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Harmonised Standards — Non-active Surgical Implants ​

Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/193

Harmonised Standards List (3 standards) ​

StandardTitle SummaryGSPR ReferenceStatus
EN ISO 14630:2024General requirements (ISO 14630:2024)GSPR 10, 14 (Non-active surgical implants)Current
EN ISO 21535:2024Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2024)GSPR 10, 14 (Non-active surgical implants)Current
EN ISO 21536:2024Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2024)GSPR 10, 14 (Non-active surgical implants)Current

Data Layer Source File ​

eu_mdr/standards/standards-surgical_implants.json

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