GB 12264-1990
Replaced
YY/T 0474-2025
Pending
Industry standards-Medicine
YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing
YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing
Basic Information
Standard Code:
YY/T 0474-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2025-09-15
Implement Date:
2026-10-01
Publisher:
国家药品监督管理局
Technical Committee:
全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Pages:
24 pages
Scope
本文件描述了聚丙交酯(以L-丙交酯、D-丙交酯和/或D,L-丙交酯为结构单元的均聚物、共聚物和/或共混物)在体外降解条件下化学和/或机械性能变化的测定方法。本文件还描述了可吸收聚丙交酯或其他可水解材料及器械进行体外降解表征所需的基本物理和机械性能评价。
本文件适用于生产外科植入物的聚丙交酯均聚物、共聚物和/或共混物,包括原材料、加工材及最终产品(经包装和灭菌的植入物)。
本文件中规定的试验方法,也用于测定含有其他共聚单体(如乙交酯、三亚甲基碳酸酯和/或ε-己内酯)的聚丙交酯基的共聚物和/或共混物的体外降解速率和相关材料特性的变化。本文件中的体外试验方法不能用来准确预测材料在体内的行为,除非对具体器械进行了验证。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、天津市医疗器械质量监督检验中心、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、大博医疗科技股份有限公司、国家骨科与运动康复临床医学研究中心(中国人民解放军总医院)
Drafting Persons:
杜福映、李秋迎、李沅、黄永富、曾达、刘婉姮、朱进清、张花美、李建涛、吴晓丽、彭海韵
Replace the following standards
Referenced Standards
GB/T 1040.1-2006 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.1-2018 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.1-2025 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.2-2022 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
GB/T 1041-2008 Plastics—Detemination of compressive properties
GB/T 1632.1-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles
GB/T 1632.1-2024 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles
GB/T 1843-1996 Plastics—Determination of izod impact strength
GB/T 1843-2008 Plastics—Determination of izod impact strength
GB/T 3916-1997 Textiles—Yarns from packages—Determination of single-end breaking force and elongation at break
GB/T 3916-2013 Textiles—Yarns from packages—Determination of single-end breaking force and elongation at break using constant rate of extension(CRE) tester
GB/T 3923.1-1997 Textiles—Tensile properties of fabrics—Part 1:Determination of breaking force and elongation at breaking force—Strip method
GB/T 3923.1-2013 Textiles—Tensile properties of fabrics—Part 1:Determination of maximum force and elongation at maximum force using the strip method
GB/T 9341-2000 Plastics—Determination of flexural properties
GB/T 9341-2008 Plastics—Determination of flexural properties
GB/T 21864-2008 Standard test method for molecular weight averages and molecular weight distribution of polystyrene—High performance size-exclusion chromatography
GB/T 33061.2-2025 Plastics—Determination of dynamic mechanical properties—Part 2:Torsion-pendulum method
GB/T 36214.1-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 1:General principles
GB/T 36214.2-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 2:Universal calibration method
GB/T 36214.3-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 3:Low-temperature method
GB/T 36214.4-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 4:High-temperature method
GB/T 36214.5-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 5:Method using light-scattering detection
GB/T 36214.2-2018 Plastics—Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography—Part 2:Universal calibration method
JC/T 773-2010 Fiber-reinforced plastic interlayer shear strength determined by short beam method
SC/T 4022-2007 The determination of breaking strength and knot breaking strength of fishing nets
Adopt standards
ISO 13781:2017
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