ASTM WK27458

1. 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 implants overall package labeling (applying a similar philosophy found with uniform labeling in other industries, such as with food nutrition labels, standard international logistics shipping labels, and fertilizer labeling). 1.2 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. 1.3 This goal is achieved by creating a partitioned, secondary area of an implants package label or a separate 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, relabeling their entire inventory (either at a single point in time or over a defined time period), or accepting duplicate information on an implants package label. No additional compromises were identified 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 This is an English language centric guide. The use or application of other languages to other areas of the product label are not prevented by this guide; they are discouraged from the portioned, secondary area of the implants label. Implementation of this guides recommendations, using languages other than English, in a separate, additional sublabel located on a different surface than the ISSL is possible. 1.8 Use and implementation of this guide is optional and at the sole discretion of the implants manufacturer and shall be implemented with the following considerations: 1.8.1 The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated and 1.8.2 If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from implementing a hybrid label, which partially applies the principles and recommendations of information organization from this standard. 1.9 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.11 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

[Back to Top]