GOST ISO 11607-2011 Packaging for terminally sterilized medical devices General requirements《终端无菌医学设备的包装 第1部分 通用要求》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) , - (ISO 11607:1997, IDT) 2013 ISO 11607 2011 ISO 116072011 II , 1.092 -. 1.22009 -. , . , , , 1 - () 2 - () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ 4 13 2011 . 1397- ISO 116072011 1 2013 .

2、5 ISO 11607:1997 Packaging for terminally sterilized medical devices ( , ) (IDT). - . 116072003 6 ( ) . - , - . - - . ISO 116072011 III C, 2013 - , . ISO 116072011 IV - . - , , , , . - EN 868 ( ). -, - -. -, , - , - . - , - . , , ( ), , . - , . - , . ISO 116072011 1 , Packaging for terminally steril

3、ized medical devices. General requirements 2013-01-01 1 1.1 1.1.1 - , - , , -, (. 4). 1.1.2 - , ( 5). -, , , - . , - , . , - ( 6), - , - , - , - - . ISO 116072011 21.2 1.2.1 , , - , . 1.2.2 - . . 2 : ISO 186:1994 Paper and board. Sampling to determine average quality ( . ) ISO 2859-1:1989 Sampling p

4、rocedures for inspection by attributes Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection (- . 1. - (AQL) - ) ISO 5636-1:1984 Paper and board Determination of air permeance (medium range) Part 1: General method ( . - ( ). 1. ) ISO 9001:2000 Quality management

5、systems. Requirements ( - . ) ISO 11140-1:1995 Sterilization of health care products. Chemical indicators. Part 1. General requirements ( . -. 1. ) 3 - : 3.1 (closure): () - , , () - . ISO 116072011 33.2 (closure integrity): , - , . 3.3 (compliance qualification): - , - , . 3.4 (development): - - .

6、3.5 (failure): , . 3.6 (failure analysis): , - . 3.7 ( ) (final package): - , ( ), (. . , - ). 3.8 (manufacturer): (- ), / - . 3.9 (medical device): , , -, , , , : - , , , -; - , , , ; - , ; - , , - ISO 116072011 4 , - . 3.10 (microbial barrier): . 3.11 (labeling system): , . 3.12 (packaging compati

7、bility): / , - 3.13 (package integrity): - . 3.14 (performance qualification): - - () , -. 3.15 (producer): , (- ), - / . 3.16 / (product): / - . 3.17 (qualification): , . 3.18 (revalidation): . 3.19 (seal): , . 3.20 (seal integrity): - , , . 3.21 (seal strength): . ISO 116072011 53.22 (sterile flui

8、d path packaging): , , . 3.23 (sterilization compatibility): - / , - . 3.24 (user): (- ), . 3.25 (validation): -, , , . , , : ; , , ( ), -, - ( ). 3.26 (terminally sterilizer): - , , . 4 4.1 4.1.1 , , . ISO 9001. . ISO 116072011 64.1.2 , -, -, , (AQL) ISO 2859-1 ISO 186 (SPC). . 4.1.3 4.1.3.1 - -, , . 4.1.3.2