1. Scope
1.1 The goal of this guide is to recommend a universal format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implants overall package labeling (similar in nature to the Food and Drug Administrations [FDA] food nutrition label). 1.2 This guide identifies the necessary, high-priority label content and recommendations for the layout and location of this high-priority information necessary for accurate implant identification by healthcare professionals (the end user) in the operating room environment. 1.3 This goal is achieved by creating a partitioned, secondary area of an implants package label to present this information uniformly. 1.4 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. Through our task groups efforts it is recognized, if a manufacturer elects to implement these recommendations, balancing these competing needs may necessitate changing a manufacturers internal processes or duplicate information on an implants package label. No additional compromises were available that still allow the primary goal of uniform implant label design across manufacturers. 1.5 It is not the intent of this guide to limit or dictate overall package labeling content. 1.6 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements). 1.7 Use and implementation of this guide is optional and at the sole discretion of the implant manufacturer. 1.8 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Current implant labels present information in a nonstandard format that results in misreading of information.
Keywords
implant; label; end of the box; end user; size
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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