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AS ISO 7198-2003

AS ISO 7198-2003

Cardiovascular implants - Tubular vascular prostheses

Standards Australia

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Table of Contents

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)

Abstract

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.

Scope

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.

General Product Information

Document Type Standard
Status Current
Publisher Standards Australia
ProductNote Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Committee HE-012
Supersedes
  • DR 03105 CP

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