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生物负载方法学的确认[Hoxey,EU.MedicalDeviceDirectorate,U.K.]原料或产品内部和表面带有的微生物数量称为其生物负载(bioburden)。对生物负载的估算是产品生产包括需灭菌者质量保证计划的一部分。对进行此一估算所...
Confirmation of bioburden methodology [Hoxey, EU. MedicalDeviceDirectorate, U. K. ] The amount of microorganisms present inside and on the surface of a feedstock or product is called its bioburden. Bioburden estimates are part of a product quality assurance program that includes sterilizing products. To make this estimate ...