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
Price:
$ 31.00
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
Pages:
16 pages
Scope
This document specifies the technical requirements, marking, packaging, transportation, storage, and quality certification documents for polyetheretherketone (PEEK) powder and molding samples used in medical additive manufacturing, and describes the test methods.
This document is applicable to PEEK powder for powder bed fusion processes using laser as the energy source.
Development Information
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
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