IFU使用说明
Instructions for Use (IFU) is a controlled document that explains how to operate, maintain, and dispose of a medical device or in vitro diagnostic safely and effectively. In regulatory and labeling workflows, it is treated as mandatory labeling content that must be translated, localized, and verified to meet each market's language, format, and readability expectations before the product can be placed on the market.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
IFU appears in labeling translation projects for medical devices and IVDs, often alongside labels, packaging, and quick-start guides. Translators receive source files from regulatory or technical publications teams and work with in-country reviewers to adapt terminology, units, symbols, and warnings before the document is approved for commercial release in each target country.
Translation checks
A frequent mistake is translating IFU text as generic technical prose without preserving warning hierarchy or using unapproved terminology from the product's glossary. This can create usability errors or regulatory findings because a warning that is softened, reordered, or mistranslated may no longer communicate the residual risk accurately to the intended user.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.