GB/T 46944-2025Surgical instruments - Functional structure and connecting fasteners of scissors, forceps, tweezers and retractors (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Instruments (SAC/TC94). This document was drafted by: Shanghai Institute for Medical Device Testing, Shanghai Medical Devices (Group) Co., Ltd. Surgical Instruments Factory, and Xinhua Surgical Instruments Factory. Technical Instruments Co., Ltd., Shenzhen Institute for Drug Control (Shenzhen Medical Device Testing Center), and Zhejiang Provincial Medical Device Evaluation Center. The main drafters of this document are. Yang Lin, Hua Songhe, Xu Xianjing, Gu Ying, Zhang Binbin, Cao Dongdong, Wang Shuhan, Zhang Kunzhi, and Peng Sirui. Surgical instruments. scissors, forceps, tweezers, retractors Functional structure and connecting fasteners

1 Scope

GB/T 46944-2025 is the Chinese national standard covering the joints and fasteners of hinged surgical instruments - the box lock and screw joint, the play that develops with use, the ratchet, and the requirement that every crevice can be cleaned and sterilised. First edition, in force from 1 January 2027, under the National Medical Products Administration. It was issued on 31 December 2025 and takes effect on 1 January 2027, as a first edition. The document is under the responsibility of the National Medical Products Administration. This page is published from the official record of the 2025 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

This document outlines the functional structure of surgical instruments such as scissors, forceps, tweezers, and retractors, as well as the classification and naming of connecting fasteners. It also specifies the materials, The requirements describe the corresponding experimental methods. This document applies to the design of surgical instruments such as scissors, forceps, tweezers, and retractors.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB/T 230.1 Metallic materials - Rockwell hardness test - Part

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 gill joint The connection point between the left and right structural components.

Note. Commonly found in scissors, pliers, and some retractors.

3.2 lip hook tooth Hooks and grooves that mesh with each other at the working end of the instrument.

Note. Commonly found in forceps and tweezers.

3.3 lip and tooth serration Serrated surface at the working end of the instrument.

Note. Commonly found in forceps and tweezers.

3.4 Rings The ring-shaped part can be used to control the opening and closing of the device by hand.

Note. Generally, at least one finger can be inserted into the ring at the end of the handle of the instrument. This is commonly found in scissors, pliers, and some retractors.

3.5 Locking teeth ratchet The structure allows the device to be gradually locked, held in a locked or open state by controlling the finger rings.

Note. Commonly found in clamps and some retractors.