BS 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. 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

All current amendments available at time of purchase are included with the purchase of this document.