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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 02-08-2016
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representationBackground of AAMI adoption of ISO 7198:2016ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Intended performance6 Design attributes7 Materials8 Design evaluation9 Preclinical in vivo evaluation test methods for vascular prostheses10 Clinical investigation methods for vascular Prostheses11 Manufacturing12 Sterility13 Packaging and labelingAnnex A (informative) - Test methodsBibliography
Describes 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.
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