Background
There are two kinds of Chinese standards: national (GB) issued by the Standardization Administration of China (SAC), and industrial (YY) issued by NMPA. The non-binding or recommended character has prefix /T. Without /T it means obligatory. In general the version of Chinese standards is at developing stage. Most Chinese standards match the old version of harmonised international standards. There are three categories comparing international standards: identical (IDT), equivalent (EQV), or non-equivalent (NEQ).
So far there are so far 227 GB standards (93 obligatory and 134 recommended) and 1564 YY standards (303 obligatory and 1261 recommended).
In July, 2022 there is a new issued template essential principle of Safety and Performance of medical device in which the BASIC standards are listed. Paired to Chinese requirements and standards, the reference documents in defined TOC-chapter should be addressed in EP-list.
Meaning of Chinese standards
The standards depending binding or not binding is a regulation scale to establish quality management and development the medical device.
Standards are important parts in China to create design input, prepare product technical requirements prior to testing, and execute testing in product life cycle. Often the Chinese standard is mentioned in product specific guidance.
Unfortunately there is no year of standards in EP shown, we list not only the full standards but also corresponding international standards below.
GB Standard
GB 15213-2016 医用电子加速器 性能和试验方法
Medical electron accelerators—Functional performance characteristics and test methods
GB 16174.1-2015 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
GB 16174.2-2015手术植入物 有源植入式医疗器械 第2部分: 心脏起搏器
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-2:2005 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers
GB 18278.1-2015 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
GB 18279.1-2015 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
GB 18280 .1 and .2 医疗保健产品灭菌 辐射
ISO 17665-1:2006 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007 Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices
ISO 11137-2:2006 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
GB 4793.1-2007 测量、控制和实验室用电气设备安全通用要求
GB 4793.6-2008 测量、控制和实验室用电气设备的安全要求
IEC 61010-1:2001 Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements
IEC 61110-2-0-10:2005 Safety requirements for electrical for measurement, control, and laboratory use -- Part 6: Particular requirements for laboratory equipment for the heating of materials
GB 9706.102-2021 (YY 0505-2012)
IEC 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic compatibility -- Requirements and tests
GB 9706.1-2020 医用电气设备 第1部分：基本安全和基本性能的通用要求
IEC 60601-1:2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
GB 9706.15-2008 医用电气设备 第1-1部分：通用安全要求 并列标准：医用电气系统安全要求
IEC 60601-1-1.2000 Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
GB 9706.16-2015 医用电气设备 第2部分：放射治疗模拟机安全专用要求
IEC 60601-2-29:2008 Medical electrical equipment—Part 2: Particular requirements for the safety of radiotherapy simulators
GB 9706.212-2020 医用电气设备 第2-12部分：重症护理呼吸机的基本安全和基本性能专用要求
GB 9706.213-2021 医用电气设备 第2-13部分：麻醉工作站的基本安全和基本性能专用要求
ISO 80601-2-12:2011 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13:2011 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation
GB 9706.28-2006 医用电气设备 第2部分: 呼吸机安全专用要求 治疗呼吸机
IEC 60601-2-12:2001 Medical electrical equipment―Part 2: Particular requirements for the safety of lung ventilators―Critical care ventilators
GB/T Standard
GB/T 14233.1-2008 医用输液、输血、注射器具检验方法 第1部分：化学分析方法
GB/T 14233.2-2005 医用输液、输血、注射器具检验方法 第2部分：生物学试验方法
ISO 10993-4/5/6/10/11/12:2002 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods and Part 2: Biological test methods
GB/T 14710-2009 医用电器环境要求及试验方法
The environmental requirement and test methods for medical electrical equipment
GB/T 16886.16-2021 医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计
GB/T 16886.17-2005 医疗器械生物学评价 第17部分：可沥滤物允许限量的建立
GB/T 16886.18-2011医疗器械生物学评价 第18部分：材料化学表征
ISO 10993-16:2017 Biological evaluation of medical devices—Part 16: Toxico*kinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
GB/T 1809:2021 医用增材制造 粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法
Additive Manufacturing for Medical Applications: Verification Methods of Cleaning and Cleaning Effectiveness of Metal Powder Used in Powder-bed Fusion Process
GB/T 18268.1:2010 测量、控制和实验室用的电设备 电磁兼容性要求 第1部分：通用要求
GB/T 18268.26:2010 测量、控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断（IVD）医疗设备
IEC 61326-1:2020 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 1:General requirements
EC 61326-2-6:2005 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
GB/T 19974-2018 医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
ISO 14937:2009 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 20438.1-2017 电气/电子/可编程电子安全相关系统的功能安全 第1部分：一般要求
GB/T 20438 series
IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems—Part 1:General requirements
GB/T 20918-2007 信息技术 软件生存周期过程 风险管理
Information technology—Software life cycle processes—Risk management
GB/T 4857.1-1992 包装 运输包装件基本试验 第1部分：试验时各部位的标示方法
ISO 2206:1987 Packaging—Basic tests for transport packages—Part 1:Identification of parts when testing
YY standard
YY 0709-2009 医用电气设备 第1-8部分：安全通用要求 并列标准：通用要求 医用电气设备和医用电气系统中报警系统的测试和指南
IEC 60601-1-8:2003 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY 1298-2016 医用内窥镜胶囊式内窥镜
Medical endoscope capsule endoscope
YY 9706.102-2021 医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验
IEC 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic compatibility -- Requirements and tests
YY 9706.108-2021 医用电气设备 第1-8部分：基本安全和基本性能的通用要求 并列标准：通用要求,医用电气设备和医用电气系统中报警系统的测试和指南
IEC 60601-1-8:2006+A1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY 9706.247-2021 医用电气设备 第2-47部分：动态心电图系统的基本安全和基本性能专用要求
IEC 60601-2-47:2012 Medical electrical equipment Part 2-47: Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems
YY/T 0316-2016 医疗器械 风险管理对医疗器械的应用
ISO 14971:2007 Medical devices Application of risk management to medical devices
YY/T standard
YY/T 0316-2016 医疗器械 风险管理对医疗器械的应用
ISO 14971:2007 Medical devices Application of risk management to medical devices
YY/T 0345.1-2011 外科植入物 金属骨针 第1部分：材料和力学性能要求
ISO 5838-1:1995 Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements
YY/T 0681.12009 无菌医疗器械包装试验方法 第1部分：加速老化试验指南
Y/T 0681 series
ASTM F 1980:02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Series of Test methods for sterile medical device Package
YY/T 0758-2021 治疗用激光光纤通用要求
General requirements for medical laser fiber
YY/T 0771.1 to .4-2020 动物源医疗器械 第1部分:风险管理应用
Series of medical devices utilizing animal tissues and their derivatives
YY/T 0809.4-2018 外科植入物 部分和全髋关节假体 第4部分：带柄股骨部件疲劳性能试验和性能要求
ISO 7206-4:2010 Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components
YY/T 1276-2016 医疗器械干热灭菌过程的开发、确认和常规控制要求
ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
YY/T 1463-2016 医疗器械灭菌确认 选择微生物挑战和染菌部位的指南
Medical Device Sterilization Validation Guidelines for Selecting Microbial Challenge and Contamination Sites
YY/T 1464-2016 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求
ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
YY/T 1550.2-2019 一次性使用输液器具与药物相容性研究指南 第2部分：可沥滤物研究 已知物
Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable Known substance
YY/T 1730-2020 一次性使用血液透析导管
Hemodialysis catheter for single use
YY/T 1809-2021 医用增材制造 粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法
Additive Manufacturing for Medical Applications: Verification Methods of Cleaning and Cleaning Effectiveness of Metal Powder Used in Powder-bed Fusion Process
YY/T 9706.106-2021 医用电气设备 第1-6部分：基本安全和基本性能的通用要求 并列标准：可用性
IEC 60601-1-6:2010/AMD1:2013 Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
QM standards
GB 50457-2019 医药工业洁净厂房设计标准
Safety requirements for electrical for measurement, control, and laboratory use -- Part 6: Particular requirements for laboratory equipment for the heating of materials
YY 0033:2000 无菌医疗器具生产管理规范
Standard for the production management of sterile medical devices
YY/T 0287:2017 医疗器械 质量管理体系 用于法规的要求
ISO 13485:2016 Quality management systems
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We have a full templates of new essential principle of Safety and Performance of medical device. We guide you to search applicable Chinese standards to your product group and justification if not.
Do you know that you have list Chinese standards in submission dossier, follow standards in Chinese local testing and provide test report in TD chapter 3 non-clinical verification?
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Comparison to IMDRF and EU (GSPR)
