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US$219.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1910-2023: Medical-grade beta-tricalcium phosphate powder for additive manufacturing Status: Valid
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Medical-grade beta-tricalcium phosphate powder for additive manufacturing
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YY/T 1910-2023
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Basic data | Standard ID | YY/T 1910-2023 (YY/T1910-2023) | | Description (Translated English) | Medical-grade beta-tricalcium phosphate powder 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 | 11,139 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements, test methods, labeling, packaging, transportation and storage of medical beta-tricalcium phosphate powder for additive manufacturing. This standard applies to medical beta-tricalcium phosphate powder produced by light-curing, extrusion and powder-laying additive manufacturing processes. |
YY/T 1910-2023: Medical-grade beta-tricalcium phosphate powder 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 beta-tricalcium phosphate powder for additive manufacturing
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction II
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Performance requirements 1
5 Test method 3
6 Labeling, packaging, transportation and storage 4
Appendix A (Normative) β-tricalcium phosphate X-ray diffraction spectrum 5
Reference 6
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the China Institute for Food and Drug Control.
This document was drafted by. Dianyun Biotechnology (Hangzhou) Co., Ltd., China Institute of Food and Drug Control, Maihai New Material Technology (Gu'an)
Co., Ltd., Northwestern Polytechnical University, Zhejiang University of Science and Technology, South China University of Technology Medical Device Research and Inspection Center, Sichuan Medical Device Biomaterials
and Products Inspection Center Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, National Human Tissue Function Reconstruction Engineering Technology Research Center
Center, Zhejiang Institute of Medical Device Inspection, Shanghai Biolu Biomaterials Co., Ltd., Zhejiang Epuri Nano New Materials Co., Ltd.,
Suzhou Ding'an Technology Co., Ltd.
The main drafters of this document. Zeng Qingfeng, Wei Jing, Han Qianqian, Mao Xin, Liu Zhenqi, Yu Shuyin, Liu Yongsheng, Kong Xiangdong, Liu Jia, Deng Xiang, Ma Chunbao,
Ren Li, Xu Pinghua, Lu Xiao, Ni Chenghui, Li Yadong.
Introduction
Medical β-tricalcium phosphate powder is suitable for a variety of additive manufacturing processes, such as stereolithography, binder injection, powder bed fusion and extrusion.
Craftsmanship. Due to different additive manufacturing processes, the particle size and distribution, powder morphology, specific surface area, bulk density, and vibration of medical β-tricalcium phosphate powder are affected.
The requirements for solid density and fluidity are different, so it needs to be controlled based on the specific process type and product quality requirements.
Medical beta-tricalcium phosphate powder for additive manufacturing
1 Scope
This document specifies the performance requirements, test methods, labeling, packaging, transportation and
Storage.
This document applies to medical beta-tricalcium phosphate powder produced by light-curing, extrusion and powder-laying additive manufacturing processes.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 19077 Particle size distribution laser diffraction method
GB/T 19587 Determination of specific surface area of solid materials by gas adsorption BET method
GB 23101.3 Hydroxyapatite for surgical implants Part 3.Chemical analysis and characterization of crystallinity and phase purity
GB/T 35021 Additive manufacturing process classification and raw materials
GB/T 35351 Additive Manufacturing Terminology
GB/T 39696 Standard funnel method for determination of flowability of fine ceramic powders
YY/T 0683-2008 β-tricalcium phosphate for surgical implants
ISO 23145-1 Determination of bulk density of fine ceramics (advanced ceramics, high-tech ceramics) ceramic powders Part 1.Tap density
ceramicpowders-Part 1.Tapdensity]
ISO 23145-2 Determination of bulk density of fine ceramics (advanced ceramics, high-tech ceramics) ceramic powders Part 2.Uncompacted dense
ceramicpowders-Part 2.Untappeddensity]
Pharmacopoeia of the People's Republic of China (2020 edition, four volumes)
3 Terms and definitions
The terms and definitions defined in GB/T 35021 and GB/T 35351 apply to this document.
4 Performance requirements
4.1 Appearance
It should be white powder with no visible colored matter.
4.2 X-ray diffraction
It should be consistent with the characteristic peaks in the X-ray diffraction spectrum of β-tricalcium phosphate in Appendix A [diffraction angles (2θ) are approximately 27.8°, 31.0°, and 34.4° respectively]
consistent.
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