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ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches >
ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches, 2016
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 4.1 Configuration designation for tubular vascular grafts
- 4.2 Size designation
- 4.2.1 Uniform straight tubular vascular grafts
- 4.2.2 Uniform bifurcated tubular vascular grafts
- 4.2.3 Tapered tubular vascular grafts
- 4.2.4 Other configurations of tubular vascular grafts
- 4.2.5 Vascular patches
- 4.3 Materials
- 4.3.1 General
- 4.3.2 Classification of tubular vascular grafts and vascular patches
- 4.3.3 Nomenclature
- 4.4 Intended clinical use designation
- 5 Intended performance
- 6 Design attributes
- 6.1 General
- 6.2 Tubular vascular grafts
- 6.3 Vascular patches
- 6.4 Coatings
- 6.5 Drug coatings and drug-eluting coatings
- 7 Materials
- 8 Design evaluation
- 8.1 General
- 8.2 Sampling
- 8.3 Conditioning of test samples
- 8.4 Reporting
- 8.5 Biocompatibility
- 8.5.1 Residual chemicals
- 8.5.2 Biocompatibility
- 8.6 Biostability
- 8.7 Bench and analytical tests
- 8.7.1 General
- 8.7.2 Tubular vascular grafts
- 8.7.3 Vascular patches
- 9 Preclinical in vivo evaluation test methods for vascular prostheses
- 9.1 Preclinical in vivo evaluation
- 9.1.1 Purpose
- 9.1.2 Specific aims
- 9.1.3 Protocol considerations
- 9.1.4 Data acquisition
- 9.1.5 Test report and additional information
- 10 Clinical investigation methods for vascular prostheses
- 10.1 Clinical investigation
- 10.1.1 Purpose
- 10.1.2 Specific aims
- 10.1.3 Protocol considerations
- 10.1.4 Data acquisition
- 10.1.5 Final report
- 10.2 Post market surveillance
- 11 Manufacturing
- 12 Sterility
- 13 Packaging and labelling
- 13.1 General
- 13.2 Unit container
- 13.3 Outer container
- 13.4 Shipping container
- 13.5 Maintenance of sterility in transit
- 13.6 Marking
- 13.6.1 Container label
- 13.6.2 Record label
- 13.6.3 General information and instructions for use
- Annex A (informative) Test methods
- Bibliography [Go to Page]