Chinese standards listed in essential principle of Safety and Performance of medical device in 2022



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: Toxicokinetic 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

Service of EP, standards and translation

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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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Example of guidlines

1. Guidelines for the biological evaluation and review of medical devices

2. Guidelines for the writing of registration and application materials for drug-containing medical device products

3. Guidelines for the division of medical device registration units

4. Guidelines for the technical review of mobile medical device registration

5. Guidelines for the technical review of the registration of animal-derived medical devices

6. Guidelines for the design of clinical trials of medical devices

7. Accept the technical guidelines for overseas clinical trial data of medical devices

8. Guidelines for the registration and review of medical devices for the prevention and treatment of rare diseases

9. Guidelines for the technical review of the registration of the service life of active medical devices

10. Guidelines for the technical review of the registration of medical devices for personalized additive manufacturing of passive implantable bones, joints and oral hard tissues

Examples of standards

1. YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Sterilization packaging materials Requirements and test methods

2. YY/T 0681.12-2022 Test methods for sterile medical device packaging Part 12: Rubbing resistance of soft barrier materials

3. YY/T 1812-2022 Characterization of physical and chemical properties of degradable biomedical metal materials

4. YY/T 1813-2022 Medical Electrical Equipment Use Reliability Information Collection and Evaluation Method

5. YY/T 1815-2022 Medical Device Biological Evaluation Application of Toxicological Concern Threshold (TTC) to Evaluate the Biocompatibility of Medical Device Components

6. YY/T 1837-2022 Medical Electrical Equipment General Requirements for Reliability

7. YY/T 1843-2022 Basic Requirements for Network Security of Medical Electrical Equipment

8. YY/T 1833.1-2022 Artificial intelligence medical devices - Quality requirements and evaluation - Part 1: Terminology

9. YY/T 1833.2-2022 Artificial intelligence medical devices - Quality requirements and evaluation - Part 2: General requirements for data sets

10 YY/T 0567.6-2022 Aseptic processing of healthcare products - Part 6: Isolator syystem