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类别: CLASSIFICATION
I类医疗器械
医疗器械最低风险类别。在美国，大多数I类器械免于510(k)。在欧盟，I类器械可由制造商自行认证（无菌、测量或可重复使用手术器械除外）。
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类医疗器械 across 27 authorities in real time.
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