Harmonised Standards — Non-active Surgical Implants
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/760
Harmonised Standards List (4 standards)
| Standard | Title Summary | GSPR Reference | Status |
|---|---|---|---|
| EN ISO 7197:2024 | Sterile, single-use hydrocephalus shunts and components (ISO 7197:2024) | GSPR 10, 14 (Non-active surgical implants) | Current |
| EN ISO 14630:2024 | General requirements (ISO 14630:2024) | GSPR 10, 14 (Non-active surgical implants) | Current |
| EN ISO 21535:2024 | Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) | GSPR 10, 14 (Non-active surgical implants) | Current |
| EN ISO 21536:2024 | Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023) | GSPR 10, 14 (Non-active surgical implants) | Current |