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ISO 16061 FRENCH

Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales

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Organization: ISO
Publication Date: 1 December 2008
Status: inactive
Page Count: 24
ICS Code (Other medical equipment): 11.040.99
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

ISO 16061 FRENCH
March 1, 2021
Instruments à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
A description is not available for this item.
ISO 16061 FRENCH
May 15, 2015
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales
A description is not available for this item.
ISO 16061 FRENCH
December 1, 2008
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales
A description is not available for this item.

References

This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
EN 556-1 - Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
Published by CEN on October 1, 2001
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of this European Standard specifies the requirements for an aseptically...
This document references:
EN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Published by CEN on September 1, 2015
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see...
This document references:
IEC 60068-2-27 - Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock
Published by IEC on February 1, 2008
Object To provide a standard procedure for determining the ability of a specimen to withstand specified severities of shock.
This document references:
IEC 60068-2-31 - Environmental testing – Part 2-31: Tests – Test Ec: Rough handling shocks, primarily for equipment-type specimens
Published by IEC on May 1, 2008
This part of IEC 60068 deals with a test procedure for simulating the effects of rough handling shocks, primarily in equipment-type specimens, the effects of knocks, jolts and falls which may be...
This document is referenced by:
BS EN ISO 9713 - Neurosurgical implants - Self-closing intracranial aneurysm clips
Published by BSI on October 31, 2009
A description is not available for this item.
This document is referenced by:
ISO 5840-1 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
Published by ISO on January 1, 2021
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This...
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