Chinese Medical Device Standards (GB/YY)
- GB (国家标准) — Mandatory national standards
- YY (医药行业标准) — Industry standards for medical devices
Risk Management
| Standard | Title |
|---|---|
| YY/T 0316-2016 (ISO 14971:2007) | Medical devices — Risk management |
| GB/T 42062-2022 (ISO 14971:2019) | Updated risk management |
Software
| Standard | Title |
|---|---|
| YY/T 0664-2020 (IEC 62304:2006+A1) | Medical device software lifecycle |
Biocompatibility
| Standard | Title |
|---|---|
| GB/T 16886.1-2022 (ISO 10993-1:2018) | Biological evaluation — Part 1 |
| GB/T 16886.5-2017 (ISO 10993-5:2009) | Cytotoxicity tests |
Electrical Safety
| Standard | Title |
|---|---|
| GB 9706.1-2020 (IEC 60601-1:2005+A1) | Medical electrical equipment — General |
| YY 9706.102-2021 (IEC 60601-1-2:2014) | EMC requirements |
Sterilization
| Standard | Title |
|---|---|
| GB 18279.1-2015 (ISO 11135:2014) | EO sterilization |
| GB 18280 series (ISO 11137 series) | Radiation sterilization |
Source