YY/T 1122-2017 General technique requirements for orthopaedics clamp (scissor)
1 Scope
This standard specifies the materials, hardness, corrosion resistance, surface quality, basic dimensions, service performance, test methods and marking of orthopaedics clamps (scissors).
This standard is applicable to orthopaedics clamps (scissors) for biting/cutting or correcting bones.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 230.1 Metallic materials - Rockwell hardness test - Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T)
GB/T 1220 Stainless steel bars
GB/T 1910 Newsprint
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture
GB/T 22822 Thick board
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY/T 0294.1 Surgical instruments - Metallic materials - Part 1: Stainless steel
YY/T 1052 Marking requirements for surgical instruments
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
orthopaedics clamp (scissor)
single-joint or double-joint orthopedic instrument for biting/cutting or correcting bones
4 Requirements
4.1 Materials
The heads of the orthopaedics clamps (scissors) may be made of the materials specified in GB/T 1220, YY/T 0294.1 or ASTM F899, or other materials of better quality.
4.2 Hardness
The hardness of the heads of orthopaedics clamps (scissors) shall not be less than 40 HRC or 400 HV10, and the hardness difference between the left and right head pieces shall not be greater than 4 HRC or 40 HV10. In addition, the enterprise shall also specify the maximum hardness of the orthopaedics clamps (scissors).
4.3 Corrosion resistance
The corrosion resistance of the outer surfaces of orthopaedics clamps (scissors) shall not be inferior to Class b of boiling water method specified in YY/T 0149-2006.
4.4 Surface quality
4.4.1 Surface roughness
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking
Bibliography
YY/T 1122-2017 General technique requirements for orthopaedics clamp (scissor)
1 Scope
This standard specifies the materials, hardness, corrosion resistance, surface quality, basic dimensions, service performance, test methods and marking of orthopaedics clamps (scissors).
This standard is applicable to orthopaedics clamps (scissors) for biting/cutting or correcting bones.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 230.1 Metallic materials - Rockwell hardness test - Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T)
GB/T 1220 Stainless steel bars
GB/T 1910 Newsprint
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture
GB/T 22822 Thick board
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY/T 0294.1 Surgical instruments - Metallic materials - Part 1: Stainless steel
YY/T 1052 Marking requirements for surgical instruments
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
orthopaedics clamp (scissor)
single-joint or double-joint orthopedic instrument for biting/cutting or correcting bones
4 Requirements
4.1 Materials
The heads of the orthopaedics clamps (scissors) may be made of the materials specified in GB/T 1220, YY/T 0294.1 or ASTM F899, or other materials of better quality.
4.2 Hardness
The hardness of the heads of orthopaedics clamps (scissors) shall not be less than 40 HRC or 400 HV10, and the hardness difference between the left and right head pieces shall not be greater than 4 HRC or 40 HV10. In addition, the enterprise shall also specify the maximum hardness of the orthopaedics clamps (scissors).
4.3 Corrosion resistance
The corrosion resistance of the outer surfaces of orthopaedics clamps (scissors) shall not be inferior to Class b of boiling water method specified in YY/T 0149-2006.
4.4 Surface quality
4.4.1 Surface roughness
Contents of YY/T 1122-2017
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking
Bibliography