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 |
| Remove the parenthetical note entirely. The table should show: IEC 62366-1:2015+A1:2020 with scope 'Usability engineering — application of usability engineering'. If IEC 60601-1-6 is a recognised standard, add it as a separate row with scope 'Risk management related to usability'. Verify current SFDA recognition of both standards before publishing. | 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 under Medical Devices → Regulations and Guidance → Recognised Standards. Always verify the standard version is current and still recognised by the SFDA at the time of submission — standards are periodically revised, and older versions may no longer be acceptable. If your technical file references a standard that has been superseded, the SFDA will request an update or justification for using the older version.
Further reading
SFDA standard recognition