GB/T 45351-2025
UpcomingManufacture of cell-based medical devices—Control of microbial risks during processing
基于细胞的医疗器械生产 加工过程中微生物风险控制
Application Summary AI generated
This standard specifies requirements for controlling microbial contamination during the manufacturing of cell-based medical devices, such as tissue-engineered products or cell therapies. It applies to production facilities and processes where living cells are handled, including steps like cell isolation, culture, and final product filling. The standard is used to ensure sterility and safety in the healthcare industry, particularly for products intended for implantation or direct patient application.
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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.