
Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose For Small Or Infrequent Production Batches
出版:Nederlands Normalisatie Instituut

专家解读视频
Defines a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1000 colony-forming units (cfu) that are manufactured in small quantities (less than 1000 product units).
ISO/TS 13409:2002 - Identical