認知された規格に従 JIST14971：医療機器− 年3月10自薬食発第 条
Contents
1.2. 3
3. 2
4. 4 JIS T 14971 JIS T 0993 1 1
5. 3 4 5 11
6. 8
7. 17 3 10 0310003 4 5 JIS T 14971 0216002 17 2 16
8. 9 Rss
9. IJIS Z 4821 1 1 41 1 IMBg 17 3 10 0310003 ITIS Z 4821 1 1
10. 15 24 JIS T 14971 4 1 7 4 3 1 4 3 2 4 3 3 c 17 3 10 0310003 4 5 JIS T 14971 4 4
11. 7 13 4
12. 2 3 4
13. 2 ED 3 4
14. 24 24 2 5 7 16 298 1 848 1 2
15. 2 3 913 JIS T 14971 0310003 17 3 10 HR JIS T 14971 JIS Z 4821 1
16. 3 20 24
17. 8 _ 1 2 2
18. VS JIS T 14971 JIS T 14971 JIS T 14971 16 24
19. 5 11 lIJIS Z 4821 1 1 4 1 1 2 kBg 3
20. 4 5 6
21. 2 21 24 1 5
22. 2 17 24 2 3
23. 5 JIS T 14971 JIS Z 4821 1 1 4 1 2 1 C53211 C53X11 2 30 mm 8 6
24. 4 5 1 4
25. 2 3 16
26. 5 14
27. RS 1313
28. 4 1 1 Q IMBaq iT1S Z 4821 1 1 s 4 1 1 Q MBq 3 1 13 4
29. 18 24 7 8 1 2
30. 5 6 2 7
31. 4 13 16 1 6 9 JIS T 14971 TIS 2 4821 1 1 JIS T 14971 16 1 6 9 IS Z 4821 1 1 16 1 6 9 JIS T 14971
32. JIS Z 4821 1 1 4 2 0310003 17 3 10 JIS T 14971 16 0331032 17 3 31 2 1 2 2
33. 2 3 gt
34. 5 6 16 1 6 9 JIS T 1497
35. 8 9 10
36. 19 24 5 6 OE i 7 1 3 2
37. 5 6 7
38. JIS Z 4821 1 C53211 C63X11 1 5m 10 26mm 3mm 20 6kg 11cm cwW 3mm 20 6kg JIS Z 4821 2 1 40 20min 1m 50g 600 1 h 25kPa 2 MPa 1 5m
39. 3 4 5 6 7
40. JIS T 14971 J1S Z 4821 1 1 4 1 1 MBq kBq 3 kBq 4 1 2 1 C53211 C53X11 30 mm 8 0310003 17 3 10 5 13 7
41. NN MMNN IJ1S Z 4821 1 1 1213 4 1 1 IMBgl 2 _ 17 3 10H 0310003 IIIS 2 1821 1
42. 16 1 6 9 2 gt 3
43. 2 3
44. 4 JIS
45. 0213001 ISO 10993 4 1 5 4 2 3 13 2 1
46. 0213002 15 2 13 JIS T 14971 JIST 0993 1 1 0213002 15 2 13 JIS Z 4821 1 1 4 1 2 1 C63211 C53X11 30 mm 8 JIS T 14971 JIS T 0993 1 1 15 2 13 0213002 6 13
47. 1 13 2 3 4
48. 10 26m 3mm 40 20min 20 6kg 11cm 600 1 h 25kPa 600 2MPa lo 3m 20 20 6kg 2 30 mm 8 4 1 3 4 1 4 4 1 5 4 1 4 15 2 13
49. 3 125 198 4 4 1 4 1 1 1 MBq 30 125 37 4MBq 198 185MBq 2 JIS Z 4821 2 0 2 kBq 3 JIS Z 4821 2 0 2 kBq 2 13 4 1 2
50. 16 169 16 1 6 9 JIS T 14971 8 13 9
51. JIS T 14971 2 3 10
52. kBa 4 1 2 1 C53211 C53X11 30 mm 8 2 JIS Z 4821 1 1 4 1 1 Q _iMBg 10 13
53. 1 1 1 IMBol 3 15
54. 1 3 4 2 5 1 13 1 1 2 2 1 JIS Z 4821 1 2002 1 2 2 ISO 2919 1999 Radiation protection Sealed radioactive sources General requirements and classific
55. 2 1 2224 2 23724 1 1
56. 1 4 1 2 1 C53211 C53X11 30 mm 8 19 30 11 30 14 2 125 198 0715002 5 15 0310003 17 3 10 10
57. JIS T 14971 GMP QMS 0330001 17 3 30 4 4 GMP QMS 0330001 17 3 30 4 4
58. ation ISO 2919 2 3 JIS Z 4821 2 2002 2 2 4 ISO 9978 1992 Radiation protection Sealed radioactive sources Leakage test methods ISO 9978 2 5 JIS T 14971 2003 2 6 ISO 14971 2000 Medical devices Application of risk management to medical devices IS0 14971 2 7 17 3 30 0330001 GMP QMS 4 4 2 8 15 2 13 0213001 2 9 JIS T 0993 1 1 2 10 ISO 10993 1 2003 Biological evaluation of medical device Part 1 Evaluation and testing TISO 10993 1
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