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BS EN ISO 7198:2017

BS EN ISO 7198:2017

$198.66

Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches

Published By Publication Date Number of Pages
BSI 2017 70
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1.1 This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard. This International Standard can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.

NOTE Due to the variations in the design of implants covered by this International Standard and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this International Standard will be necessary.

1.2 This International Standard is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.

1.3 Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of this International Standard.

1.4 While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, this International Standard does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.

1.5 Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of this standard.

1.6 Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of this International Standard. This International Standard includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539-1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).

NOTE Requirements for endovascular prostheses are specified in ISO 25539-1.

1.7 The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of this International Standard. This International Standard can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.

1.8 Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of this International Standard.

NOTE Requirements for vascular stents are specified in ISO 25539-2.

1.9 Requirements regarding cell seeding are excluded from the scope of this International Standard. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in this International Standard can be a useful guide for certain testing requirements for these cell-based products.

1.10 Pharmacological aspects of drug-eluting or drug-coated vascular prostheses are not addressed in this International Standard.

NOTE Requirements for vascular device-drug combination products are specified in ISO 12417-1.

1.11 Degradation, tissue ingrowth and/or tissue replacement, and other time-dependent aspects of absorbable vascular prostheses are not addressed in the standard.

PDF Catalog

PDF Pages PDF Title
7 Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC [OJ L 169] on medical devices
12 Foreword
13 Introduction
14 1 Scope
15 2 Normative references
3 Terms and definitions
19 4 General requirements
4.1 Configuration designation for tubular vascular grafts
20 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
21 4.3.3 Nomenclature
4.4 Intended clinical use designation
22 5 Intended performance
6 Design attributes
6.1 General
6.2 Tubular vascular grafts
6.3 Vascular patches
23 6.4 Coatings
6.5 Drug coatings and drug-eluting coatings
7 Materials
8 Design evaluation
8.1 General
24 8.2 Sampling
8.3 Conditioning of test samples
8.4 Reporting
25 8.5 Biocompatibility
8.5.1 Residual chemicals
8.5.2 Biocompatibility
8.6 Biostability
26 8.7 Bench and analytical tests
8.7.1 General
8.7.2 Tubular vascular grafts
28 8.7.3 Vascular patches
29 9 Preclinical in vivo evaluation test methods for vascular prostheses
9.1 Preclinical in vivo evaluation
9.1.1 Purpose
30 9.1.2 Specific aims
9.1.3 Protocol considerations
9.1.4 Data acquisition
31 9.1.5 Test report and additional information
32 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
33 10.1.4 Data acquisition
36 10.1.5 Final report
37 10.2 Post market surveillance
11 Manufacturing
12 Sterility
38 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
39 13.6.2 Record label
13.6.3 General information and instructions for use
40 Annex A (informative) Test methods
67 Bibliography

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BS EN ISO 7198:2017
$198.66