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BSI - BS PD ISO/TS 17137

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

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Organization: BSI
Publication Date: 30 September 2019
Status: active
Page Count: 38
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

PD ISO/TS 17137
September 30, 2021
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
A description is not available for this item.
BS PD ISO/TS 17137
September 30, 2019
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
A description is not available for this item.
BS PD ISO/TS 17137
June 30, 2014
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
A description is not available for this item.

References

This document references:
TIR17 - Compatibility of materials subject to sterilization
Published by AAMI on January 1, 2017
This document provides guidance for health care product manufacturers in the selection and qualification of polymeric materials, ceramics, and metals for use in health care products sterilized by the...
This document references:
AAMI TIR42 - Evaluation of particulate associated with vascular medical devices
Published by AAMI on January 1, 2021
General This document addresses particulate released from intravascular medical devices that have direct contact with circulating blood. It is intended to assist intravascular medical device...
This document references:
ASTM F2743 - Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Published by ASTM on October 1, 2011
This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent...
This document references:
F2914 - Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
January 15, 2012
This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug...
This document references:
ASTM F3044 - Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
Published by ASTM on August 15, 2020
This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as...
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