GB/T 29791.5-2013
ActiveIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting
体外诊断医疗器械 制造商提供的信息（标示） 第5部分：自测用体外诊断仪器
Application Summary AI generated
This standard specifies the labeling requirements for in vitro diagnostic instruments intended for self-testing by laypersons outside of clinical laboratory settings. It is applied by manufacturers to ensure that instructions, symbols, and safety information on such devices (e.g., home blood glucose meters or pregnancy test readers) are clear and usable for non-professional users. The standard supports regulatory compliance and user safety in home healthcare and over-the-counter diagnostic product contexts.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.