← 所有術語
類別: CLASSIFICATION
I類醫療器材
醫療器材最低風險類別。在美國，大多數I類器材免於510(k)。在歐盟，I類器材可由製造商自行認證（無菌、測量或可重複使用手術器材除外）。
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
Class I devices are lowest risk. Many US Class I devices are 510(k)-exempt; EU Class I may be self-declared except sterile/measuring/reusable surgical variants needing NB involvement.
PROCESS / STEPS
- Confirm classification and exemptions.
- Implement proportionate QMS and labeling.
- Register/list as required (US establishment registration/device listing).
- Monitor postmarket complaints even for low-risk devices.
EXAMPLES
- Elastic bandages and many manual instruments are typical Class I examples (check current product codes).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to I類醫療器材 across 27 authorities in real time.
START FREE →