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Contents
1.2. Co
3. 15
4. 11 2
5. J I 17 3
6. 3
7. O 1 ail 1 JIS T 14971 JIS 14971 3 4
8. 2
9. 17 169 3
10. JIS T 3250 6 JIS T 14971 17 0216002 2 1
11. 14 96 2 14 1 19 2 1 17 2 16 0216002 el
12. 10
13. 3
14. 16 169 16 169 5
15. 8 JIS i T 14971 169
16. 1 2 5 2 1 G 2 5 1 1
17. 4 5 T 3250 4 4 6 T 3250 4 1 7 T 3250 4 5 8 T 3250
18. 2 2 1 JIS T 3250 2 2 ISO 8637 2004 Cardiovascular implants and artificial organs Haemodialysers haemodiafilters haemofilters and haemoconcentrators 2 3 JIS T 0993 1 1 2 4 ISO 10993 4 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood 5 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 6 15S0 10993 11 Biological evaluation of medical devices Part 11 Tests for systemic toxicity 7 ISO 594 2 Conica1 fittings with 6 Lure taper for syringes needles and certain other medical equipment Part 2 Lock fittings 8 JIS T 0307
19. RE 16
20. 1 09 JIS T 14971
21. a 1 2 3 B 2
22. 5 6 7 B 13
23. JIS T 14971 pn JIS T 3250 4 4 4 4 3 4 4 4 5 JIS T 3250 9 6 17 3 10 0310003
24. 1 JIS T 14971 JIS T 14971 JIS T 3250 4 4 4 4 1 4 4 2 UIS T 14971 UIS T 14971
25. ME 4 1 JIS T 0993 1 1 JIS T 14971 JIS T 3250 4 1 JIS T 0993 1 1 JIS T 14971 JIS T 3250 4 4 4 4 1 1 4 4 2 2 UIS T 14971
26. 1 1 1 2 MGM 2 2 17 2 16 0216002 3 g
27. 59 5 1 5 15 1 3 JIS T 3250 1 JIS T 3250 4 5 3 UFR mL hr mmHg 25 JIS T 3250 4 5 1 6B1 109 1596 8 20
28. 1 1 1 3 i 4 2 Oo 5 1 1
29. a tr eb 3 4 JIS T 3250 4 1
30. EUC 1 14 3
31. 9 15 2 13 0213001 a 10 17 3 30 0330001 GMP QMS 4 4 11 10 3 31 353 RN 3 T 3250 3 1 blood compartment MD MN MM mM hm
32. a 2 17 3 31 0331012 58 6 20 494 1 5 V 4 58 6 20 401 oO 1 1
33. 2 JIS T 3250 4 5 2 50 3 JIS T 3250 4 5 3 UFR mL hr mmHg 25 JIS T 3250 4 5 2 509 2 1 1
34. 4 6 9 10 1 1 20mg 2 25 g g ISO 10993 7 11 1 11 2 12 RE RR
35. JIS T 14971 10
36. 1 2 3 UFR 4 5 7 JIS 14971 JIS T 3250
37. 6 JIS T 14971 8 16 169 JIS T 14971 JIS T 3250 4 6 JIS T 14971 JIS T 3250
38. 6 2 6 3 12 1 1 1 1 1 1 1 1 1 2 2 1 2 2 2 2 1 1 TMP YYYY MM OO ND OO ROR
39. JIS T 0993 1 1 14971 JIS 5 UIS T 14971 EK JIS T 3250 4 1
40. 3 2 Clearance 3 3 convection 3 4 dialysate dialysing fluid 3 5 dialysate compartment 3 6 diffusion 3 7 filtrate 3 8 haemodiafilter 3 9 haemodiafi1tration 3 10
41. 6 7 YYYY MM 8 9 10 UF 1 2 3 4 5 6 7 RS rr YYYY MM SC C CC CO
42. BB 12 4
43. haemodialyser 3 11 haemodialysis 3 12 haemofi1ter 3 13 haemofi1tration lg 9 1abeling 3 15 sieving coefficient 3 16 transmembrane pressure TMP TMP
44. 2 1 2 7 1 3 2 5 7 16 298 1 711 712 741 a 17 4 1
45. 30 0330001 4 4 JIS T 3250 4 2 GMP QMS 17 3 30 0330001 4 4 3 8 17 169
46. O 17 4 1 0401040 58 6 20 494 35 145 14 1 19 2 1 14 9 19 2 5 IVD
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