GSO ASTM F2943:2021
ASTM F2943:14
Gulf Standard
Current Edition
·
Approved on
01 July 2021
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
GSO ASTM F2943:2021 Files
English
8 Pages
Current Edition
Reference Language
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GSO ASTM F2943:2021 Scope
1.1 The goal of this guide is to recommend a universal label
format (across manufacturers and various implants) of content
and relative location of information necessary for final implant
selection within an implant’s overall package labeling.
1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged
with the intent of being opened at the point of use, typically in
the operating room.
1.3 This guide identifies the necessary, “high priority” label
content and recommendations for the layout and location of
information for accurate implant identification by the end users
in the operating room environment.
1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to
present this information uniformly.
1.5 The authors of this guide identified the competing needs
of regulatory requirements, manufacturing/distribution, and
implant identification. It is recognized through our task group’s
efforts that, if a manufacturer elects to implement these
recommendations, balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory (either at a single point in time or
over a defined time period), or accepting duplicate information
on an implant’s package label. No additional compromises that
would allow the primary goal of uniform implant label design
across manufacturers were identified.
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