This standard specifies the definition, requirements, test methods, inspection rules, instructions for use, markings, packaging, transportation, storage and usage requirements of non-active surgical implants for bone jointing. This standard applies to non-active surgical implants for bone jointing made of metal materials (referred to as "bone jointing implants"). This standard does not apply to bone grafting implants with surface coating or surface treatment.
YY 0341-2002 history
2020YY 0341.2-2020 Passive Surgical Implants Osteosynthesis and Spinal Implants Part 2: Special Requirements for Spinal Implants
2009YY 0341-2009 General technological requirements for non-active metallic surgical implants for osteosynthesis
2002YY 0341-2002 General technological requirements for non-active metallic surgery implants of osteosynthesis