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ISO - 9713

Neurosurgical implants — Self-closing intracranial aneurysm clips

active, Most Current
Organization: ISO
Publication Date: 1 January 2022
Status: active
Page Count: 16
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.

This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).

NOTE In this document when not otherwise established, the term "implant" refers to the self-closing intracranial aneurysm clips.

Document History

9713
January 1, 2022
Neurosurgical implants — Self-closing intracranial aneurysm clips
This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization...
ISO 9713
September 1, 2002
Neurosurgical Implants - Self-Closing Intracranial Aneurysm Clips
A description is not available for this item.
9713
January 1, 1990
Neurosurgical Implants - Self-Closing Intracranial Aneurysm Clips First Edition
A description is not available for this item.

References

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...
This document references:
ASTM F2182 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Published by ASTM on September 15, 2019
This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not...
This document references:
ASTM F2213 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Published by ASTM on September 1, 2017
This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that...
This document references:
ASTM F2503 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Published by ASTM on February 1, 2020
This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be...
This document is referenced by:
BS ISO 16142-1 - TC - Tracked Changes (Redline) - Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by BSI on February 24, 2020
A description is not available for this item.
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