GB 12264-1990
Replaced
YY 0341-2002
Replaced
Industry standards-Medicine
YY 0341-2002 General technological requirements for non-active metallic surgery implants of osteosynthesis
YY 0341-2002 General technological requirements for non-active metallic surgery implants of osteosynthesis
Basic Information
Standard Code:
YY 0341-2002
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2002-09-24
Implement Date:
2003-04-01
Pages:
12 pages
Scope
This standard specifies the definitions, requirements, test methods, inspection rules, user manuals, markings, packaging, transportation and storage, and usage requirements for non-active surgical implants used in bone fixation.
This standard applies to non-active surgical implants for bone fixation made of metal materials (referred to as "bone fixation implants").
This standard does not apply to bone fixation implants with surface coatings or subjected to surface treatments.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 228-2002 Metallic materials—Tensile testing at ambient temperature
GB/T 228.1-2010 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 228.1-2021 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 228.2-2015 Metallic materials—Tensile testing—Part 2:Method of test at elevated temperature
GB/T 228.3-2019 Metallic materials—Tensile testing—Part 3:Method of test at low temperature
GB/T 228.4-2019 Metallic materials—Tensile testing—Part 4:Method of test in liquid helium
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.2-1999 Metallic vickers hardness test—Part 2:Verification of hardness testers
GB/T 4340.2-2012 Metallic materials—Vickers hardness test—Part 2:Verification and calibration of testing machines
GB/T 4340.3-1999 Metallic vickers hardness test—Part 3:Calibration of hardness reference blocks
GB/T 4340.3-2012 Metallic materials—Vickers hardness test—Part 3:Calibration of reference blocks
GB/T 4340.4-2009 Metallic materials—Vickers hardness test—Part 4:Tables of hardness values
GB/T 4340.4-2022 Metallic materials—Vickers hardness test—Part 4:Tables of hardness values
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 15239-1994 Sampling procedures and tables for isolated lot inspection by attributes
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0340-2002 Implants for surgery—Fundamental principles
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products
YY/T 0340-2009 YY/T 0340-2009 Surgical Implants Basic Principles
GB/T 4340.2-2025 Metallic materials—Vickers hardness test—Part 2:Verification and calibration of testing machines
GB/T 4340.3-2025 Metallic materials—Vickers hardness test—Part 3:Calibration of reference blocks
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 2829-2025 Sampling procedures and tables for periodic inspection by attributes(Apply to inspection of process stability)
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced