Over deze norm
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 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 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.
1.7 The use or application of multiple languages is not prevented by this guide; however, 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 ISSL where possible.
|Engelse titel||Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty|