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BSI - BS EN ISO 16061

Instruments for use in association with non-active surgical implants — General requirements

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Organization: BSI
Publication Date: 30 April 2021
Status: active
Page Count: 24
ICS Code (Other medical equipment): 11.040.99
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN ISO 16061
April 30, 2021
Instruments for use in association with non-active surgical implants — General requirements
A description is not available for this item.
BS EN ISO 16061
May 31, 2015
Instrumentation for use in association with non-active surgical implants - General requirements
A description is not available for this item.
BS EN ISO 16061
December 31, 2009
Instrumentation for use in association with non-active surgical implants - General requirements
A description is not available for this item.
BS EN ISO 16061
May 31, 2009
Instrumentation for use in association with non-active surgical implants - General requirements
A description is not available for this item.

References

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 references:
IEC 60068-2-47 - Environmental testing – Part 2-47: Tests – Mounting of specimens for vibration, impact and similar dynamic tests
Published by IEC on April 1, 2005
This part of IEC 60068 provides methods for mounting products, whether packaged or unpackaged, as well as mounting requirements for equipment and other articles, for the series of dynamic tests in...
This document references:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
IEC 62570 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Published by IEC on February 1, 2014
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 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:
BS EN ISO 13504 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
Published by BSI on July 31, 2012
A description is not available for this item.
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