The purpose of this standard is to recommend a universal label format (between manufacturers and various implants) for the content and relative location of information required for final implant selection within the overall packaging labeling of an implant.
This standard recommends packaging labeling for musculoskeletal-based implants that are individually processed and packaged for opening at the point of use, typically in the operating room.
This standard defines "high priority" label content and recommendations for the layout and location of information for correct implant identification by end users in the operating room environment.
This goal is achieved by creating a segmented, secondary area of an implant's package label, or a separate label to present this information uniformly. It is not the intent of this guide to limit or dictate general package labeling content.
The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated. If internal risk management activities suggest deviating from this guideline, the manufacturer is advised not to apply a hybrid label that partially implements the principles and recommendations in this guideline.
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
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