IVD体外诊断
An IVD, or in vitro diagnostic, is a medical device designed to examine specimens taken from the human body, such as blood, tissue, or saliva, to provide information for diagnosis, monitoring, or treatment decisions. In translation and localization, the term appears in product labels, instructions for use, technical files, performance evaluation reports, and regulatory submissions for diagnostic tests and instruments.
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
IVD translation projects typically include instructions for use, labels, software interfaces, reagent kit inserts, calibrator and control documentation, and technical documentation for regulatory approval. Translators must differentiate between sample types, test principles, result interpretations, and measurement units, because small wording changes can affect how a diagnostic result is read, reported, or acted upon in clinical settings.
Translation checks
A common error is translating IVD analyte names too freely, such as using a general term instead of the exact biomarker or reagent name, which can mislead users and break regulatory traceability. Another risk is confusing 'qualitative' and 'quantitative' result language or altering cutoff wording, changing how clinicians interpret a positive or reactive result.
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 → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
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.