Chinese Medical Device Standards (GB/YY)
China's medical device standards are published by SAC (Standardization Administration of China) and NMPA:
- GB — Mandatory national standards
- YY — Industry standards for medical devices
- YY/T — Recommended industry standards
Source
openstd.samr.gov.cn — Official standards database
Risk Management
| Standard | International Equivalent | Title |
|---|---|---|
| YY/T 0316-2016 | ISO 14971:2007 | Medical devices — Application of risk management |
| GB/T 42062-2022 | ISO 14971:2019 | Medical devices — Application of risk management (updated) |
| YY/T 1437-2016 | ISO 24971:2013 | Guidance on the application of risk management |
Software
| Standard | International Equivalent | Title |
|---|---|---|
| YY/T 0664-2020 | IEC 62304:2006+A1 | Medical device software — Software life cycle processes |
| YY/T 1579-2018 | IEC 82304-1:2016 | Health software — General requirements for safety |
Biocompatibility
| Standard | International Equivalent | Title |
|---|---|---|
| GB/T 16886.1-2022 | ISO 10993-1:2018 | Biological evaluation — Part 1: Evaluation and testing |
| GB/T 16886.5-2017 | ISO 10993-5:2009 | Biological evaluation — Part 5: Cytotoxicity tests |
| GB/T 16886.10-2017 | ISO 10993-10:2013 | Biological evaluation — Part 10: Sensitization tests |
| GB/T 16886.18-2011 | ISO 10993-18:2005 | Biological evaluation — Part 18: Chemical characterization |
Electrical Safety
| Standard | International Equivalent | Title |
|---|---|---|
| GB 9706.1-2020 | IEC 60601-1:2005+A1:2012 | Medical electrical equipment — General requirements |
| YY 9706.102-2021 | IEC 60601-1-2:2014+AMD1:2020 | Medical electrical equipment — EMC requirements |
| YY 9706.106-2021 | IEC 60601-1-6:2010+AMD2:2020 | Medical electrical equipment — Usability |
| YY 9706.108-2021 | IEC 60601-1-8:2006+AMD2:2020 | Medical electrical equipment — Alarm systems |
Quality Management
| Standard | International Equivalent | Title |
|---|---|---|
| YY/T 0287-2017 | ISO 13485:2016 | Medical devices — Quality management systems |
Usability
| Standard | International Equivalent | Title |
|---|---|---|
| YY/T 1474-2016 | IEC 62366-1:2015 | Medical devices — Application of usability engineering |
Clinical Evaluation
| Standard | International Equivalent | Title |
|---|---|---|
| YY/T 1437-2016 | ISO 14155:2011 | Clinical investigation of medical devices |
| GB/T 42061-2022 | ISO 13485:2016 | QMS for regulatory purposes |
Sterilization
| Standard | International Equivalent | Title |
|---|---|---|
| GB 18279.1-2015 | ISO 11135:2014 | EO sterilization |
| GB 18280 series | ISO 11137 series | Radiation sterilization |
| GB 8599-2008 | ISO 17665-1:2006 | Moist heat sterilization |