GSO ASTM F2943:2021

ASTM F2943:14
Gulf Standard   Current Edition · Approved on 01 July 2021

Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

GSO ASTM F2943:2021 Files

English 8 Pages
Current Edition Reference Language

GSO ASTM F2943:2021 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 implant’s overall package labeling. 1.2 This 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. 1.3 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 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to present this information uniformly. 1.5 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.

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
YSMO GSO 2017:2023
GSO 2017:2023 
Yemeni Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 1223:2023
 
Gulf Standard
Cosmetic Products-Deodorants

Recently Published from Health Sector

GSO ISO 21103:2026
ISO 21103:2014 
Gulf Standard
Adventure tourism — Information for participants
GSO ASTM F1917:2026
ASTM F1917:23 
Gulf Standard
Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories
GSO ISO 11956:2026
ISO 11956:2025 
Gulf Standard
Adventure tourism — Cyclotourism — Requirements and recommendations
GSO ISO 16520:2026
ISO 16520:2025 
Gulf Standard
Tourism and related services — Restaurants and catering — Vocabulary