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BSI - BS EN ISO 16061 - TC

Tracked Changes (Redline) - Instrumentation for use in association with non-active surgical implants - General requirements

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Organization: BSI
Publication Date: 25 February 2020
Status: inactive
Page Count: 66
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 - TC
November 9, 2021
Tracked Changes (Redline) - Instrumentation for use in association with non-active surgical implants - General requirements
A description is not available for this item.
BS EN ISO 16061 - TC
February 25, 2020
Tracked Changes (Redline) - Instrumentation for use in association with non-active surgical implants - General requirements
A description is not available for this item.

References

This document references:
ISO 5832-4 - Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
Published by ISO on September 15, 2014
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, cobaltchromium- molybdenum casting alloy for use in the manufacture of surgical implants. NOTE The...
This document references:
ISO 7151 - Surgical Instruments - Non-Cutting, Articulated Instruments - General Requirements and Test Methods Second Edition
Published by ISO on January 1, 1988
A description is not available for this item.
This document references:
ISO 7740 - Instruments for Surgery - Scalpels with Detachable Blades - Fitting Dimensions
Published by ISO on January 1, 1985
A description is not available for this item.
This document references:
ISO 11140-5 - Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dicktype air removal tests
Published by ISO on March 15, 2007
A description is not available for this item.
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document references:
ISO 7740 - Instruments for Surgery - Scalpels with Detachable Blades - Fitting Dimensions
Published by ISO on January 1, 1985
A description is not available for this item.
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