Harmonised Standards — Device Processing & Reprocessing

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

Harmonised Standards List (2 standards)

Standard	Title Summary	GSPR Reference	Status
EN ISO 17664-1:2021	Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)	GSPR 11.7 (Device processing)	Current
EN ISO 17664-2:2023	Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)	GSPR 11.7 (Device processing)	Current

Related Pages

• Annex I — GSPR

Data Layer Source File

eu_mdr/standards/standards-processing.json