GOST R ISO 13408-5-2011 Aseptic processing of health care products Part 5 Sterilization in place《保健品无菌加工 第5部分 原位灭菌》.pdf

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1、 13408-52011 5 ISO 13408-5:2006Aseptic processing of health care products Part 5: Sterilization in place(IDT) 27 2002 . 184- , 1.02004 . 1 () , 42 458 - 3 7 2011 . 731-4 13408-5:2006 . 5. (ISO 13408-5:2006 Asepticprocessing of health care products Part 5: Sterilization in place). - , - 5 , - . - ()

2、. , , 2012 , - - II 13408-520111 12 13 24 34.1 .34.2 34.3 .34.4 - 35 .35.1 .35.2 45.3 .46 56.1 .56.2 56.3 .57 (SIP ) .67.1 .67.2 .68 .68.1 .68.2 () .68.3 .68.4 78.5 78.6 88.7 99 .99.1 99.2 99.3 99.4 .99.5 .910 .10 () 11 () 13 14III 13408-52011 13408 - : , , -, . , - , , . ( 13408-4). , - . , . 13408

3、 / 198 :- 1. ;- 2. ;- 3. ;- 4. ;- 5. ;- 6. .IV 13408-52011 5 Aseptic processing of health care products. Part 5. Sterilization in place 201212011 1.1 (SIP) - , - , , , . - . , - , .1.2 , , .1.3 , .1.4 , (GMP).1.5 , - , - , . . 22442-1, 22442-2 22442-3.2 : 11138 ( ) . ISO 11138 (all parts) Sterilizat

4、ion of health care products Biological indicators 11140 ( ) . (ISO 11140 (all parts) Sterilization of health care products Chemical indicators) 13408-12000 . 1. - (ISO 3408-1 Aseptic processing of health care products Part 1: General requirements) 13408-4 . 4. (ISO 13408-4 Aseptic processing of heal

5、th care products Part 4: Clean-in-place technologies) 14161 . . , (ISO 14161 Sterilization of health careproducts Biological indicators Guidance for the selection, use and interpretation of results) 14937 . - , - (ISO 14937 Sterilization of health care products General requirements1 13408-52011 for

6、characterization of a sterilizing agent and the development, validation and routine control of a sterilizationprocess for medical devices) 17665-1 . . 1. , (ISO 17665-1 Sterilization of health care products Moist heat Part 1: Requirements for the development,validation and routine control of a steri

7、lization process for medical devices)/ 90003 . 9001:2000 (ISO/IEC 90003 Softwareengineering Guidelines for the application of ISO 9001:2000 to computer software)3 13408-1, :3.1 (dead leg): , .3.2 () (design qualification): - , , - ./ 11139:2006, 2.123.3 (material safety data sheet): -, - ./ 11139:20

8、06, 2.323.4 (process parameter): . ./T 11139:2006, 2.343.5 (process variable): , - . , , , , , ./ 11139:2006, 2.353.6 (sterilization in place SIP): - . 13408-1 ( 19) SIP. SIP , . SIP .3.7 (sterility assurance level-SAL): . 1 SAL , 106 103. 106 , 103./ 11139:2006, 2.46 2 , - , (SIP).3.8 (sterilizatio

9、n process): , ./T 11139:2006, 2.493.9 (sterilizing agent): , - ./ 11139, 2.502 13408-520114 4.1 4.1.1 13408-1.4.1.2 () , .4.1.3 , , .4.1.4 , , - .4.2 4.2.1 , () - / .4.2.2 , , .4.3 () , , - , , -. .4.4 - 4.4.1 () - - .4.4.2 - , .5 5.1 5.1.1 , , :) -;b) , ;) , , -;d) / ;) ;f) ;g) , ( -);h) ;i) , , ;j) .5.1.2 , - .5.1.3 , - .5.1.4 , (SIP), - . , 3 13408-52011 , .5.1.5 . . -