CurrentMandatory
Industry
Medical devices
Medical electrical equipment, protective products, disinfection, sterilization, device safety and health-sector standards.
363Matched mandatory standards
8Active topic clusters
Industry guide
Medical device GB records should be checked with NMPA classification, registration standards, product technical requirements, and transition notices. The GB 9706 series is a common starting point.
349 recordsPage 14 of 20
CurrentMandatory
CurrentMandatory
GB 4234.1-2017
Implants for surgery—Metallic materials—Part 1: Wrought stainless steel
外科植入物 金属材料 第1部分：锻造不锈钢
CurrentMandatoryUpcoming replacement
CurrentMandatory
CurrentMandatory
CurrentMandatory
CurrentMandatory
GB 11567-2017
Motor vehicles and trailers-lateral and rear underrun protection requirements
汽车及挂车侧面和后下部防护要求
CurrentMandatory
CurrentMandatoryUpcoming replacement
CurrentMandatory
GB 18280.1-2015
Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求
CurrentMandatoryUpcoming replacement
GB 16174.1-2015
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商所提供信息的通用要求
CurrentMandatoryUpcoming replacement
GB 18278.1-2015
Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求
CurrentMandatory
GB 18279.1-2015
Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求
CurrentMandatoryUpcoming replacement
CurrentMandatory
CurrentMandatory
CurrentMandatoryUpcoming replacement