PD ISO/TS 17137:2019 - Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants

PD ISO/TS 17137:2019

Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants

Status : Current   Published : September 2019

Format
PDF

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HARDCOPY



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.




Standard NumberPD ISO/TS 17137:2019
TitleCardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
StatusCurrent
Publication Date10 September 2019
Normative References(Required to achieve compliance to this standard)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
Informative References(Provided for Information)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
ReplacesPD ISO/TS 17137:2014
International RelationshipsISO/TS 17137:2019
DescriptorsVerification, Testing, Circulatory system, Analysis, Implants (surgical), Degradation, Packaging, Design
ICS11.040.40
Title in FrenchImplants cardiovasculaires et systèmes extracorporels. Implants cardiovasculaires absorbables
CommitteeCH/150/2
ISBN978 0 539 02806 5
PublisherBSI
FormatA4
DeliveryYes
Pages38
File Size1.692 MB
Price£214.00


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