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BSI - PD ISO/TS 17137

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

active, Most Current
Organization: BSI
Publication Date: 30 September 2021
Status: active
Page Count: 46
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 F2606 - Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
Published by ASTM on October 1, 2008
This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing...
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:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
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