YY/T 0294.1-2024 Surgical instruments — Materials — Part 1: Metals
1 Scope
This document gives examples of conventional stainless steels, hard metals, titanium and titanium alloys for the manufacture of standard surgical instruments and components, as well as information on the designations and hardness ranges of commonly used materials.
This document is applicable to the selection of metal materials for manufacture of surgical instruments. Surgical instruments including but not limited to those used in general surgery, orthopaedics and dentistry.
Note 1: While this document is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
Note 2: When selecting the designation of steel and the shape, dimensions and delivery conditions of the raw material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design of the instrument or the production facilities of the manufacturer. Therefore, the manufacturer is responsible for selection of materials and does not exclude the possibility of reference to other existing standards. When a suitable standard is published, the applicability of the new standard should be considered.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendments) applies.
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 steels
3 Terms and definitions
No terms and definitions are listed in this document.
4 Fields of application of materials
Since there are different requirements to various surgical instruments, there also have to be different requirements to the materials from which the instruments are manufactured. For this reason, not all of the materials listed within Clause 5 are suited to use in every type of instrument. For most types of surgical instruments, materials are given in Tables 1 to 3 which are known from experience to be suitable for those instruments. Although it might be possible that other materials are also suited to the manufacture of some types of instruments, this is not covered by this document.
Table 1 indicates which stainless steels are commonly used to manufacture various types of standard instruments and instrument components. In the first column, a reference letter is given pointing to the stainless steels specified within Table 4. In addition, the second column gives the respective reference letters used within ISO 7153:1991, and the third column gives the respective reference letters used within GB/T 20878-2007. This additional information is only provided as a courtesy for users of YY/T 0294.1-2016 who are familiar with the previous version.
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Fields of application of materials
5 Materials
Annex A (Informative) Examples of dental instruments
Bibliography
