Norm

ISO/TS 17137:2019 en

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

115,50 139,75 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 29
Commissie Chirurgische implantaten
Gepubliceerd op 01-09-2019
Taal Engels
ISO/TS 17137 outlines design evaluation guidelines for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is meant to supplement device-specific standards by providing guidelines specific for absorbable implants and/or components This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of This document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant.

Details

ICS-code 11.040.40
Engelse titel Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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