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BSI - BS PD ISO/TS 17137 - TC

Tracked Changes (Redline) - Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

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Organization: BSI
Publication Date: 24 February 2020
Status: active
Page Count: 83
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

PD ISO/TS 17137 - TC
October 1, 2021
Tracked Changes (Redline) - Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
A description is not available for this item.
BS PD ISO/TS 17137 - TC
February 24, 2020
Tracked Changes (Redline) - Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
A description is not available for this item.

References

This document references:
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
This document references:
ASTM F1635 - Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Published by ASTM on December 1, 2016
This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants. The requirements of this test method apply to HDPs in various forms:...
This document references:
ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Published by ASTM on September 15, 2016
This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system...
This document references:
F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
October 1, 2021
This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of...
This document references:
ASTM F2119 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Published by ASTM on September 1, 2007
This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or...
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