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BSI - BS ISO 7197

Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components

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Organization: BSI
Publication Date: 15 February 1998
Status: inactive
Page Count: 20
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:
BS EN ISO 11138-3 - Sterilization of health care products - Biological indicators Part 3: Biological indicators for moist heat sterilization processes
Published by BSI on April 30, 2017
A description is not available for this item.
This document references:
BS EN ISO 11137-2 - Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose
Published by BSI on June 30, 2015
A description is not available for this item.
This document references:
BS EN ISO 10993-1 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published by BSI on December 31, 2020
A description is not available for this item.
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:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document references:
BS EN ISO 11137-3 - Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
Published by BSI on August 31, 2017
A description is not available for this item.
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
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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