类别: STANDARDS

ISO 10993 (生物相容性)

评估医疗器械生物安全性的系列标准。ISO 10993涵盖细胞毒性、致敏性、刺激性、全身毒性、遗传毒性、植入效应和血液相容性测试。

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

ISO 10993 is the series of standards for biological evaluation of medical devices, covering cytotoxicity, sensitization, irritation, systemic toxicity, and more.

PROCESS / STEPS

Map device contact category to endpoints.
Perform chemical characterization as appropriate.
Execute or justify biological tests.
Document in biological evaluation report linked to risk management.

EXAMPLES

ISO 10993-1 provides the framework; other parts detail specific tests.

RELATED GUIDES & TOOLS

SOURCES

ISO 10993-1 ↗

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