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YY/T 1702-2020 English PDF (YYT1702-2020)

YY/T 1702-2020 English PDF (YYT1702-2020)

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YY/T 1702-2020: Dentistry--Additive manufacturing--Selective laser melting metallic materials for fixed and removable restorations and appliances

This Standard classifies and specifies the performance requirements and test methods of additive manufacturing metal materials for dental fixation and removable restoration, including those used for porcelain or not for porcelain, or both. It also stipulates the requirements for the package accompanying documents, instructions manual, marking and labeling of the product. This Standard is applicable to cobalt-chromium alloy, pure titanium and titanium alloy metal powders for selective laser melting of additive manufacturing processes.
YY/T 1702-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.060.10
C 33
Dentistry - Additive Manufacturing - Selective Laser
Melting Metallic Materials for Fixed and Removable
Restorations and Appliances
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JANUARY 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Classification ... 8
5 Requirements ... 9
6 sampling ... 12
7 Preparation of Sample ... 12
8 Test Method ... 15
9 Information and Instruction Manual ... 20
10 Marking and Label ... 22
Bibliography ... 23
Dentistry - Additive Manufacturing - Selective Laser
Melting Metallic Materials for Fixed and Removable
Restorations and Appliances
1 Scope
This Standard classifies and specifies the performance requirements and test methods of additive manufacturing metal materials for dental fixation and removable restoration, including those used for porcelain or not for porcelain, or both. It also stipulates the requirements for the package accompanying documents, instructions manual, marking and labeling of the product.
This Standard is applicable to cobalt-chromium alloy, pure titanium and titanium alloy metal powders for selective laser melting of additive manufacturing processes. 2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 1479.1-2011 Metallic Powders - Determination of Apparent Density - Part 1: Funnel Method
GB/T 1482-2010 Metallic Powders - Determination of Flow Time by Means of a Calibrated Funnel (Hall Flowmeter)
GB/T 3851-2015 Hard Metals - Determination of Transverse Rupture Strength GB/T 4340.1-2009 Metallic Materials - Vickers Hardness Test - Part 1: Test Method GB/T 5162-2006 Metallic Powders - Determination of Tap Density
GB/T 5314-2011 Powders for Powder Metallurgical Purposes ?€? Sampling
GB/T 10610-2009 Geometrical Product Specifications(GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture GB/T 13298-2015 Inspection Methods of Microstructure for Metals
NOTE 2: Except as specified by the equipment manufacturer, the positive direction of x-axis is the direction from left to right when viewing from the front side of the equipment and facing the origin of the forming space.
NOTE 3: Usually the x-axis is in the horizontal position.
[GB/T 35351-2017, definition 2.3.20]
3.4 y-axis
The axis that is perpendicular to the x-axis and z-axis in the coordinate system of the equipment.
NOTE 1: Unless otherwise specified by the equipment manufacturer, it usually refers to the y- axis of the equipment.
NOTE 2: Except as specified by the equipment manufacturer, the definition of positive direction of the y-axis follows the right-hand rule of the coordinate system in GB/T 19660. Usually, when the z-axis is positively upwards, at this time, when viewing from the front side of the equipment, the direction from the front to the back of the equipment is the positive direction of the y-axis. When the z-axis is positively downwards, at this time, when viewing from the front side of the equipment, the direction from the back to the front of the equipment is the positive direction of the y-axis.
NOTE 3: Usually the y-axis is in the horizontal position.
[GB/T 35351-2017, definition 2.3.21]
3.5 z-axis
The coordinate axis that is perpendicular to the x-axis and y-axis (the plane formed by them) in coordinate system of the equipment.
NOTE 1: Unless otherwise specified by the equipment manufacturer, it usually refers to the z- axis of the equipment.
NOTE 2: Except as specified by the equipment manufacturer, the definition of the positive direction of z-axis follows the right-hand rule of the coordinate system in GB/T 19660. For a process that uses planes and materials to superimpose layer by layer, the normal direction of the layer is the positive direction of the z-axis. For the process that uses planes and materials to superimpose layer by layer, the positive direction of z-axis points from the first layer to the subsequent layer.
NOTE 3: When materials are superimposed from different directions [e.g.: in a directional energy deposition system], the z-axis may be determined according to rotation or rolling in GB/T 19660.
snap rings.
5 Requirements
5.1 Metal powder
5.1.1 Chemical composition
Test according to 8.1.1, it shall comply with the provisions of 5.1 in ISO 22674-2016. 5.1.2 Hazardous ingredients
Test according to 8.1.1, it shall comply with the provisions of 5.2 in ISO 22674-2016. 5.1.3 Powder appearance
Test according to 8.1.2, the powder is even, and there are no visible impurities. 5.1.4 Roundness
Test according to 8.1.3, the roundness shall be no less than the claimed value of the manufacturer.
5.1.5 Powder size and distribution
Test according to 8.1.4, D10???12??m; D90???65??m.
5.1.6 Powder flowability
Test according to 8.1.5, cobalt-chromium alloy powder: no more than 40s/50g; titanium and titanium-alloy powder: no more than 50s/50g.
5.1.7 Bulk density of powder
Test according to 8.1.6, cobalt-chromium alloy powder: no less than 4.0g/cm3; titanium and titanium alloy powder: no less than 2.2g/cm3.
5.1.8 Tap density of powder
Test according to 8.1.7, cobalt-chromium alloy powder: no less than 4.5g/cm3; titanium and titanium alloy powder: no less than 2.5g/cm3.
5.1.9 Solidus and liquidus temperature (alloy) or melting point (commercial pure metal)
Test according to 8.1.8, it shall meet the requirements of 5.9 in ISO 22674-2016. 5.1.10 Package accompanying documents, instructions manual, marking and See introduction.
6 sampling
The powder sampling by the manufacturer shall comply with GB/T 5314-2011. The sample amount shall be able to meet the requirements of 7.3 preparation of samples; and the taken samples should be of the same batch. In addition, packaging information, instructions manual, markings and labels shall meet the requirements of Clauses 9 and 10.
7 Preparation of Sample
7.1 Overview
Prepare all samples in accordance with the documents attached to the product package (see 9.1) and the manufacturer?€?s instruction manual (see 9.2).
The effect of printing direction on performance shall be fully considered. For the tensile performance, bending performance, corrosion resistance, anti-tarnish performance, linear expansion coefficient and metal-porcelain system performance, two sets of samples shall be prepared; that is, the long axis of the sample is parallel to the printing growth direction (z-axis direction) and the long axis of the sample is perpendicular to the printing growth direction (x-axis or y-axis direction). The performances of the two sets of specimens in the two printing directions shall both meet the requirements of the corresponding clauses.
Replace all samples with visible defects.
The sample preparer shall provide relevant information and main printing parameters (including at least: laser power, scanning speed, printing distance, spot diameter, and powder layer thickness) of the used printing equipment.
The relevant information and main printing parameters of the printing equipment provided by the manufacturer shall be confirmed; and the printed product performance shall meet all the requirements of this Standard. If the printing equipment and main printing parameters are changed, the printed product performance shall be reconfirmed according to 5.2.
7.2 Heat treatment
7.2.1 Metal materials recommended for heat treatment in the manufacturer?€?s instruction manual
If the manufacturer recommends heat treatment [9.2c)], the heat treatment shall be carried out in accordance with the heat treatment conditions specified in the manufacturer?€?s instruction manual, including for stress relief heat treatment and softening and hardening heat treatment, etc.
7.2.2 Metal materials for metal-porcelain restorations
It shall be carried out according to the provisions of 7.2.3 in ISO 22674-2016. 7.3 Specimen
The number of samples in this part does not include the metal materials that are used for metal-porcelain restorations. If the product is used for metal-porcelain restorations, the number of samples shall be doubled, and sample processing shall be carried out according to 7.2.2.
7.3.1 Surface roughness, hardness, density, inclusions and porosity
Prepare a cube sample with a side length of at least 10mm (e.g. 10mm??10mm??10mm) according to the manufacturer?€?s instruction manual; mark and print the positive direction of z-axis on the surface of the specimen (see 3.5); and perform heat treatment in accordance with 7.2.1; and prepare 6 specimens.
The above 4 tests share 1 set of specimens. The specimen shall maintain the original printed surface, and shall not be subjected to any metal processing such as grinding or turning, etc.
7.3.2 Dimension and warpage deformation
A single-sided cantilever beam specimen with a thickness of 1mm is used and prepared according to the size in Figure 1. The shape of the support is designed by the manufacturer and is consistent with the actual production process.
After printing is completed, perform heat treatment according to 7.2.1. Prepare 5 specimens.
Prepare the specimen with size of (25??2)mm ?? (2.0??0.1)mm ?? (2.0??0.1)mm according to the manufacturer?€?s instruction manual; respectively prepare 6 specimens with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and with the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Perform heat treatment on the specimen according to 7.2.1. 7.3.4 Corrosion resistance
Prepare sample in accordance with 7.7 in ISO 22674-2016. Respectively prepare 2 specimens with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Perform the heat treatment on the specimens according to 7.2.1.
7.3.5 Anti-tarnish
Prepare sample in accordance with 7.8 in ISO 22674-2016. Respectively prepare 2 specimens with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Perform the heat treatment on the specimens according to 7.2.1.
7.3.6 Linear thermal expansion
Prepare sample in accordance with 7.9 in ISO 22674-2016. Respectively prepare 2 specimens with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Perform the heat treatment on the specimens according to 7.2.1.
7.3.7 Performance of metal-porcelain system ?€? peel/crack initiation strength Prepare sample in accordance with the provisions of 6.4.2 in YY 0621.1-2016. Respectively prepare 6 specimens with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and with the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Perform heat treatment on the specimen according to 7.2.1.
8 Test Method
8.1 Metal powder
8.1.1 Chemical composition and hazardous ingredients
Test according to 8.2 in ISO 22674-2016, it shall comply with the provisions of 5.1.1 and 5.1.2.
provisions of 5.1.9.
8.1.9 Package accompanying documents, instruction manual, markings and
labels
Check whether it meets the requirements of Clauses 9 and 10.
8.2 Printout
In the test process of surface roughness, hardness, density, inclusions and porosity, in order to avoid the economic burden on the sample preparer due to repeated sample preparation, the same set of samples may be used for multi-item tests. The test sequence is to conduct surface roughness test first, and then to test hardness, density, inclusions and porosity.
8.2.1 Surface roughness
Prepare the sample according to 7.3.1; refer to the positive direction of z-axis marked on the surface of the specimen; and perform the test along the printing growth direction (z-axis). Test in accordance with the provisions of GB/T10610-2009; and measure the Ra value of the measured surface. All 6 specimens shall comply with the provisions of 5.2.1.
8.2.2 Dimensions
Measure by measuring instruments with an accuracy of at least 0.01mm.
Measure the thickness of the specimen prepared in accordance with 7.3.2; and the deviation of the thickness of the 5 specimens from the design dimensions shall meet the requirements of 5.2.2.
8.2.3 Warpage deformation
Prepare the sample according to 7.3.2; and perform heat treatment according to 7.2.1. Measure the height of the upper surface of the specimen at point A on the centerline (as shown in Figure 2, the farthest end of the cantilever beam), that is, the distance between point A on the upper surface of the specimen and the substrate. Pressure cannot be applied to the sample during the measurement. It is recommended to choose a non-contact measuring instrument, accurate to 0.01mm.
Then, truncate the 55mm support of the specimen, leaving only the fixed end of 10mm connected to the substrate (or specimen printing base plate), so that the specimen is in a cantilever beam state (see Figure 2).
NOTE 1: The height position of the truncated support is not required. The truncation process shall ensure the integrity of the specimen.
d ?€? support truncated position;
A ?€? Measurement position of warpage deformation.
NOTE 1: The allowable error is ??0.5mm.
Figure 2 -- Warpage Deformation Test
8.2.4 Mechanical properties
8.2.4.1 Hardness
The 6 specimens, after completing the test in accordance with 8.2.1, refer to the positive direction of z-axis indicated on the surface of the specimen, respectively select a test surface with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction); Polish the selected test surfaces according to the procedures specified in GB/T 13298.
Test in accordance with the provisions of GB/T 4340.1-2009.
Tests are carried out on the two test surfaces of each specimen. All 12 test surfaces of the 6 specimens shall comply with the provisions of 5.2.4.1.
8.2.4.2 Tensile properties
Test according to the provisions of 8.3~8.7 in ISO 22674-2016; it shall meet the requirements of 5.2.4.2.
8.2.4.3 Bending performance
Test according to the provisions of GB/T 3851-2015. The fulcrum distance is 20 mm; and the radius of curvature of the fulcrum and the indenter is 2 mm. The test is carried out at a speed of 1.0 mm/min; record the 0.2% specified non-proportional bending stress of the bending test. The 0.2% specified non-proportional bending stress of the 6 specimens shall meet the requirements of 5.2.4.3.
8.2.5 Inclusions and porosity
The 6 specimens, after completing the hardness test according to 8.2.4.1, shall respectively select 1 test surface with the long axis of the specimen parallel to the printing growth direction (z-axis direction) and the long axis of the specimen perpendicular to the printing growth direction (x-axis or y-axis direction). Test area fraction of looseness, non-metallic inclusions and porosity for sample according to GB/T 18876.1-2002. The selected field of view shall avoid the position of hardness indentation; and the field of view with more areas of looseness, non-metallic inclusions and pores shall be selected for calculation.
c) The roundness of the powder;
d) Powder size and distribution;
e) The fluidity of the powder;
f) Liquidus and solidus temperature (alloy), or melting point (pure metal); g) 0.2% specified non-proportional extension strength;
h) Elongation after break;
i) Young's modulus;
j) The product has an anti-tarnish statement (see 5.7), if applicable;
k) Linear expansion coefficient, if the product is used to make metal porcelain restorations;
l) The recommended maximum porcelain temperature, if the product is used to make metal porcelain restorations;
m) Recommended brazing, fusion welding and other connection techniques; n) Recommended storage conditions;
o) Detailed information about potential side effects and mark "This product contains nickel", if the nickel content in the product exceeds 0.1% (mass fraction). 9.2 Instruction manual
The detailed instruction manual shall be provided to the purchaser by the distributor and manufacturer as a package accompanying document. The specific content shall include:
a) Recommendations and information on forming and processing;
b) If metal materials are used to make metal-porcelain restorations, the processing conditions shall be explained, and instructions for satisfactory bonding surface preparation with at least one matching (designated) porcelain material that complies with ISO 9693 shall be provided;
c) The recommended heat treatment process, including stress relief heat treatment and softening and hardening heat treatment;
d) Recommendations to prevent dust inhalation during grinding;
e) The manufacturer shall provide the recommended printing parameters (including at least: laser power, scanning speed, printing distance, spot diameter and

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