International Standards for Medical Devices
These ISO/IEC standards apply across multiple regulatory frameworks (EU MDR, FDA, NMPA).
Risk Management
| Standard | Title | Frameworks |
|---|---|---|
| ISO 14971:2019 | Medical devices — Application of risk management | EU MDR, FDA, NMPA |
| ISO 24971:2020 | Guidance on the application of ISO 14971 | EU MDR, FDA |
Software
| Standard | Title | Frameworks |
|---|---|---|
| IEC 62304:2006+AMD1:2015 | Medical device software — Software life cycle processes | EU MDR, FDA, NMPA |
| IEC 82304-1:2016 | Health software — General requirements for safety | EU MDR, FDA |
| IEC 81001-5-1:2021 | Health software and health IT systems safety — Cybersecurity | EU MDR, FDA |
Quality Management
| Standard | Title | Frameworks |
|---|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems | EU MDR, FDA, NMPA |
Biocompatibility
| Standard | Title | Frameworks |
|---|---|---|
| ISO 10993-1:2018 | Biological evaluation — Evaluation and testing within a risk management process | EU MDR, FDA, NMPA |
| ISO 10993-5:2009 | Tests for in vitro cytotoxicity | EU MDR, FDA, NMPA |
| ISO 10993-10:2021 | Tests for skin sensitization | EU MDR, FDA |
| ISO 10993-18:2020 | Chemical characterization of medical device materials | EU MDR, FDA |
Electrical Safety
| Standard | Title | Frameworks |
|---|---|---|
| IEC 60601-1:2005+AMD1:2012+AMD2:2020 | Medical electrical equipment — General requirements | EU MDR, FDA, NMPA |
| IEC 60601-1-2:2014+AMD1:2020 | Medical electrical equipment — EMC requirements | EU MDR, FDA, NMPA |
| IEC 60601-1-6:2010+AMD2:2020 | Medical electrical equipment — Usability | EU MDR, FDA, NMPA |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Medical electrical equipment — Alarm systems | EU MDR, FDA, NMPA |
| IEC 60601-1-9:2007+AMD1:2013 | Medical electrical equipment — Environmentally conscious design | EU MDR, FDA |
| IEC 60601-1-11:2015+AMD1:2020 | Medical electrical equipment — Home healthcare environment | EU MDR, FDA |
| IEC 60601-1-12:2014+AMD1:2020 | Medical electrical equipment — Emergency medical services environment | EU MDR, FDA |
Clinical Investigation
| Standard | Title | Frameworks |
|---|---|---|
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects | EU MDR, FDA |
Usability
| Standard | Title | Frameworks |
|---|---|---|
| IEC 62366-1:2015+AMD1:2020 | Medical devices — Application of usability engineering | EU MDR, FDA, NMPA |
Sterilization
| Standard | Title | Frameworks |
|---|---|---|
| ISO 11135:2014 | Sterilization using ethylene oxide | EU MDR, FDA, NMPA |
| ISO 11137 series | Sterilization using radiation | EU MDR, FDA, NMPA |
| ISO 17665 series | Sterilization using moist heat | EU MDR, FDA, NMPA |
| ISO 11607 series | Packaging for terminally sterilized medical devices | EU MDR, FDA |
INFO
Source files in _shared/standards/.