Sterility无菌
Sterility is the absence of viable microorganisms on a finished medical device, pharmaceutical product, biologic, or container-closure system that is intended to be free of microbial life and is verified by validated test methods. In translation and localization work, the term appears in test reports, certificate-of-analysis statements, release specifications, regulatory submissions, and labeling where manufacturers state that a product has met validated sterility criteria and remains free from contamination.
Updated
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
The term appears in release documentation, sterilization validation reports, certificates of analysis, and product labels that localization teams translate for global markets. Translators encounter it when working on quality specifications or regulatory dossiers where the distinction between sterile, aseptically processed, and terminally sterilized must be preserved accurately in the target language.
Translation checks
A common error is translating 'sterility' as 'cleanliness' or 'disinfected,' which weakens the regulatory claim and may suggest a lower level of microbial control. Another error is using the same term for both sterility as a state and sterilization as a process; this can distort validation statements or instructions for use.
Chinese document application
Sterility in context · sterility statement
- English source
- Keep the sterile barrier intact until use.
- Chinese rendering to review
- 在使用前保持无菌屏障完整。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Sterile, sterilized and clean describe different statements. Retain the source claim and the object it qualifies. Do not infer a sterility assurance statement from a process description or remove a condition attached to packaging integrity.
Check the returned Chinese file
Inspect the Chinese packaging statement together with its condition of use. Confirm that the barrier, its integrity and the timing restriction remain connected, while any broader sterile claim is retained only where present in the approved source.
Prepare the connected files
Provide the approved label and matching instructions. Confirm the preferred Chinese packaging terminology and return conflicting source wording to the product owner.
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.