test method |
| 77 | D.5.1.7.6 Expression of results D.5.1.7.7 Test report D.5.1.8 Balloon rated fatigue (balloon expandable or balloon-assisted stents) D.5.1.8.1 Purpose D.5.1.8.2 Materials |
| 78 | D.5.1.8.3 Sampling D.5.1.8.4 Conditioning D.5.1.8.5 Test method D.5.1.8.6 Expression of results D.5.1.8.7 Test report |
| 79 | D.5.2 Delivery system D.5.2.1 Bond strength D.5.2.1.1 Purpose D.5.2.1.2 Materials D.5.2.1.3 Sampling D.5.2.1.4 Conditioning D.5.2.1.5 Test method D.5.2.1.6 Expression of results D.5.2.1.7 Test report |
| 80 | D.5.2.2 Torsional bond strength D.5.2.2.1 Purpose D.5.2.2.2 Materials D.5.2.2.3 Sampling D.5.2.2.4 Conditioning D.5.2.2.5 Test method D.5.2.2.6 Expression of results D.5.2.2.7 Test report |
| 81 | D.5.3 Stent D.5.3.1 Stent diameter to balloon inflation pressure D.5.3.1.1 Purpose D.5.3.1.2 Materials D.5.3.1.3 Sampling D.5.3.1.4 Conditioning D.5.3.1.5 Test method |
| 82 | D.5.3.1.6 Expression of results D.5.3.1.7 Test report D.5.3.2 Dimensional verification and stent length to diameter relationship D.5.3.2.1 Purpose D.5.3.2.2 Materials D.5.3.2.3 Sampling |
| 83 | D.5.3.2.4 Conditioning D.5.3.2.5 Test method D.5.3.2.6 Expression of results D.5.3.2.7 Test report |
| 84 | D.5.3.3 Recoil D.5.3.3.1 Purpose D.5.3.3.2 Materials D.5.3.3.3 Sampling D.5.3.3.4 Conditioning D.5.3.3.5 Test method |
| 85 | D.5.3.3.6 Expression of results D.5.3.3.7 Test report D.5.3.4 Crush resistance with radially applied load D.5.3.4.1 Purpose D.5.3.4.2 Materials |
| 86 | D.5.3.4.3 Sampling D.5.3.4.4 Conditioning D.5.3.4.5 Test method D.5.3.4.6 Expression of results D.5.3.4.7 Test report D.5.3.5 Crush resistance with parallel plates D.5.3.5.1 Purpose |
| 87 | D.5.3.5.2 Materials D.5.3.5.3 Sampling D.5.3.5.4 Conditioning D.5.3.5.5 Test method |
| 88 | D.5.3.5.6 Expression of results D.5.3.5.7 Test report D.5.3.6 Flex/kink D.5.3.6.1 Purpose D.5.3.6.2 Materials |
| 89 | D.5.3.6.3 Sampling D.5.3.6.4 Conditioning D.5.3.6.5 Test method A D.5.3.6.6 Test method B |
| 90 | D.5.3.6.7 Expression of results D.5.3.6.8 Test report D.5.3.7 Local compression D.5.3.7.1 Purpose |
| 91 | D.5.3.7.2 Materials D.5.3.7.3 Sampling D.5.3.7.4 Conditioning D.5.3.7.5 Test method D.5.3.7.6 Expression of results |
| 92 | D.5.3.7.7 Test report D.5.3.8 Radial force D.5.3.8.1 Purpose D.5.3.8.2 Materials D.5.3.8.3 Sampling |
| 93 | D.5.3.8.4 Conditioning D.5.3.8.5 Test method D.5.3.8.6 Expression of results D.5.3.8.7 Test report D.5.3.9 Corrosion assessment D.5.3.9.1 Purpose D.5.3.9.2 Materials |
| 94 | D.5.3.9.3 Sampling D.5.3.9.4 Conditioning D.5.3.9.5 Test method D.5.3.9.6 Expression of results D.5.3.9.7 Test report D.5.3.10 Fatigue durability test D.5.3.10.1 Purpose |
| 95 | D.5.3.10.2 Materials D.5.3.10.3 Sampling |
| 96 | D.5.3.10.4 Conditioning D.5.3.10.5 Test method |
| 99 | D.5.3.10.6 Expression of results |
| 100 | D.5.3.10.7 Test report D.5.3.11 Stress/strain analyses (e.g. finite element analysis) D.5.3.11.1 Purpose D.5.3.11.2 Materials D.5.3.11.3 Sampling D.5.3.11.4 Methodology of analysis |
| 101 | D.5.3.11.5 Expression of results D.5.3.11.6 Test report |
| 102 | D.5.3.12 Dislodgment force (premounted balloon-expandable stents) D.5.3.12.1 Purpose D.5.3.12.2 Materials D.5.3.12.3 Sampling D.5.3.12.4 Conditioning |
| 103 | D.5.3.12.5 Test method D.5.3.12.6 Expression of results D.5.3.12.7 Test report D.5.3.13 Dogboning (balloon expandable stents) D.5.3.13.1 Purpose D.5.3.13.2 Materials |
| 104 | D.5.3.13.3 Sampling D.5.3.13.4 Conditioning D.5.3.13.5 Test method D.5.3.13.6 Expression of results D.5.3.13.7 Test report |
| 105 | D.5.3.14 Profile effect/flaring D.5.3.14.1 Purpose D.5.3.14.2 Materials D.5.3.14.3 Sampling D.5.3.14.4 Conditioning D.5.3.14.5 Test method |
| 106 | D.5.3.14.6 Expression of results D.5.3.14.7 Test report D.5.3.15 Stent-free surface area and stent outer surface area D.5.3.15.1 Purpose D.5.3.15.2 Materials D.5.3.15.3 Sampling D.5.3.15.4 Methodology of analysis |
| 107 | D.5.3.15.5 Expression of results D.5.3.15.6 Test report D.5.3.16 Acute coating integrity D.5.3.16.1 Purpose D.5.3.16.2 Materials D.5.3.16.3 Sampling D.5.3.16.4 Conditioning |
| 108 | D.5.3.16.5 Test method D.5.3.16.6 Expression of results D.5.3.16.7 Test report |
| 109 | Annex E (informative) Supplement to fatigue durability test analytical approach E.1 Zero longitudinal strain (constant length) condition — Sample equations for calculation of the inner diameter (or radius) from the outer diameter (or radius) for the zero longitudinal strain (constant length) condition |
| 110 | E.2 Zero longitudinal stress (unconstrained length) condition — Sample equations for calculation of the inner diameter (or radius) from the outer diameter (or radius) for the zero longitudinal stress (unconstrained length) condition |
| 112 | Bibliography |
