GOST R ISO 25424-2013 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development validation and routine control of a sterilization process.pdf

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1、 254242013 , ISO 25424:2009Sterilization of medical devices Low temperature steam andformaldehyde Requirements for development, validation and routine control ofa sterilization process for medical devices(IDT) 1 ( ) , 42 383 -3 7 2013 . 73-4 25424:2009 . . , - (ISO 25424:2009 Sterilization of medica

2、ldevices Low temperature steam and formaldehyde Requirements for development, validation androutine control of a sterilization process for medical devices). - 1.5 ( 3.5). - -, A5 1.02012 ( 8). ( 1 ) , -. () . , - - (gost.ru) , 2014 , - - II 2542420131 11.1 .11.2 12 23 24 64.1 64.2 .64.3 64.4 75 .75.

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5、 - ., , - , , , . D .VI 254242013 , Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validationand routine control of a sterilization process for medical devices 201501011 1.1 1.1.1 , (LTSF) . , - , .1.1.2 , - , , -, , (. 14937, 1).1.1.3 , , .1.2 1.2.1 , - , , , , . , .1.2.2 , - . 556-1.1.2.3 (Quality ManagemntSystem), . - , - . (. 13485), , . 14937, , .2.1.2.4 , - , - .1 254242013 1 61010-2-040. 2 -, .1.2.5 , - / . 1 14180. 2 - , - .1.2.6 , , , .

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