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 |
Compliance is demonstrated via test reports, certificates of conformance, or manufacturer declarations referencing specific standards.
Compliance with the listed standards is the primary route to demonstrating conformity with Essential Principles (TR-001). If a standard is not applicable to your device, provide alternative technical evidence (e.g., technical file, test reports, risk assessment) demonstrating conformity. See TR-002 (Conformity Assessment) for acceptable alternative pathways.