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 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.Cross References:ISO 11135ISO 14971ISO 25539 (all parts)ISO 10993 (all parts)ISO 5840 (all parts)ISO 14937ASTM F640ISO 17665-1 ISO 11137 (all parts)ISO 14155ISO 14630ISO/TR 37137ISO 12417-1ISO 11607-1ISO/IEC Guide 51ANSI/AAMI HE74ASTM F2394ASTM F1980ISO 13781ASTM F3160ASTM F2213ISO/IEC 17025ASTM F2914ISO 15223-1ASTM F3268ISO 11607-2 ASTM F3320ASTM F2129ASTM F1635AAMI TIR17ASTM F2182 ASTM F2503ASTM F2119ISO/IEC Guide 63ASTM F3211ASTM F2743ASTM F3044ASTM F2052IEC 62366-1ASTM F2902ISO/TR 14283AAMI TIR42