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类别: CLASSIFICATION
II类医疗器械
中等风险医疗器械，在美国通常需要510(k)许可。例如电动轮椅、输液泵和手术铺巾。大多数医疗器械属于此类。
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 II devices present moderate risk and typically need 510(k) in the US (with exemptions). Classification drives testing, clinical expectations, and postmarket burden.
PROCESS / STEPS
- Confirm product code and class.
- Select pathway (often 510(k)).
- Plan performance testing and labeling.
- Maintain QMS and postmarket reporting.
EXAMPLES
- Many infusion pumps and monitoring accessories are Class II.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to II类医疗器械 across 27 authorities in real time.
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