Biocompatibility生物相容性
Biocompatibility describes how a medical device material interacts with living tissue and whether that interaction can produce local, systemic, or delayed adverse effects. In device development and regulatory translation, it appears in biological evaluation plans and reports, risk-management files, and technical documentation that support market authorization, where the scope of testing and the conclusions must be communicated clearly and consistently.
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
Biocompatibility appears in biological evaluation reports, risk-management files, IFUs, and technical documentation for EU and U.S. submissions. Translators must handle terms such as cytotoxicity, sensitization, irritation, and genotoxicity without introducing clinical claims or softening test limitations; terminology consistency across study reports, labels, and justification documents is critical for reviewers and notified bodies.
Translation checks
A frequent mistake is translating 'biocompatible' as an absolute guarantee of safety, when in fact testing only supports compatibility under defined conditions. Overstating biocompatibility may create a false safety claim in labeling or technical documentation, and reviewers may challenge the conclusion if the test scope is not accurately translated in the biological evaluation.
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.