医疗器械软件和软件特定风险的表征考虑-中英文
27 January 2025
Final Document
IMDRF/SaMD WG/N81 FINAL: 2025
Characterization
Considerations for Medical
Device Software and Software-
Specific Risk
AUTHORING GROUP
IMDRF Software as a Medical Device Working Group
27 2025年1月
最终文档
IMDRF /SaMD WG/N81最终版：2025
医疗器械软件和软件特定风险的
表征考虑
创作团队
IMDRF 软件作为医疗器械工作组
IMDRF/SaMD WG/N81 FINAL: 2025
2
Preface
© Copyright 2024 by the International Medical Device Regulators Forum.
This work is copyright. Subject to these Terms and Conditions, you may download,
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include the following acknowledgement (delete inapplicable):
“[Translated or adapted] from [insert name of publication], [year of publication],
International Medical Device Regulators Forum, used with the permission of the
International Medical Device Regulators Forum. The International Medical Device
Regulators Forum is not responsible for the content or accuracy of this
[adaption/translation].”
All other rights are reserved and you are not allowed to reproduce the whole or any part
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rights are to be sent to the IMDRF Secretariat.
Incorporation of this document, in part or in whole, into another document, or its
translation into languages other than English, does not convey or represent an
endorsement of any kind by the IMDRF.
Naoyuki YASUDA, IMDRF Chair
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