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.

3、1 75.2 75.3 .75.4 .75.5 .86 86.1 86.2 86.3 .87 .98 109 .109.1 .109.2 (IQ) 119.3 (OQ) .119.4 (PQ) 129.5 .1310 () 1410.1 1410.2 1410.3 1410.4 .1411 .1512 1512.1 1512.2 .1512.3 ( ) 1512.4 .16 () , , . 17III 254242013 () , .18 () 20 D () , .27 () .30 31IV 254242013 , - . , , , - . , , - , (., 13485), -,

4、 , -. . , , . / -, , ; , . , , - . , - , , , . , , - , - , , , , - - . , ; 556-1. , , , 13485. - , , , . . , , . - , - , , . , :a) / ;b) ;c) , , ;d) ;e) ;f) , ;g) . , , , . , (. 17664), . - /V 254242013 , . , - , . , - . , , - . , . , , ., , , , , , -, , , (IQ), - (OQ) (PQ). , , , , , -. , . , - , .

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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