Recognised Consensus Standards
Why consensus standards matter
Demonstrating compliance with a recognised consensus standard is the primary method for showing conformity with the SFDA's Essential Principles of Safety and Performance. Where a device is designed and tested in accordance with a recognised standard, the SFDA accepts this as strong evidence of compliance with the corresponding Essential Principle — without requiring bespoke justification.
SFDA standard recognition
The SFDA recognises standards issued by major international standards bodies, including:
- ISO (International Organization for Standardization)
- IEC (International Electrotechnical Commission)
- ASTM International
- CEN (European Committee for Standardization — where adopted internationally)
The SFDA also accepts Saudi GSO standards (Gulf Standards Organisation) where equivalent to international standards.
Key standards by topic area
Quality management
| Standard | Scope |
|---|
| ISO 13485:2016 | Quality management systems for medical devices |
| ISO 9001:2015 | General quality management (supplementary only) |
Risk management
| Standard | Scope |
|---|
| ISO 14971:2019 | Risk management for medical devices |
| ISO/TR 24971:2020 | Guidance on the application of ISO 14971 |
Biocompatibility
| Standard | Scope |
|---|
| ISO 10993 series | Biological evaluation of medical devices (multiple parts) |
| ISO 10993-1:2018 | Evaluation and testing within a risk management framework |
Electrical safety and electromagnetic compatibility (EMC)
| Standard | Scope |
|---|
| IEC 60601-1:2005+A1+A2 | General requirements for basic safety and essential performance |
| IEC 60601-1-2:2014+A1 | EMC requirements |
| IEC 60601-1-6:2010+A1+A2 | Usability |
Software and IEC 62304
| Standard | Scope |
|---|
| IEC 62304:2006+A1:2015 | Software lifecycle processes for medical device software |
| IEC 62366-1:2015+A1:2020 | Usability engineering — application of usability engineering |
Sterility
| Standard | Scope |
|---|
| ISO 11135:2014 | Sterilisation of health-care products — EO sterilisation |
| ISO 11137 series | Radiation sterilisation |
| ISO 17665-1:2006 | Steam sterilisation |
| ISO 11607 series | Packaging for terminally sterilised medical devices |
IVD-specific
| Standard | Scope |
|---|
| ISO 18113 series | IVD — information supplied by the manufacturer |
| ISO 15189:2022 | Medical laboratories — requirements for quality and competence |
Clinical evaluation
| Standard | Scope |
|---|
| ISO 14155:2020 | Clinical investigation of medical devices |
How to reference standards in the technical file
In the Essential Principles compliance section of the technical file, for each applicable principle:
- State the principle
- Identify the applicable standard(s)
- Reference the specific standard version tested against
- Reference the test report or certificate demonstrating compliance
Checking for current recognised standards
The SFDA publishes its list of recognised standards on the SFDA website. Always verify the standard version is current and still recognised by the SFDA at the time of submission — standards are periodically revised.
Further reading