ISO/TS 17137:2014 outlines design verification and validation considerations for absorbable cardiovascular implants.
ISO/TS 17137:2014 is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. ISO/TS 17137:2014 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 ISO/TS 17137:2014 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.
Текущий статус : WithdrawnДата публикации : 2014-05
Версия : 1Число страниц : 26
Технический комитет:Cardiovascular implants and extracorporeal systems