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YY 0117.2-2024: Implants for surgery - Forgings, castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings
Status: Valid YY 0117.2: Evolution and historical versions
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| YY 0117.2-2024 | English | 209 |
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Implants for surgery - Forgings, castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings
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YY 0117.2-2024
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| YY 0117.2-2005 | English | 110 |
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Implants for surgery - Forgings, castings for bone joint prostheses - ZTi6A14V titanium alloy castings
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YY 0117.2-2005
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| YY 0117.2-1993 | English | 199 |
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(Surgical implants of bone and joint prosthesis forging, casting alloy castings ZTiA16V4)
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YY 0117.2-1993
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PDF similar to YY 0117.2-2024
Basic data | Standard ID | YY 0117.2-2024 (YY0117.2-2024) | | Description (Translated English) | Implants for surgery - Forgings, castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,146 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0117.2-2005 | | Issuing agency(ies) | State Drug Administration | YY 0117.2-2024: Implants for surgery - Forgings, castings for bone joint prostheses - Part 2: ZTi6Al4V titanium alloy castings
---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 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0117.2-2005
Surgical implants, bone and joint prostheses, forgings and castings
Part 2.ZTi6Al4V titanium alloy castings
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
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.
This document is part 2 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 0117.2-2005 "Surgical Implant Bone and Joint Prosthesis Forgings and Castings ZTi6A14V Titanium Alloy Castings" and
Compared with YY 0117.2-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Deleted the requirements for casting process (see 3.4 of the.2005 edition);
--- Changed the internal quality requirements. The allowable level of internal defects can meet the requirements of both the supplier and the buyer in accordance with the Appendix of YY/T 1565-2017.
A recommended acceptable limit agreed limit (see 4.5, 3.7 of the.2005 edition);
--- Changed the test method for chemical composition analysis and added other recognized analysis methods (existing ISO methods or national standards, industry standards, etc.)
Methods recommended by industry standards) (see 5.1, 4.1 of the.2005 edition);
--- Added test methods for surface contamination (see 5.3.1);
--- Changed the test method for surface roughness. In addition to the sample comparison method, the test method of GB/T 10610 was added (see 5.3.3,
4.5 of the.2005 edition);
--- Changed the test method for surface quality, added magnifying glass and fluorescent penetrant inspection methods (see 5.3.4, 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, Beijing
Chunli Zhengda Medical Equipment Co., Ltd.
The main drafters of this document are. Xiong Zhenguo, Qin Geji, Liu Dacheng, Fu Ruizhi, Zhu Jinqing, Sun Jiayi, Wu Jing, Zhang Yidan, Li Niya,
Lu Minqi, Zhang Chun, and Xie Fengbao.
The previous versions of this document and the documents it replaces are as follows.
---First issued in.1993 as YY 0177.2-1993, 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 2.ZTi6Al4V titanium alloy castings
1 Scope
This document specifies the requirements, test methods, inspection and quality control of surgical implant bone and joint prosthesis castings made of ZTi6Al4V titanium alloy material.
Regulations, quality certification, labeling, packaging, transportation and storage.
This document applies to the production and acceptance of ZTi6Al4V titanium alloy castings 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 10610 Geometric Product Specification (GPS) Rules and methods for evaluating surface structure by surface structure profile method
GB/T 23603 Detection method for surface contamination layer of titanium and titanium alloys
HB6103 Casting Dimension Tolerance and Machining Allowance
HB6573 Standard reference radiographs for investment steel castings
HB20160 X-ray photography inspection
YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants
YY/T 1565-2017 Non-destructive testing of surgical implants - Radiographic testing of cast metal surgical implants
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Requirements
4.1 Raw materials
4.1.1 The raw materials for manufacturing bone and joint prosthesis castings should be ingots or forged bars. The ingots should be subjected to two or more vacuum or inert
The forged rod is a rod obtained by forging the above-mentioned ingot and removing the oxide scale under gas protection.
4.1.2 The castings and test specimens may be cast from the same master alloy or from the same smelting furnace batch of a master alloy.
4.2 Chemical composition
Carry out the test according to the method described in 5.1.The chemical composition of the casting shall conform to the provisions 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.
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