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YY/T 0294.1-2024: Surgical instruments - Materials - Part 1: Metals Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0294.1: Historical versions
Similar standardsYY/T 0294.1-2024: Surgical instruments - Materials - Part 1: Metals---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0294.1-2024YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA ICS 11.040.30 CCS C 31 Replacing YY/T 0294.1-2016 Surgical instruments - Materials - Part 1.Metals (ISO 7153-1.2016, MOD) Issued on. SEPTEMBER 29, 2024 Implemented on. OCTOBER 15, 2025 Issued by. National Medical Products Administration Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 7 4 Scope of application of materials... 7 5 Materials... 11 Appendix A (Informative) Examples of dental instruments... 16 References... 17ForewordThis document was drafted in accordance with the provisions of GB/T 1.1-2020 Directives for standardization - Part 1.Rules for the structure and drafting of standardizing documents. This document is part 1 of YY/T 0294 Surgical instruments - Materials. YY/T 0294 has been published in the following parts. -- Part 1.Metals. This document replaces YY/T 0294.1-2016 Surgical instruments - Metallic materials - Part 1.Stainless steel. Compared with YY/T 0294.1-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows. -- The overview is deleted (see Chapter 3 of the 2016 edition); -- The scope of application of materials is added (see Chapter 4); -- The table of the applicable scope of stainless steel is modified (see Table 1; see Table 1 of the 2016 edition); -- The table of the applicable scope of cemented carbide is added (see Table 2); -- The table of the applicable scope of titanium and titanium alloys is added (see Table 3); -- The chapter "Materials" is added (see Chapter 5); -- The chapter "Chemical composition" is deleted (see Chapter 4 of the 2016 edition); -- The table of the stainless steel is added (see Table 4); -- The table of the correspondence between EN 10088-1.2014 and other standards is added (see Table 5); -- The table of cemented carbide is added (see Table 6); -- The table of titanium and titanium alloys is added (see Table 7). This document is modified in relation to ISO 7153-1.2016 Surgical instruments - Materials - Part 1.Metals. This document has made the following structural adjustments compared to ISO 7153- 1.2016. -- Chapter 4 corresponds to Chapter 3 of ISO 7153-1.2016; -- Chapter 5 corresponds to Chapter 4 of ISO 7153-1.2016. The technical differences between this document and ISO 7153-1.2016 and their reasons are as follows. -- The normative reference GB/T 4340.1 replaces ISO 6507-1 (see Table 4). The degree of consistency between the two documents is modification; -- The normative reference GB/T 230.1 replaces ISO 6508-1 (see Table 4). The degree of consistency between the two documents is modification; -- GB/T 20878-2007 is added (see Chapter 4, Table 1 and Table 4); -- Chinese stainless-steel grades are added to adapt to Chinese technical conditions and meet the selection of surgical instrument materials in China; -- The applicability of 12Cr18Ni9 stainless steel components is added to adapt to Chinese technical conditions and meet the selection of surgical instrument components in China (see Table 1). The following editorial changes were made to this document. -- Examples of forceps and forceps with inserts or coatings are added (see Table 1~Table 3). 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 National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Surgical Instruments of Standardization Administration of China (SAC/TC94). Drafting organizations of this document. Xinhua Surgical Instrument Co., Ltd., Heilongjiang Institute for Drug Control, Shanghai Medical Instrument (Group) Co., Ltd., and Shanghai Institute of Medical Device Testing. Main drafters of this document. Xu Xianjing, Yang Lin, Luan Renbing, Huo Dongfeng, Zhang Binbin, Cao Dongdong, Zhuang Shuxiang, Liu Liang, and Gu Ying. This document was first issued in 1997, revised for the first time in 2005, revised for the second time in 2016, and this is the third revision.1 ScopeThis document gives examples of conventional stainless-steel materials, cemented carbides, titanium and titanium alloys used to manufacture various standard surgical instruments and components, as well as information on grades and hardness ranges of commonly used materials. This document applies to the selection of metal materials used in the manufacture of surgical instruments, including but not limited to general surgical, orthopedic, and dental instruments. NOTE 1.Although this document is not intended to apply to surgical instruments for special applications such as implantology and minimally invasive surgery, some parts of it may be applicable to these instruments. NOTE 2.When selecting metal materials, manufacturers need to consider the instrument design and factory manufacturing in addition to the metal grade, shape, size, and delivery status. Therefore, manufacturers are responsible for the selection of materials and shall not exclude the possibility of referring to other current standards. When appropriate standards are released, the applicability of new standards needs to be considered.2 Normative referencesThe provisions of the following documents constitute the essential clauses of this document through normative references in this text. Among them, for referenced documents with dates, only the versions corresponding to the dates are applicable to this document; for referenced documents without dates, the latest versions (including all amendments) are applicable to this document. GB/T 230.1 Metallic materials - Rockwell hardness test - Part 1.Test method (GB/T 230.1-2018, ISO 6508-1.2016, MOD) GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1.Test method (GB/T 4340.1-2009, ISO 6507-1.2005, MOD) GB/T 20878-2007 Stainless and heat-resisting steels - Designation and chemical composition ISO 5832-2 Implants for surgery - Metallic materials - Part 2.Unalloyed titanium ISO 5832-3 Implants for surgery - Metallic materials - Part 3.Wrought titanium 6- aluminium 4-vanadium alloy ASTM B 265 Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate ASTM B 348 Standard Specification for Titanium and Titanium Alloy Bars and Billets EN 10088-1.2014 Stainless steels Part 1.List of stainless steels3 Terms and definitionsThere are no terms or definitions that require definition in this document.4 Scope of application of materialsBecause various surgical instruments have different needs and different requirements for the materials used to make them, not all materials listed in Chapter 5 are suitable for every type of instrument. For most types of surgical instruments, Tables 1~3 give materials that are suitable for these instruments based on known experience. Other materials may also be suitable for the manufacture of certain types of instruments, although these materials are not included in this document. Table 1 lists the conventional stainless-steel materials used to manufacture various standard surgical instruments and components. The codes in the first column correspond to the stainless-steel materials specified in Table 4.In addition, the codes in the second column are from ISO 7153-1.1991, and the grades in the third column are from GB/T 20878-2007.The information in the second and third columns is only for users familiar with YY/T 0294.1-2016.5 MaterialsTable 4 gives the grades of commonly used stainless steels for various surgical instruments. In addition, the Rockwell hardness and Vickers hardness values of the materials are given where possible. a For the conversion between Rockwell hardness value and Vickers hardness value, refer to Table A.1 of GB/T 33362-2016.1 HRC is added to the calculated HV5/HV10 value (based on the empirical value of stainless steel). This document does not give the Vickers hardness values of other loads. b Material numbers in brackets are not included in EN 10088-1; the materials are included in this table only. c Historically, material number 1.4121 has been used in other areas, but the material grade is the same. 1.4197 is used for rotating surgical tools. Code (see Table 1) Table 5 gives the material classification correspondence between EN 10088-1.2014 and other relevant steel standards. All information in Table 5 is for reference only by users of this document and is not normative. The second column establishes a correspondence between the material number of EN 10088-1.2014 and the material code and chemical composition given in ISO 7153-1.1991.Since the material number in EN 10088-1.2014 does not directly correspond to the code in ISO 7153-1.1991 in all cases, the third and fifth columns give indications when the chemical composition is the same, very similar or essentially different.Appendix A(Informative) Examples of dental instruments YY/T 0294.1-2016 lists detailed surgical instruments and examples of stainless steel commonly used in processing. This information is particularly helpful for dental instruments. In some cases, dental instruments cannot be simply classified into the instrument types given in Table 1.Therefore, when updating this part of the information, the application examples of dental instruments are given in Table A.1.For commonly used component materials, refer to Table 1 and Table 3. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0294.1-2024 be delivered?Answer: The full copy PDF of English version of YY/T 0294.1-2024 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 0294.1-2024_English with my colleagues?Answer: Yes. 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