YY/T 0294.1-2024: Surgical instruments - Materials - Part 1: Metals

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Scope

This 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.

Basic Data

Standard ID	YY/T 0294.1-2024 (YY/T0294.1-2024)
Description (Translated English)	Surgical instruments - Materials - Part 1: Metals
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.30
Word Count Estimation	18,122
Date of Issue	2024-09-29
Date of Implementation	2025-10-15
Older Standard (superseded by this standard)	YY/T 0294.1-2016
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the conventional stainless steel materials, cemented carbide, titanium and titanium alloy examples for manufacturing various standard surgical instruments and parts, as well as the grades and hardness range information of commonly used materials. This standard applies to the selection of metal materials used in the manufacture of surgical instruments. Surgical instruments include but are not limited to general surgery, orthopedic surgery and stomatology instruments.