YY/T 2008-2026Medical additive manufacturing - Powders of polyether-ether-ketone for powder bed fusion (English PDF)

1 Scope

This document specifies the technical requirements, labeling, and packaging for the properties of polyetheretherketone (PEEK) powder and molded specimens used in medical additive manufacturing.

The packaging, transportation, storage, and quality certification documents describe the test methods.

This document applies to PEEK powders produced using a powder bed melting process with laser as the energy source.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

document.

GB/T 1033.1 Determination of density of non-foamed plastics – Part 1.Impregnation method, liquid pyrometer method and titration method

GB/T 1040 (all parts) Determination of tensile properties of plastics

GB/T 1041 Determination of compressive properties of plastics

GB/T 1043 (all parts) Determination of impact properties of simply supported plastic beams

GB/T 1843 Determination of impact strength of plastic cantilever beams

GB/T 2411 Plastics and hard rubber - Determination of indentation hardness (Shore hardness) using a hardness tester

GB/T 3398.1 Determination of hardness of plastics - Part 1.Ball indentation method

GB/T 3398.2 Determination of hardness of plastics - Part 2.Rockwell hardness

GB/T 3682.1 Determination of melt mass flow rate (MFR) and melt volumetric flow rate (MVR) of thermoplastics

Part 1.Standard Methods

GB/T 9341 Determination of Flexural Properties of Plastics

GB/T 14234 Surface roughness of plastic parts

GB/T 15337 General Rules for Atomic Absorption Spectrometry

GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process

GB/T 16913 Test methods for physical properties of dust

GB/T 19077 Laser diffraction method for particle size distribution

GB/T 21354 General Method for Determination of Tap Density of Powder Products

GB/T 25278 Determination of the flowability of plastics using a capillary and slit-die rheometer

GB/T 33047 (all parts) Thermogravimetric analysis (TG) of plastic polymers

GB/T 35351-2025 Additive Manufacturing Terminology

GB/T 37463 Specification for Powder Bed Melting Process of Additive Manufacturing Plastic Materials

GB/T 39486 General Rules for Inductively Coupled Plasma Mass Spectrometry Analysis of Chemical Reagents

JY/T 0568 General Rules for Inductively Coupled Plasma Mass Spectrometry

YY/T 0033 Standard for Production Management of Sterile Medical Devices

YY/T 0618 Routine monitoring and skip-batch inspection of bacterial endotoxin test methods for medical devices

YY/T 0660 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implants […]