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eLibrary > ANSI/AAMI/ISO 25539-1:2017 - Cardiovascular implants- Endovascular devices-Part 1: Endovascular prostheses >

ANSI/AAMI/ISO 25539-1:2017 - Cardiovascular implants- Endovascular devices-Part 1: Endovascular prostheses, 2017

ANSI/AAMI/ISO 25539-1:2017; Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses
Objectives and uses of AAMI standards andrecommended practices
Title page
AAMI Standard
Copyright information
Contents
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 25539-1:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for endovascular system [Go to Page]
4.1 Type of endovascular prosthesis
4.2 Materials and construction for endovascular system
4.3 Configuration and size designation for endovascular prosthesis
4.4 Intended clinical use for endovascular system
4.5 Balloon designation
5 Intended performance
6 Design attributes [Go to Page]
6.1 General
6.2 Endovascular system
6.3 Endovascular prosthesis
6.4 Endovascular system and endovascular prosthesis
7 Materials
8 Design evaluation [Go to Page]
8.1 General
8.2 Sampling
8.3 Conditioning of test samples
8.4 Reporting
8.5 Bench and analytical tests [Go to Page]
8.5.1 Endovascular system and delivery system [Go to Page]
8.5.1.1 Balloon testing [Go to Page]
8.5.1.1.1 Balloon burst pressure for non-compliant balloons
8.5.1.1.2 Balloon deflation times
8.5.1.1.3 Balloon rated fatigue
8.5.1.1.4 Balloon volume to burst for compliant balloons
8.5.1.2 Dimensional verification of the endovascular system
8.5.1.3 Dislodgement force (pre-mounted, balloon-expandable endovascular prosthesis)
8.5.1.4 Force to deploy for self-expanding endovascular prostheses
8.5.1.5 Simulated use
8.5.1.6 Tensile bond strength
8.5.1.7 Torsional bond strength
8.5.1.8 Haemostasis
8.5.1.9 Biocompatibility
8.5.1.10 Sterilization assurance
8.5.1.11 Visibility
8.5.2 Endovascular prosthesis [Go to Page]
8.5.2.1 Corrosion
8.5.2.2 Fatigue and durability—Computational analyses
8.5.2.3 Fatigue and durability—in vitro testing [Go to Page]
8.5.2.3.1 General considerations
8.5.2.3.2 Radial fatigue and durability
8.5.2.3.3 Active fixation fatigue and durability
8.5.2.3.4 Axial fatigue and durability
8.5.2.3.5 Bending fatigue and durability
8.5.2.3.6 Torsional fatigue and durability
8.5.2.4 Fixation and seal [Go to Page]
8.5.2.4.1 Leakage at seal zone
8.5.2.4.2 Migration resistance
8.5.2.4.3 Separation force for overlapping endovascular prostheses
8.5.2.5 Patency-related tests [Go to Page]
Table 1—Rationale for crush and compression resistance and radial force requirements
8.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, non-aortic endovascular prostheses)
8.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable, non-aortic endovascular prostheses)
8.5.2.5.3 Crush resistance with radially applied load (balloon-expandable endovascular prostheses)
8.5.2.5.4 Radial force (self-expanding endovascular prostheses)
8.5.2.5.5 Resistance to kinking (flexibility)
8.5.2.6 Permeability [Go to Page]
8.5.2.6.1 Integral water leakage
8.5.2.6.2 Porosity (non-textile materials)
8.5.2.6.3 Water entry pressure (non-textile materials)
8.5.2.6.4 Water permeability (textile materials)
8.5.2.7 Sizing-related testing [Go to Page]
8.5.2.7.1 Dimensional verification of the endovascular prosthesis
8.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable endovascular prostheses)
8.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have clinically relevant length changes with diameter changes)
8.5.2.7.4 Recoil (balloon-expandable endovascular prostheses)
8.5.2.8 Strength [Go to Page]
8.5.2.8.1 Burst strength
8.5.2.8.2 Factory seam strength (endovascular prostheses with seams in the graft material)
8.5.2.8.3 Longitudinal tensile strength
8.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular access)
8.5.2.8.5 Strength of the connection(s) between the graft material and a discrete fixation system(s)
8.5.2.9 Magnetic resonance imaging (MRI) safety
8.6 Preclinical in vivo evaluation [Go to Page]
8.6.1 Purpose
8.6.2 Specific aims
8.6.3 Protocol considerations
8.6.4 Data acquisition
8.6.5 Test report and additional information
8.7 Clinical evaluation [Go to Page]
8.7.1 Purpose
8.7.2 Specific aims
8.7.3 Protocol considerations
8.7.4 Data acquisition
8.7.5 Final report
9 Post-market surveillance
10 Manufacturing
11 Sterilization [Go to Page]
11.1 Products supplied sterile
11.2 Sterilization residuals
12 Packaging [Go to Page]
12.1 Protection from damage in storage and transport [Go to Page]
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 Labelling [Go to Page]
12.2.1 Container label
12.2.2 Record label
12.3 Instructions for use [Go to Page]
12.3.1 General
12.3.2 Information and instructions for use for endovascular systems
Annex A (informative) Relationship between testing requirements and device attributes and potential failure modes [Go to Page]
Table A.1—Table headings and explanations for Tables A.3 and A.4 and for a device-specific DESa
Table A.2—Legend for grouped associated clinical effects of failure
Table A.3—Device evaluation strategy for the endovascular system
Table A.4—Device evaluation strategy for endovascular prosthesis
Table A.5—Design comparison between a previously evaluated device and the modified device
Table A.6—Indication for use comparison of a previously evaluated device and the study devicea
Table A.7—Device evaluation strategy for device design modifications and/or changes in intended use
Annex B (informative) Description of clinical and device effects of failure [Go to Page]
Table B.1—Description of clinical effects of failure
Table B.2—Description of device effects of failure
Annex C (informative) Bench and analytical tests [Go to Page]
Table C.1—Bench and analytical tests
Annex D (informative) Test methods [Go to Page]
Table D.1—Index of test methods
Figure D.1—Determination of outward force
Bibliography [Go to Page]

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