Full Description

1.1The 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.

1.2This 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.

1.3This 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.

1.4This goal is achieved by creating a partitioned, secondary area of an implants package label or a separate label to present this information uniformly.

1.5The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. It is recognized through our task groups efforts that, 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 that would allow the primary goal of uniform implant label design across manufacturers were identified.

1.6It is not the intent of this guide to limit or dictate overall package labeling content.

1.7It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements).

1.8The use or application of multiple languages is not prevented by this guide; however, use of more than one language is discouraged on the implant selection sublabel (ISSL) defined in this guide. The language of choice is left to the manufacturer and should be dictated by the end user and regulatory requirements in the jurisdictions where the device is marketed. International symbols should also be considered to avoid the need for multiple ISSLs where possible.

1.9Use and implementation of this guide is optional and at the sole discretion of the implants manufacturer. It shall be implemented with the following considerations:

1.9.1The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated.

1.9.2If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from implementing a hybrid label that partially applies the principles and recommendations in this guide.

1.10The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.11This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.12This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.