PD ISO/TS 17137:2014

1   Scope This Technical Specification outlines design verification and validation considerations for absorbable cardiovascular implants.

NOTE Due to the variations in the design of implants covered by this Technical Specification and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this Technical Specification will be necessary.

For the purpose of this Technical Specification the terms “vessel and/or vascular space” refer to the entire circulatory system, including the heart and all vasculature. This Technical Specification is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This technical specification 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 Technical Specification 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.