Search result: YY 0117.2-2024 (YY 0117.2-2005 Older version)
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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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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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| 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Count Estimation | 10,146 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0117.2-2005 | | Drafting Organization | Beijing Youcai Jinghang Biotechnology Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Beijing Chunli Zhengda Medical Device Co., Ltd. | | Administrative Organization | National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration |
YY 0117.2-2024. Surgical implants for bone and joint prostheses forgings and castings Part 2. ZTi6Al4V titanium alloy castings
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
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 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.
......
YY 0117.2-2005
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0117.2-1993
Implants for surgery - Forgings, castings for bone joint
prostheses - ZTi6Al4V titanium alloy castings
ISSUED ON: DECEMBER 07, 2005
IMPLEMENTED ON: DECEMBER 01, 2006
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements ... 4
4 Test method ... 7
5 Inspection rules ... 7
6 Quality certificate ... 9
7 Marking, packaging, transportation, storage ... 9
Appendix A (Normative) Special requirements for defect repair, repair welding and
correction of surgical implants - ZTi6Al4V titanium alloy castings for bone joint
prostheses ... 10
Implants for surgery - Forgings, castings for bone joint
prostheses - ZTi6Al4V titanium alloy castings
1 Scope
This Part of YY 0117 specifies the requirements, test methods, inspection rules, quality
certification, marking and packaging of implants for surgery - forgings, castings for
bone joint prostheses - ZTi6Al4V titanium alloy castings.
This Part applies to the production and acceptance of ZTi6Al4V titanium alloy castings
for bone joint prosthesis.
2 Normative references
The provisions in following documents become the provisions of this Part through
reference in this Part of YY 0117. For the dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Part; however, parties who
reach an agreement based on this Part are encouraged to study if the latest versions of
these documents are applicable. For undated references, the latest edition of the
referenced document applies.
GB/T 228 Metallic materials - Tensile testing at ambient temperature (GB/T 228-
2000, eqv ISO 6892:1998)
GB/T 4698 Chemical analysis methods for titanium and titanium alloys
YY 0341 General technological requirements for non-active metallic surgical
implants for osteosynthesis
HB/Z 60 X-ray radiographic inspection
HB 5448 Titanium and titanium alloy investment castings
HB 6103 Dimensional tolerances of castings
HB 6573 Standard reference radiographs for investment steel castings
3 Requirements
3.1 Master alloy
process for not more than 10 smelting furnaces.
5.2 Chemical analysis
5.2.1 Specimens can be cut from cast test bars, casting systems or castings.
5.2.2 Take a specimen from each batch of castings for analysis. When the analysis result
is unqualified, it is allowed to retake the specimen, from the test bar, casting system or
casting that is sampled for the first time, to retest the unqualified elements. If the re-test
results are still unqualified, samples shall be taken from furnace one by one for analysis
of all items. The castings of unqualified furnace numbers shall be disqualified.
5.3 Mechanical properties
5.3.1 The mechanical properties of castings can be tested, by using the attached casting
specimens OR cutting specimens from castings. It shall be inspected according to the
requirements of 3.5.
5.3.2 Take two tensile specimens from each furnace batch of castings; inspect them
according to the requirements in Table 2.
5.3.3 When one specimen is unqualified in the test results, it is allowed to take double
quantity of specimens from the same batch of castings for re-inspection. If the re-
inspection result still has one disqualified piece, it is allowed to take specimen from
each furnace for test. The castings from unqualified furnaces are disqualified.
5.3.4 Tensile specimens for mechanical performance testing shall, according to the
provisions of GB/T 228, select a proportioned specimen, which has a diameter of Φ5
mm and a gauge length of 25 mm.
5.4 Surface quality
Castings shall be 100% inspected for surface quality, according to the requirements of
3.6.
5.5 Internal quality
5.5.1 Castings shall be 100% X-ray inspected, according to the requirements in Table
4.
5.5.2 When the buyer requires metallographic inspection, the inspection shall be carried
out, according to the special technical documents as negotiated by the supplier and the
buyer.
5.6 Casting shape and size
The shape and size of castings are 100% inspected, according to the requirements of
3.8.
5.7 Correction and repair welding
See Appendix A, for the correction and repair welding inspection requirements of
casting defects. It is carried out, according to the special technical documents, as
negotiated between the supplier and the purchaser.
6 Quality certificate
Each batch (number) of castings shall be accompanied by a quality inspection report.
The report shall state the following: supplier name, casting name (code), alloy
designation, furnace batch number of castings, supply status of castings, quantity of
castings, inspection results of casting numbers, this standard number, date of exit-
factory, etc.
7 Marking, packaging, transportation, storage
7.1 Marking
Steel stamps are not allowed on the castings; however, the steel number (referring to
the casting number) can be printed on the gate or riser of the casting.
7.2 Packaging, transportation, storage
7.2.1 Castings shall be packed well. The same batch of castings shall be packaged in
the same package, to prevent mechanical damage, surface pollution, deformation and
other influences, during transportation. The package shall indicate the making
organization, address, zip code, casting name, material designation, furnace batch
number, casting quantity, etc.
7.2.2 The requirements for preventing mechanical damage shall be indicated during the
transportation of castings.
7.2.3 Pollution, corrosion and rust shall be prevented during the storage of castings; it
shall be stored in a neat and orderly manner.
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