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BSI - BS EN ISO 7197

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components

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Organization: BSI
Publication Date: 31 October 2009
Status: active
Page Count: 16
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

23/30444629 DC
June 19, 2023
Draft BS EN ISO 7197 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
A description is not available for this item.
BS EN ISO 7197
October 31, 2009
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
A description is not available for this item.
BS EN ISO 7197
December 31, 2008
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
A description is not available for this item.
BS ISO 7197
February 15, 1998
Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components
A description is not available for this item.

References

This document references:
93/42/EEC - Council Directive Concerning Medical Devices
Published by EU on June 14, 1993
Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both...
This document references:
ASTM F2038 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
Published by ASTM on December 1, 2018
This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids,...
This document references:
ASTM F2042 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
Published by ASTM on December 1, 2018
This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders,...
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 references:
ASTM F640 - Standard Test Methods for Determining Radiopacity for Medical Use
Published by ASTM on October 1, 2020
These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual...
This document references:
ASTM F640 - Standard Test Methods for Determining Radiopacity for Medical Use
Published by ASTM on October 1, 2020
These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual...
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
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