GB/T 29791.3-2013
ActiveIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
体外诊断医疗器械 制造商提供的信息（标示） 第3部分：专业用体外诊断仪器
Application Summary AI generated
This standard specifies the content and format of information that manufacturers must provide with in vitro diagnostic instruments intended for professional use, such as labeling, instructions for use, and technical documentation. It applies to diagnostic instruments used in clinical laboratories, hospitals, and other healthcare settings by trained professionals, ensuring that critical safety, performance, and operational details are clearly communicated. The standard supports regulatory compliance and safe, effective use of these devices in medical diagnostics.
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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.