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US$199.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1940-2024: Medical nickel titanium powders for additive manufacturing Status: Valid
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Medical nickel titanium powders for additive manufacturing
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YY/T 1940-2024
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Basic data | Standard ID | YY/T 1940-2024 (YY/T1940-2024) | | Description (Translated English) | Medical nickel titanium powders for additive manufacturing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,153 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements, labeling, packaging, transportation and storage of medical nickel-titanium alloy powders for additive manufacturing, and specifies the corresponding test methods. This standard applies to medical nickel-titanium alloy powders for powder bed fusion additive manufacturing processes using laser or electron beam as energy source. |
YY/T 1940-2024: Medical nickel titanium powders for additive manufacturing---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.30
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Medical Nitinol Powders for Additive Manufacturing
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Performance requirements 1
5 Test methods 3
6 Labeling, packaging, transportation and storage 4
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the technical standardization authority for medical additive manufacturing technology and medical devices.
This document was drafted by. Xi'an Ouzhong Materials Technology Co., Ltd., China Food and Drug Inspection Institute, Beijing Keyi Bangen Medical Devices
Technology Co., Ltd., Xi'an University of Technology, Northwestern Polytechnical University, Xi'an Juneng Medical Technology Co., Ltd., Northwest Institute of Nonferrous Metals, Shaanxi
Provincial Medical Device Quality Inspection Institute, The Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
The main drafters of this document are. Wang Qingxiang, Guo Qian, Hao Yongqiang, Han Qianqian, Mao Xin, Jia Qinggong, Jiao Hua, Yang Haiou, Yu Sen, Xue Sa, Liu Like,
Li Lijuan and Deng Liang.
Medical Nitinol Powders for Additive Manufacturing
1 Scope
This document specifies the performance requirements, labeling, packaging, transportation and storage of medical nickel-titanium alloy powders used in additive manufacturing, and describes the corresponding
test method.
This document applies to medical nickel-titanium alloy powders manufactured by powder bed fusion additive manufacturing process using laser or electron beam as energy source.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 1479.1 Determination of bulk density of metal powders Part 1.Funnel method
GB/T 1480 Metal powder dry sieving method for particle size determination
GB/T 1482 Determination of the fluidity of metal powders - Standard funnel method (Hall flowmeter)
GB/T 4698.7 Chemical analysis methods for titanium sponge, titanium and titanium alloys - Determination of oxygen and nitrogen content
GB/T 4698.14 Chemical analysis methods for titanium sponge, titanium and titanium alloys - Determination of carbon content
GB/T 4698.15 Chemical analysis methods for titanium sponge, titanium and titanium alloys - Determination of hydrogen content
GB/T 5162 Determination of tap density of metal powders
GB/T 5314 Powder sampling method for powder metallurgy
GB/T 19077 Particle size analysis by laser diffraction method
GB/T 23614.1 Chemical analysis methods for titanium-nickel shape memory alloys Part 1.Determination of nickel content Dimethylglyoxime precipitation separation
EDTA complexation-zinc chloride back titration method
GB/T 23614.2 Chemical analysis methods for titanium-nickel shape memory alloys Part 2.Determination of cobalt, copper, chromium, iron and niobium content Inductively coupled
Plasma Optical Emission Spectroscopy
GB/T 35351 Terminology for Additive Manufacturing
GB/T 41978 Test method for hollow powder rate of metal powders for additive manufacturing
YS/T 1297 Determination of sphericity of titanium and titanium alloy powders
3 Terms and definitions
The terms and definitions defined in GB/T 35351 apply to this document.
4 Performance requirements
4.1 Chemical composition
The chemical composition of medical nickel-titanium alloy powder used for additive manufacturing should comply with the requirements of Table 1.
The Ti content is determined by the difference method, Ti remainder = 100% - Ni content - impurity content.
When the purchaser has special requirements, they shall be determined through negotiation between the supply and demand parties.
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