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BSI - BS ISO 22679

Cardiovascular implants — Transcatheter cardiac occluders

active, Most Current
Organization: BSI
Publication Date: 31 December 2021
Status: active
Page Count: 82
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS ISO 22679
December 31, 2021
Cardiovascular implants — Transcatheter cardiac occluders
A description is not available for this item.

References

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 E2789 - Standard Guide for Fretting Fatigue Testing
Published by ASTM on November 1, 2010
This guide defines terminology and covers general requirements for conducting fretting fatigue tests and reporting the results. It describes the general types of fretting fatigue tests and provides...
This document references:
ASTM F3172 - Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
Published by ASTM on December 15, 2015
This guide provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular...
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...
This document references:
IEC TR 62366-2 - Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
Published by IEC on April 1, 2016
This Part of IEC 62366, which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing...
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