Recognised International Standards
Compliance with internationally recognised standards is the primary route to demonstrating conformity with Essential Principles (TR-001).
| Standard | Scope |
|---|---|
| ISO 13485:2016 | Quality management systems |
| ISO 14971:2019 | Risk management |
| IEC 62304:2006/Amd 1:2015 | Software lifecycle |
| IEC 62366-1:2015 | Usability engineering |
| ISO 10993 series | Biological evaluation |
| ISO 11135/11137/17665 | Sterilisation |
| IEC 60601-1 | Medical electrical equipment — general safety |
| IEC 60601-1-2 | Electromagnetic compatibility |
How to Demonstrate Compliance
Compliance with listed standards is demonstrated via:
- Test reports (independent or in-house, with documented methodology)
- Certificates of conformance (from accredited labs or manufacturers)
- Manufacturer declarations of conformity referencing specific standards
If a Standard Is Not Applicable
If a standard does not apply to your device, provide alternative technical evidence such as:
- Technical file documenting design and performance
- Risk assessment per ISO 14971
- Literature review or published clinical data
- Engineering drawings with tolerance justification
See TR-002 (Conformity Assessment) for class-specific pathways and acceptable evidence combinations.