AS ISO 7198-2003

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)

Specifies requirements relating to testing, packaging, labelling and terminology for sterile tubular vascular prostheses intended to replace, bypass or to form shunts between segments of the vascular system in humans.

1.1 This International Standard specifies requirements relating to testing, packaging, labelling and terminology for sterile tubular vascular prostheses intended to replace, bypass or to form shunts between segments of the vascular system in humans.This International Standard addresses vascular prostheses that are made wholly or partly of: materials of biological origin; synthetic textile materials; and synthetic nontextile materials. In addition, guidance for characterization of compound and composite prostheses is provided. It specifies the designation of materials of manufacture and the construction, and specifies the designation of sizes and dimensions of vascular prostheses. It refers to biological requirements of the materials of construction and of the finished product, taking into account the appropriate part of the horizontal International Standard ISO 10993.This International Standard also specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties declared by the manufacturer. It refers to sterilization of prostheses and specifies requirements for labelling and packaging. It also provides definitions of terms in common use.1.2 This International Standard does not specify all the performance or dimensional characteristics, but it does include methods for verifying that the nominal values disclosed by the manufacturer are within the permitted tolerances. These recommendations do not purport to comprise a complete test program.1.3 For the purposes of this International Standard, the disclosure of test methods, results and other information on request shall relate solely to requests from a National Regulatory Authority with responsibility for surgical implants.This International Standard does not apply to human donor tissue devices such as cryopreserved vessels. Also excluded are all patches, pledgets and stents.

First published as AS ISO 7198-2003.