Search result: YY 0117.1-2024 (YY 0117.1-2005 Older version)
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Implants for surgery - Forgings, castings for bone joint prostheses - Part 1: Ti6Al4V titanium alloy forgings
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YY 0117.1-2024
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| YY 0117.1-2005 | English | 199 |
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Implants for surgery. Forgings, castings for bone joint prostheses. Ti6A14V titanium alloy forgings
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YY 0117.1-2005
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| YY 0117.1-1993 | English | 439 |
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(Surgical implants of bone and joint prosthesis forging, casting TC4 titanium alloy forgings)
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YY 0117.1-1993
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| Standard ID | YY 0117.1-2024 (YY0117.1-2024) | | Description (Translated English) | Implants for surgery - Forgings, castings for bone joint prostheses - Part 1: Ti6Al4V titanium alloy forgings | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,141 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0117.1-2005 | | Issuing agency(ies) | State Drug Administration |
YY 0117.1-2024. Surgical implants for bone and joint prostheses forgings and castings Part 1. Ti6Al4V titanium alloy forgings
ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0117.1-2005
Surgical implants, bone and joint prostheses, forgings and castings
Part 1.Ti6Al4V titanium alloy forgings
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Preface
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.
This document is part 1 of YY 0117 "Surgical Implants - Bone and Joint Prosthesis Forgings and Castings". YY 0117 has been issued as follows
part.
--- Part 1.Ti6Al4V titanium alloy forgings;
--- Part 2.ZTi6Al4V titanium alloy castings;
--- Part 3.Cobalt-chromium-molybdenum alloy castings.
This document replaces YY 0117.1-2005 "Surgical Implant Bone and Joint Prosthesis Forgings and Castings Ti6A14V Titanium Alloy Forgings" and
Compared with YY 0117.1-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Deleted the processing requirements for raw materials (see 3.1.1 of the.2005 edition);
--- Changed the annealing specification (see note to 4.2, 3.2.2 of the.2005 edition);
--- Deleted the note on the Brinell hardness of forging surface as a reference (see Table 2 of the.2005 edition);
--- Changed the requirements for microstructure (see 4.6.3, 3.6.3 of the.2005 edition);
--- Changed the test method for chemical composition analysis and added other recognized analysis methods (existing ISO methods or national standards,
Methods recommended by industry standards) (see 5.1, 4.1 of the.2005 edition);
--- Changed the test method for surface roughness. In addition to the sample comparison method, the test method of GB/T 10610 was added (see 5.3.2,.2005
4.6 of the year);
--- Changed the test method for the flatness of forgings, adding "according to the method specified in GB/T 11337 or agreed upon by both parties".
(see 5.5.2, 4.5 of the.2005 edition).
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 National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This document was drafted by. Beijing Youcai Jinghang Biotechnology Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, National Drug Administration
Medical Device Technical Review Center of the State Food and Drug Administration, Greater Bay Area Center for Medical Device Technical Review and Inspection of the State Food and Drug Administration, Suzhou Microelectronics
Chuang Joint Medical Technology Co., Ltd.
The main drafters of this document are. Xiong Zhenguo, Qin Geji, Liu Xiaoye, Zhang Chen, Ma Hui, Guo Xiaolei, Aruhan, Zhai Bao, Zhang Kun, Li Niya,
Shen Hainan, Li Xuan, and Yu Tianbai.
The previous versions of this document and the documents it replaces are as follows.
---First issued in.1993 as YY 0117.1-1993, first revised in.2005;
---This is the second revision.
introduction
YY 0117 "Surgical Implant Bone and Joint Prosthesis Forgings and Castings" consists of 3 parts.
--- Part 1.Ti6Al4V titanium alloy forgings;
--- Part 2.ZTi6Al4V titanium alloy castings;
--- Part 3.Cobalt-chromium-molybdenum alloy castings.
Due to the different materials used to manufacture forgings and castings of bone and joint prostheses, the corresponding performance indicators and test methods are different.
The series of standards are divided into three parts, which respectively regulate forgings and castings of bone and joint prostheses made of different materials. This revision is a summary of the original standards.
and improvement, aiming to standardize the manufacturing and quality control of forgings and castings of bone and joint prostheses.
Surgical implants, bone and joint prostheses, forgings and castings
Part 1.Ti6Al4V titanium alloy forgings
1 Scope
This document specifies the requirements, tests and specifications for the manufacture of surgical implant bone and joint prosthesis forgings using surgical implant Ti6Al4V titanium alloy processed materials.
Methods, inspection rules, quality certification, labeling, packaging, transportation and storage.
This document applies to the production and acceptance of Ti6Al4V titanium alloy forgings for bone and joint prostheses.
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 228.1 Tensile test of metallic materials Part 1.Room temperature test method
GB/T 4698 (all parts) Chemical analysis methods for titanium sponge, titanium and titanium alloys
GB/T 5168 Titanium and titanium alloy macrostructure inspection method
GB/T 10610 Geometric Product Specification (GPS) Rules and methods for evaluating surface structure by surface structure profile method
GB/T 11337 Flatness error detection
YY/T 0512-2009 Classification of microstructure of α β titanium alloy rods for surgical implants
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Requirements
4.1 Chemical composition
Carry out the test according to the method described in 5.1.The chemical composition of the forgings shall conform to the requirements of Table 1.
Other elements generally include. Sn, Mo, Cr, Mn, Zr, Ni, Cu, Si, Y (the alloy elements contained in this grade should be removed).
The following items may not be tested. When the purchaser deems it necessary, random inspection may be carried out. The results of random inspection shall comply with the provisions of Table 1.
Table 1 Chemical composition of forgings
Main ingredients Impurities
Elements Al V Ti Fe CNHO Other Elements
Mass fraction/% 5.5~6.75 3.5~4.5 Matrix ≤0.30 ≤0.08 ≤0.05 ≤0.010 ≤0.20
Single sum
≤0.10 ≤0.40
Note. The hydrogen content is determined on the forgings in the supplied state.
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