PD ISO/TS 17137:2019

This document 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.

1 This document 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 componentsThis 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. NOTE1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1 . NOTE2 An explanation of the nomenclature of absorb, degrade and related terms can be found in AnnexA of this document.