BS EN ISO 7198:2017 PDF

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

First page of standard BS EN ISO 7198:2017

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Title (English):

BS EN ISO 7198:2017

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

Format:: Electronic (PDF)
Publication date:: March 31, 2017
ICS:: 11.040.40
Technical committee:: CEN
SKU:: BS EN ISO 7198:2017

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Abstract

1 Scope

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.

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Mentioned in the description and other BS standards

1 Scope

BS EN ISO 7198:2017 PDF

Abstract

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Abstract

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