GB 8662-1988
Replaced
YY/T 2008-2026
Pending
Industry standards-Medicine
YY/T 2008-2026 Medical additive manufacturing—Powders of polyether-ether-ketone for powder bed fusion
YY/T 2008-2026 Medical additive manufacturing—Powders of polyether-ether-ketone for powder bed fusion
Basic Information
Standard Code:
YY/T 2008-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2026-03-09
Implement Date:
2027-03-01
Publisher:
国家药品监督管理局
Technical Committee:
医用增材制造技术医疗器械标准化技术归口单位
Pages:
16 pages
Scope
本文件规定了用于医用增材制造的聚醚醚酮(PEEK)粉末料和成形试样性能的技术要求、标识、包装、运输、贮存及质量证明文件,描述了试验方法。
本文件适用于以激光作为能量源的粉末床熔融工艺的PEEK粉末。
Development Information
Drafting Units:
西安交通大学、国家药品监督管理局医疗器械技术审评检查大湾区分中心、中国食品药品检定研究院、天津市医疗器械质量监督检验中心、西安康拓医疗技术股份有限公司、深圳大学、吉林省中研高分子材料股份有限公司、浙江中聚生物科技有限公司、上海交通大学医学院附属第九人民医院、华南理工大学医疗器械研究检验中心
Drafting Persons:
孙畅宁、李涤尘、韩丹、韩倩倩、张述、毛歆、丁金聚、尚玮玮、倪卓、童艳玲、陈科进、赵峰、邓亮、王智杰、李冰
Referenced Standards
GB/T 1033.1-2008 Plastics—Methods for determining the density of non-cellular plastics—Part 1:Immersion method,liquid pyknometer method and titration method
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 1040.4-2006 Plastics—Determination of tensile properties—Part 4:Test conditions for isotropic and orthotropic fibre-reinforced plastic composites
GB/T 1040.5-2008 Plastics—Determination of tensile properties—Part 5:Test conditions for unidirectional fibre-reinforced plastic composites
GB/T 1041-2008 Plastics—Detemination of compressive properties
GB/T 1043-1993 Plastics—Determination of charpy impact strength of rigid materials
GB/T 1043.1-2008 Plastics—Determination of charpy impact properties—Part 1:Non-instrumented impact test
GB/T 1043.2-2018 Plastics—Determination of charpy impact properties—Part 2:Instrumented impact test
GB/T 1843-1996 Plastics—Determination of izod impact strength
GB/T 1843-2008 Plastics—Determination of izod impact strength
GB/T 2411-1980 Plastics—Shore hardness test
GB/T 2411-2008 Plastics and ebonite—Determination of indentation hardness by means of a durometer(shore hardness)
GB/T 3398.1-2008 Plastics—Determination of hardness—Part 1:Ball indentation method
GB/T 3398.2-2008 Plastics—Determination of hardness—Part 2:Rockwell hardness
GB/T 3682.1-2018 Plastics—Determination of the melt mass-flow rate(MFR)and melt volume-flow rate(MVR)of thermoplastics—Part 1:Standard method
GB/T 9341-2000 Plastics—Determination of flexural properties
GB/T 9341-2008 Plastics—Determination of flexural properties
GB/T 14234-1993 Surface roughness for plastic parts
GB/T 15337-1994 General rules for atomic absorption spectrometric analysis
GB/T 15337-2008 General rules for atomic absorption spectrometric analysis
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
GB/T 16913-2008 Methods of dust character test
GB/T 16913.1-1997 Methods of dust character test—Part 1:Dust sampling
GB/T 16913.2-1997 Methods of dust character test—Part 2:Determination of effective density—Pyknometer method
GB/T 16913.3-1997 Methods of dust character test—Part 3:Determination of bulk density—Natural bulk method
GB/T 16913.4-1997 Methods of dust character test—Part 4:Determination of dispersivity—Andreason pipette method
GB/T 16913.5-1997 Methods of dust character test—Part 5:Determination of reposeful angle—Poured angle of restrictive pile
GB/T 16913.6-1997 Methods of dust character test—Part 6:Determination of hygroscopy—Hygroscopicity method
GB/T 16913.7-1997 Methods of dust character test—Part 7:Determination of moisture content—Dry method
GB/T 16913.8-1997 Methods of dust character test—Part 8:Determination of immersion—Immersion speed method
GB/T 16913.9-1997 Methods of dust character test—Part 9:Determination of cohesion—Normal pull rift method
GB/T 16913.10-1997 Methods of dust character test—Part 10:Determination of electrical resistivity—Disk method
GB/T 16913.11-1997 Methods of dust character test—Part 11:Determination of field resistivity—Concentric rings method by means of filtration
GB/T 19077-2016 Particle size analysis—Laser diffraction methods
GB/T 19077-2024 Particle size analysis—Laser diffraction methods
GB/T 19077.1-2003 Particle size analysis—Laser diffraction method
GB/T 19077.1-2008 Particle size analysis—Laser diffraction methods—Part 1:General principles
GB/T 21354-2008 Powders—Determination of tap density
GB/T 25278-2010 Plastics—Determination of the fluidity of plastics using capillary and slit-die rheometers
GB/T 33047.1-2016 Plastics—Thermogravimetry(TG)of polymers—Part 1:General principles
GB/T 33047.1-2025 Plastics—Thermogravimetry(TG) of polymers—Part 1:General principles
GB/T 33047.2-2021 Plastics—Thermogravimetry (TG) of polymers—Part 2:Determination of activation energy
GB/T 33047.3-2021 Plastics—Thermogravimetry (TG) of polymers—Part 3:Determination of the activation energy using the Ozawa-Friedman plot and analysis of the reaction kinetics
GB/T 35351-2025 Additive manufacturing—Terminology
GB/T 37463-2019 Additive manufacturing—Specification for powder bed fusion of plastic materials
GB/T 39486-2020 Chemical reagent—General rules for inductively coupled plasma mass spectrometry
JY/T 0568-2020 The general method for inductively coupled plasma mass spectrometry analysis
YY/T 0033-2000 Good manufacture practice for sterile medical devices
YY/T 0033-1990 Sterile medical device production management specifications
YY 0033-2000 Sterile medical device production management regulations
YY/T 0618-2007 Bacterial endotoxins—Test methodologies,routine monitoring,and alternatives to batch testing
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices—Routine monitoring and alternatives to batch testing
YY/T 0660-2008 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications
YY/T 1707-2020 Implants for surgery—Differential scanning calorimetry of poly ether ether ketone (PEEK)polymers and compounds for use in implantable medical devices
中华人民共和国药典(2025版)四部
Related Standards
GB 2766-1995
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GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced