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類別: DOCUMENTATION
器材歷史記錄(DHR)
包含成品醫療器材完整生產歷史的記錄彙編，包括生產日期、數量、驗收記錄和標籤。FDA 21 CFR 820.184要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
The Device History Record (DHR) documents the production history of a finished device or lot—showing that the device was manufactured in accordance with the Device Master Record (DMR).
PROCESS / STEPS
- Capture lot/serial numbers, manufacturing dates, quantity released, and acceptance records per DMR.
- Record deviations, rework, and disposition decisions with approvals.
- Retain DHR for the required retention period tied to device life and regulation.
- Make DHR available for FDA inspection and complaint investigations.
EXAMPLES
- A sterile implant lot DHR includes sterilization cycle records, bioburden results, packaging integrity checks, and final release signatures.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 器材歷史記錄(DHR) across 27 authorities in real time.
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