GOST ISO 8638-2012 Extracorporeal blood circuit for haemodialysers haemodiafilters and haemoconcentrators Technical requirements and test methods《血液透析器、血液过滤器及血液浓缩器的体外血液循环器 技术要求和试验方.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARTIZATION, METROLOGY AND CERTIFICATION (ISC) , (ISO 8638:1989, IDT) 2013 ISO 8638 2012 ISO 86382012 II , - 1.092 . - 1.22009 . , -. , , , 1 - - - () 2 () 3 , - ( 41-2012 24 2012 .) : - ( 3166) 004-97 ( 3166) 004-97 AZ AM BY KZ KG MD - RU TJ UZ UA 4 19 2012 . 1926-

2、ISO 86382012 1 2015 . ISO 86382012 III5 ISO 8638:1989 Extra-corporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators ( , -). (IDT). - . 863899 6 ( ) - . - , -. - C, 2013 - , ISO 86382012 V ( ), , -. - . , , , , . - , , , , -, . , - . - - , , - . . - , . ISO 86382012 1 -, Extra

3、corporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators. Technical requirements and test methods 2015-01-01 1 - ( ), - , . , , , - . . , . , , -, , , - , - , . , - ISO 8637. . 2 : ISO 86382012 2 ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators (-, ). ISO 472:

4、1979 Plastics. Vocabulary Bilingual edition (. .) ISO 594-2:1991 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Part 2. Lock fittings ( 6% () , . 2. -) ISO 7000:1989 Graphical symbols for use on equipment. Index and synopsis (- , . ) 3 -: 3.1 : - ,

5、 , . 3.2 : , . 3.3 : , - - . 3.4 : - . 3.5 : , , - . 4 4.1 . - . 5.1. ISO 86382012 34.2 . - , , - - . 5.2. 4.3 . - 5.3. 4.4 . . 5.4. 4.5 , , - -, , . . 5.5. 4.6 4.6.1 : - , - 1,5 , ; - - 200 . . 24 . 5.6.1. ISO 86382012 4 4.6.2 , - , , , - 13. 5.6.2. 1 , - , - 2 , 4.6.3 - 6 %. - ISO 594-2. 5.6.3. 4.

6、6.4 , , -, 6 % (). 5.6.4. 4.6.5 , , 0,8 ( 21). , - , . ISO 86382012 5 5.6.5. 4.6.6 - , . - 100 . 5.6.6. 4.7 4.7.1 20 %. 5.7.1. 4.7.2 5 %. 5.7.2. 3 6 %- - , ISO 86382012 6 5 5.1 , 4.1, . 5.2 - , , , -. , , . 5.3 . 5.4 , . 5.5 - , - . 5.6 5.6.1 . 5.6.1.1 , . (4.6.1). 5.6.1.2 5.6.1.2.1 (60 5) /. ISO 86382012 75.6.1.2.2 . 5.6.1.3 5.6.1.3.1 , . - , - , . 5.6.1.3.2