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 11135
ISO 14971
ISO 25539 (all parts)
ISO 10993 (all parts)
ISO 5840 (all parts)
ISO 14937
ASTM F640
ISO 17665-1
ISO 11137 (all parts)
ISO 14155
ISO 14630
ISO/TR 37137
ISO 12417-1
ISO 11607-1
ISO/IEC Guide 51
ANSI/AAMI HE74
ASTM F2394
ASTM F1980
ISO 13781
ASTM F3160
ASTM F2213
ISO/IEC 17025
ASTM F2914
ISO 15223-1
ASTM F3268
ISO 11607-2
ASTM F3320
ASTM F2129
ASTM F1635
AAMI TIR17
ASTM F2182
ASTM F2503
ASTM F2119
ISO/IEC Guide 63
ASTM F3211
ASTM F2743
ASTM F3044
ASTM F2052
IEC 62366-1
ASTM F2902
ISO/TR 14283
AAMI TIR42


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