GB/T 2766-2022 Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods
1 Scope
This document specifies the materials, requirements, test methods, and marking of non-cutting, articulated instruments.
This document is applicable to non-cutting, articulated instruments.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 230.1-2018 Metallic materials - Rockwell hardness test - Part 1: Test method (ISO 6508-1:2016, MOD)
Note: There is no technical difference between the referenced content from GB/T 230.1-2018 and that from ISO 6508:1986.
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2005, MOD)
Note: There is no technical difference between the referenced content from GB/T 4340.1-2009 and that from ISO 6507-1:1982.
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402:1995, MOD)
YY/T 0294.1-2016 Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO 7153-1:1991, MOD)
Note: There is no technical difference between the referenced content from GB/T 0294.1-2016 and that from ISO 7153-1:1983.
3 Terms and definitions
No terms and definitions are listed in this document.
4 Materials
The non-cutting, articulated instruments (hereafter referred to as "the instruments"), except for inserts, should be made of the materials specified in Table 1 or Clause 5.
Table 1 Material grade
Instrument and component parts Material grade
YY/T 0294.1-2016 Others
Non-cutting, articulated instruments (excluding retractors) 32Cr13Mo 20Cr13 and 05Cr17Ni4Cu4Nb 2Cr13Mo and titanium alloy (TC3 and TC4)
Retractors Blade 12Cr13 and 06Cr19Ni10 -
Body Small 12Cr13
Large -
Rivets and screws 12Cr13, 10Cr17, 06Cr19Ni10, 12Cr18Ni9, 12Cr17Ni7 and 06Cr17Ni12Mo2
If the instrument body needs to hold a high-hardness instrument (such as a needle), other materials of higher hardness may be selected, and the instrument shall meet the requirements of Clause 5 (excluding heat treatment and hardness of the component parts).
5 Requirements
5.1 Heat treatment and hardness for component parts, excluding rivets and screws and parts manufactured of 06Cr19Ni10 material
5.1.1 Heat treatment
The component parts of the instruments shall be heat-treated under suitable conditions to ensure compliance with the requirements of 5.1.2 and 5.1.3 for the material used.
Note: If other materials are selected, the hardness of heat treatment shall correspond to the relevant heat treatment specifications.
5.1.2 Hardness of instruments
The Rockwell hardness of the finished instruments shall be within the range 40 HRC to 48 HRC (approximately equivalent to a Vickers hardness range of 390 HV to 485 HV) and the Rockwell hardness of 05Cr17Ni4Cu4Nb material shall be within the range 36 HRC to 44 HRC (approximately equivalent to a Vickers hardness range of 330 HV to 410 HV) when tested in accordance with GB/T 230.1-2018 and GB/T 4340.1-2009 respectively. Mating surfaces on the same instrument shall not vary in hardness by more than 4 units on the Rockwell hardness scale or 40 units on the Vickers hardness scale.
Note: The test force shall be determined by the manufacturer based on the characteristics of the product.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
6 Test methods
7 Marking
Annex A (Informative) Structural changes between this document and ISO 7151:1988
Bibliography
