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AAMI TIR27 Ed. 1 (2001)被替代
Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose - Method Vd Max
出版：Association for Advancement of Medical Instrumentation
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標(biāo)準(zhǔn)編號(hào)： AAMI TIR27 Ed. 1 (2001)
發(fā)布時(shí)間：2001/10/9 0:00:00
標(biāo)準(zhǔn)類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標(biāo)準(zhǔn)頁(yè)數(shù)：15
標(biāo)準(zhǔn)簡(jiǎn)介
Defines a method of substantiation of 25 kGy as the sterilization dose for radiation sterilization of health care products with an average bioburden for the entire product unit (SIP=1) < 1000 colony-forming units (cfu). Application of the method of substantiation of 25 kGy described in this technical report may be used to meet the requirements specified under subclause 6.2.2 relating to product qualification in ISO 11137.
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ISO 11137:1995 - Identical
