标准编号:	YY/T 1122-2017
中文名称:	咬骨钳（剪）通用技术条件
英文名称:	General technique requirememts for orthopaedics clamp(scissor)
行业分类:	YY    医药行业标准
发布机构:	国家食品药品监督管理总局
发布日期:	2017-03-28
实施日期:	2018-4-1
标准状态:	valid
替代旧标准:	YY 1122-2005 咬骨钳(剪)通用技术条件 YY/T 1127-2006 咬骨钳
翻译语言:	英文
文件格式:	PDF
中文字符数:	8000 字
翻译价格(元):	290.0
交付时间:	付款后 1 个工作日

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