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.