AAMI 25539 3 2011 RA 2015
$162.84
ANSI/AAMI/ISO 25539-3:2011/(R)2015 – Cardiovascular implants-Endovascular devices-Part 3: Vena Cava Filters.
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 116 |
Specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 25539-3:2011/(R)2015, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| 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 |
| 9 | Committee representation |
| 10 | Background of AAMI adoption of ISO 25539-3:2011 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 17 | 4 General requirements 4.1 Classification 4.2 Size 5 Intended performance 6 Design attributes 6.1 General 6.2 Sheath/dilator kit for endovascular filter system |
| 18 | 6.3 Filter system 6.4 Filter 6.5 Optional filter 6.6 Sheath/dilator kit for endovascular retrieval/conversion system |
| 19 | 6.7 Retrieval/conversion system 6.8 Endovascular systems 7 Materials 8 Design evaluation 8.1 General |
| 20 | 8.2 Sampling 8.3 Conditioning of test samples 8.4 Reporting |
| 21 | 8.5 Bench and analytical tests |
| 22 | 8.5.1 Sheath/dilator kit for endovascular filter system 8.5.1.1 General |
| 23 | 8.5.1.2 Catheter burst 8.5.1.3 Dimensional verification and component dimensional compatibility 8.5.1.4 Power injection 8.5.1.5 Simulated use 8.5.1.5.1 General 8.5.1.5.2 Ability to access 8.5.1.5.2.1 Flex/kink 8.5.1.5.2.2 Pushability 8.5.1.5.2.3 Trackability 8.5.1.5.3 Ability to withdraw 8.5.1.6 Tensile strength |
| 24 | 8.5.1.7 Torsional bond strength 8.5.2 Filter system 8.5.2.1 General |
| 26 | 8.5.2.2 Dimensional verification and component dimensional compatibility 8.5.2.3 Force to deploy 8.5.2.4 Simulated use 8.5.2.4.1 General 8.5.2.4.2 Ability to deliver 8.5.2.4.3 Ability to deploy 8.5.2.4.3.1 Deployment accuracy 8.5.2.4.3.2 Deployed configuration 8.5.2.4.4 Ability to withdraw 8.5.2.5 Tensile strength 8.5.2.6 Torsional bond strength |
| 27 | 8.5.3 Filter 8.5.3.1 General |
| 28 | 8.5.3.2 Clot trapping 8.5.3.3 Corrosion 8.5.3.4 Durability 8.5.3.4.1 General 8.5.3.4.2 Stress/strain analyses 8.5.3.4.3 Fatigue |
| 29 | 8.5.3.5 Filter dimensional verification 8.5.3.6 Filter tensile strength 8.5.3.7 Migration resistance 8.5.3.8 Magnetic resonance imaging (MRI) compatibility 8.5.3.9 Radial force 8.5.3.10 Visual inspection 8.5.4 Optional filter 8.5.4.1 General |
| 31 | 8.5.4.2 Filter tensile strength 8.5.4.3 Force to retrieve/convert 8.5.4.4 Simulated use 8.5.4.4.1 General 8.5.4.4.2 Ability to engage 8.5.4.4.3 Ability to retrieve 8.5.4.4.4 Ability to convert 8.5.5 Sheath/dilator kit for endovascular retrieval/conversion system 8.5.5.1 General |
| 32 | 8.5.5.2 Catheter burst 8.5.5.3 Dimensional verification and component dimensional compatibility 8.5.5.4 Power injection 8.5.5.5 Simulated use 8.5.5.5.1 General 8.5.5.5.2 Ability to access |
| 33 | 8.5.5.5.2.1 Flex/kink 8.5.5.5.2.2 Pushability 8.5.5.5.2.3 Trackability 8.5.5.5.3 Ability to withdraw 8.5.5.6 Tensile strength 8.5.5.7 Torsional bond strength 8.5.6 Retrieval/conversion system 8.5.6.1 General |
| 35 | 8.5.6.2 Dimensional verification and component dimensional compatibility 8.5.6.3 Force to retrieve/convert 8.5.6.4 Simulated use 8.5.6.4.1 General 8.5.6.4.2 Ability to deliver 8.5.6.4.3 Ability to engage 8.5.6.4.4 Ability to retrieve 8.5.6.4.5 Ability to convert 8.5.6.4.6 Ability to withdraw 8.5.6.5 Torsional bond strength |
| 36 | 8.5.6.6 Tensile strength 8.5.7 Endovascular systems 8.5.7.1 General 8.5.7.2 Biocompatibility |
| 37 | 8.5.7.3 Visibility 8.6 Preclinical in vivo evaluation 8.6.1 Purpose 8.6.2 Specific aims |
| 38 | 8.6.3 Protocol 8.6.4 Data acquisition |
| 40 | 8.6.5 Test report and additional information |
| 41 | 8.7 Clinical evaluation 8.7.1 Purpose 8.7.2 Specific aims |
| 42 | 8.7.3 Clinical investigation plan |
| 43 | 8.7.4 Data acquisition |
| 45 | 8.7.5 Final report |
| 46 | 9 Post-market surveillance 10 Manufacturing 11 Sterilization 11.1 Products supplied sterile |
| 47 | 11.2 Products supplied non-sterile 11.3 Sterilization residuals 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 |
| 48 | 12.2 Marking 12.2.1 Container label 12.2.2 Filters without deployment systems 12.2.3 Endovascular filter systems |
| 49 | 12.2.4 Endovascular retrieval/conversion system 12.2.5 Record label 12.3 Information supplied by the manufacturer 12.3.1 General 12.3.2 Information and instructions for use (IFU) |
| 51 | Annex A (informative) Attributes of endovascular devices — Vena cava filters — Technical and clinical considerations A.1 General |
| 65 | Annex B (informative) Descriptions of potential device effects of failure and failure modes and descriptions of detrimental clinical effects B.1 General |
| 70 | Annex C (informative) Bench and analytical tests C.1 General |
| 74 | Annex D (informative) Test methods D.1 General D.2 Sampling |
| 75 | D.3 Conditioning of test samples D.4 Reporting |
| 76 | D.5 Test methods |
| 77 | D.5.1 Endovascular filter 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 |
| 78 | D.5.1.1.6 Expression of results D.5.1.1.7 Test report D.5.1.2 Simulated use (endovascular filter system) D.5.1.2.1 Purpose D.5.1.2.2 Materials D.5.1.2.3 Sampling D.5.1.2.4 Conditioning |
| 79 | 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 Force to deploy D.5.1.3.1 Purpose |
| 80 | D.5.1.3.2 Materials 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 |
| 81 | D.5.1.3.7 Test report 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 |
| 82 | D.5.1.4.6 Expression of results D.5.1.4.7 Test report D.5.2 Filter D.5.2.1 Clot trapping D.5.2.1.1 Purpose D.5.2.1.2 Materials D.5.2.1.3 Sampling |
| 83 | 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 D.5.2.2 Fatigue/durability D.5.2.2.1 Purpose |
| 84 | D.5.2.2.2 Materials |
| 85 | D.5.2.2.3 Sampling D.5.2.2.4 Conditioning D.5.2.2.5 Test method |
| 86 | D.5.2.2.6 Expression of results D.5.2.2.7 Test report |
| 87 | D.5.2.3 Filter dimensional verification D.5.2.3.1 Purpose D.5.2.3.2 Materials D.5.2.3.3 Sampling D.5.2.3.4 Conditioning D.5.2.3.5 Test method D.5.2.3.6 Expression of results D.5.2.3.7 Test report |
| 88 | D.5.2.4 Filter tensile strength D.5.2.4.1 Purpose D.5.2.4.2 Materials D.5.2.4.3 Sampling D.5.2.4.4 Conditioning D.5.2.4.5 Test method D.5.2.4.6 Expression of results D.5.2.4.7 Test report D.5.2.5 Migration resistance D.5.2.5.1 Purpose |
| 89 | D.5.2.5.2 Materials D.5.2.5.3 Sampling D.5.2.5.4 Conditioning D.5.2.5.5 Test method |
| 90 | D.5.2.5.6 Expression of results D.5.2.5.7 Test report D.5.2.6 Radial force D.5.2.6.1 Purpose D.5.2.6.2 Materials |
| 91 | D.5.2.6.3 Sampling D.5.2.6.4 Conditioning D.5.2.6.5 Test method D.5.2.6.6 Expression of results D.5.2.6.7 Test report D.5.2.7 Stress/strain analyses D.5.2.7.1 Purpose D.5.2.7.2 Materials |
| 92 | D.5.2.7.3 Sampling D.5.2.7.4 Methodology of analysis |
| 93 | D.5.2.7.5 Expression of results D.5.2.7.6 Test report D.5.2.8 Visual inspection D.5.2.8.1 Purpose D.5.2.8.2 Materials D.5.2.8.3 Sampling D.5.2.8.4 Conditioning D.5.2.8.5 Test method |
| 94 | D.5.2.8.6 Expression of results D.5.2.8.7 Test report D.5.3 Delivery system D.5.3.1 Tensile strength 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 D.5.3.1.6 Expression of results |
| 95 | D.5.3.1.7 Test report D.5.3.2 Torsional bond strength D.5.3.2.1 Purpose D.5.3.2.2 Materials D.5.3.2.3 Sampling D.5.3.2.4 Conditioning D.5.3.2.5 Test method |
| 96 | D.5.3.2.6 Expression of results D.5.3.2.7 Test report D.5.4 Sheath/dilator kit for endovascular filter system D.5.4.1 Catheter burst D.5.4.1.1 Purpose D.5.4.1.2 Materials D.5.4.1.3 Sampling D.5.4.1.4 Conditioning D.5.4.1.5 Test method |
| 97 | D.5.4.1.6 Expression of results D.5.4.1.7 Test report D.5.4.2 Power injection D.5.4.2.1 Purpose D.5.4.2.2 Materials D.5.4.2.3 Sampling D.5.4.2.4 Conditioning |
| 98 | D.5.4.2.5 Test method D.5.4.2.6 Expression of results D.5.4.2.7 Test report D.5.4.3 Tensile strength D.5.4.3.1 Purpose D.5.4.4 Torsional bond strength D.5.4.4.1 Purpose |
| 99 | D.5.5 Endovascular retrieval/conversion system D.5.5.1 Dimensional verification and component dimensional compatibility D.5.5.1.1 Purpose D.5.5.2 Simulated use (endovascular retrieval/conversion system) D.5.5.2.1 Purpose D.5.5.2.2 Materials D.5.5.2.3 Sampling D.5.5.2.4 Conditioning |
| 100 | D.5.5.2.5 Test method D.5.5.2.6 Expression of results D.5.5.2.7 Test report D.5.5.3 Force to retrieve/convert D.5.5.3.1 Purpose D.5.5.3.2 Materials |
| 101 | D.5.5.3.3 Sampling D.5.5.3.4 Conditioning D.5.5.3.5 Test method D.5.5.3.6 Expression of results D.5.5.3.7 Test report |
| 102 | D.5.5.4 Visibility D.5.5.4.1 Purpose D.5.6 Retrieval/conversion system D.5.6.1 Tensile strength D.5.6.1.1 Purpose D.5.6.2 Torsional bond strength D.5.6.2.1 Purpose D.5.7 Sheath/dilator kit for endovascular retrieval/conversion system D.5.7.1 Catheter burst D.5.7.1.1 Purpose D.5.7.2 Power injection D.5.7.2.1 Purpose |
| 103 | D.5.7.3 Tensile strength D.5.7.3.1 Purpose D.5.7.4 Torsional bond strength D.5.7.4.1 Purpose |
| 104 | Annex E (informative) Examples of terms for clinical use of vena cava filters |
| 106 | Bibliography |
