1 - AS ISO 7198-2003 CARDIOVASCULAR IMPLANTS-TUBULAR VASCULAR PROSTHESES
4 - PREFACE
5 - CONTENTS
6 - INTRODUCTION
7 - 1 Scope
7 - 2 Normative references
8 - 3 Terms and definitions
8 - 3.1 allograft (adj.: alloplast)
8 - 3.2 bifurcation
8 - 3.3 biological material
8 - 3.4 biostability
8 - 3.5 coating
8 - 3.6 compliance
8 - 3.7 component
9 - 3.8 composite prosthesis
9 - 3.9 compound prosthesis
9 - 3.10 configuration
9 - 3.11 construction
9 - 3.12 crimp
9 - 3.13 fibril
9 - 3.14 host
9 - 3.15 implantable state
9 - 3.16 integral water permeability
9 - 3.17 leakage
10 - 3.18 node
10 - 3.19 porosity
10 - 3.20 preclotting
10 - 3.21 primary component
10 - 3.22 prosthesis (plural: prostheses, adj.: prosthetic)
10 - 3.23 residual material
10 - 3.24 secondary component
10 - 3.25 substrate prosthesis
10 - 3.26 synthetic material
10 - 3.27 synthetic nontextile prosthesis
10 - 3.28 synthetic textile prosthesis
11 - 3.29 usable length
11 - 3.30 vascular prosthesis
11 - 3.31 velour
11 - 3.32 void
11 - 3.33 water entry pressure
11 - 3.34 water permeability
11 - 3.35 xenograft (adj.: xenoplast)
11 - 4 General requirements
11 - 4.1 Configuration and size designation
11 - 4.1.1 Uniform straight vascular prostheses
12 - 4.1.2 Bifurcated uniform vascular prostheses
12 - 4.1.3 Tapered vascular prostheses
12 - 4.1.4 Other configurations
12 - 4.2 Intended clinical use designation
12 - 4.3 Materials and construction
12 - 4.3.1 Classification
12 - 4.3.2 Nomenclature
13 - 4.4 Biocompatibility and biostability
13 - 4.4.1 Biocompatibility
14 - 4.4.2 Biostability
14 - 4.5 Sterility
14 - 4.6 General information and instructions for use
14 - 4.7 Packaging
14 - 4.7.1 Unit container
15 - 4.7.2 Outer container
15 - 4.7.3 Shipping container
15 - 4.8 Marking
15 - 4.8.1 Container label
15 - 4.8.2 Record label
16 - 4.9 Test reports
16 - 4.9.1 General
16 - 4.9.2 Additional information
16 - 5 Requirements for finished prosthesis
17 - 5.1 Visual inspection
18 - 5.2 Porosity, water permeability, integral water permeability/leakage, and water entry pressure
18 - 5.2.1 Porosity
18 - 5.2.2 Water permeability
18 - 5.2.3 Integral water permeability/leakage
18 - 5.2.4 Water entry pressure
18 - 5.3 Strength
19 - 5.4 Length
19 - 5.5 Relaxed internal diameter
19 - 5.6 Pressurized internal diameter
19 - 5.7 Wall thickness
19 - 5.8 Suture retention strength
19 - 5.9 Kink diameter/radius
19 - 5.10 Compliance
20 - 6 Requirements for in vivo preclinical and clinical evaluation
20 - 6.1 In vivo preclinical testing
20 - 6.2 Clinical evaluation
21 - 7 Sampling
21 - 7.1 Sampling for characterization
21 - 7.2 Sampling for quality control
21 - 7.2.1 Random sampling
21 - 7.2.2 Time interval sampling
21 - 7.2.3 Number of samples
22 - 8 Test methods for vascular prostheses
22 - 8.1 Visual inspection
22 - 8.1.1 Principle
22 - 8.1.2 Apparatus
22 - 8.1.3 Sampling
22 - 8.1.4 Test procedure
22 - 8.1.5 Expression of results
22 - 8.1.6 Test reports and additional information
22 - 8.2 Determination of porosity, water permeability, integral water permeability/leakage, and water entry pressure
22 - 8.2.1 Determination of porosity
26 - 8.2.2 Determination of water permeability
29 - 8.2.3 Determination of integral water permeability/leakage
30 - 8.2.4 Determination of water entry pressure
30 - 8.3 Determination of strength
30 - 8.3.1 Determination of circumferential tensile strength
32 - 8.3.2 Determination of longitudinal tensile strength
33 - 8.3.3 Determination of burst strength
37 - 8.3.4 Determination of strength after repeated puncture (A, if applicable)
39 - 8.4 Determination of usable length (A)
39 - 8.4.1 Principle
39 - 8.4.2 Apparatus
39 - 8.4.3 Sampling
39 - 8.4.4 Test procedure
39 - 8.4.5 Expression of results
39 - 8.4.6 Test report and additional information
39 - 8.5 Determination of relaxed internal diameter
39 - 8.5.1 Principle
40 - 8.5.2 Apparatus
40 - 8.5.3 Sampling
41 - 8.5.4 Test procedure
41 - 8.5.5 Expression of results
41 - 8.5.6 Test report and additional information
41 - 8.6 Determination of pressurized internal diameter
41 - 8.6.1 Principle
41 - 8.6.2 Apparatus
41 - 8.6.3 Sampling
42 - 8.6.4 Test procedure
42 - 8.6.5 Expression of results
43 - 8.6.6 Test report and additional information
43 - 8.7 Determination of wall thickness
43 - 8.7.1 Principle
43 - 8.7.2 Apparatus
43 - 8.7.3 Sampling
43 - 8.7.4 Test procedure
44 - 8.7.5 Expression of results
44 - 8.7.6 Test report and additional information
44 - 8.8 Determination of suture retention strength
44 - 8.8.1 Principle
44 - 8.8.2 Apparatus
45 - 8.8.3 Sampling
45 - 8.8.4 Test procedure
45 - 8.8.5 Expression of results
45 - 8.8.6 Test report and additional information
45 - 8.9 Determination of kink diameter/radius
45 - 8.9.1 Principle
45 - 8.9.2 Apparatus
45 - 8.9.3 Sampling
45 - 8.9.4 Test procedure
46 - 8.9.5 Expression of results
46 - 8.9.6 Test report and additional information
46 - 8.10 Determination of dynamic compliance
46 - 8.10.1 Principle
46 - 8.10.2 Apparatus
46 - 8.10.3 Sampling
47 - 8.10.4 Test procedure
47 - 8.10.5 Expression of results
47 - 8.10.6 Test report and additional information
48 - 9 In vivo preclinical and clinical test methods for vascular prostheses
48 - 9.1 Trial design, data acquisition and data analysis for in vivo preclinical animal studies
48 - 9.1.1 Principle
48 - 9.1.2 Protocol
48 - 9.1.3 Data acquisition
49 - 9.1.4 Test report and additional information
49 - 9.2 Trial design, data acquisition and data analysis for clinical evaluation
49 - 9.2.1 Principle
49 - 9.2.2 Protocol
50 - 9.2.3 Data acquisition
52 - 9.2.4 Test report
53 - 10 Information to be recorded and disclosed by the manufacturer on request
53 - 10.1 General
53 - 10.2 Conformity to general requirements (see clause 4)
53 - 10.3 Conformity to requirements for finished product (see clause 5)
54 - 10.4 Conformity to requirements for in vivo testing and clinical evaluation (see clause 6)