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NEN - NPR-ISO/TS 17137

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

active, Most Current
Organization: NEN
Publication Date: 1 September 2019
Status: active
Page Count: 40
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

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.

NOTE 1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1.

NOTE 2 An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A of this document.

Document History

NPR-ISO/TS 17137
September 1, 2019
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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...
June 1, 2014
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
NPR-ISO/TS 17137 outlines design verification and validation considerations for absorbable cardiovascular implants. For the purpose of this Technical Specification the terms “vessel and/or vascular...

References

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