薬事法 (昭和3 5年法律第ー`4 5`号。 以下 一『法] という。) 第ー 4条第ー
Contents
1. 2 JIST 0601 1 1 JIS T 0601 1 2 1 2 Mm JIS T 0993 1 1 JIS C 1602 JIS B 7505 JISB8241 JISB8246 ASTM FS82 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments JSO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3 JS T 0601 1 JIS T 0601 1 2 SIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 72. Lenny os 1 UE 4 2 5 TEAR OS _ 2 5 1 a 4 2 5 2 3 T 14971 7 Oht a ERRORS CORA SRE
3. _ k 5 6 ERPALEST SE
4. AIBC A O BEAM SHIRA FE AREER IED 3 16 169
5. RUE 42 no 6 1 4 2 2 1 4 SRST Sie 8 BW 1 4 2 7 5E 4 2 8 4 2 9 2 SERRA SRO dont A
6. JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 1 ky 4 2 2 MGR ASTM F882 84 7 4 Thermal Insulation 4 2 3
7. US T 14971 bel BAR aT ORM SIE ls 1 42 IS T 0601 1 1 BUA 10 2 2 49 DIS T 0601 1 2 1
8. 16 a 169 3 v ie 1 2 2 4 2 5 1 2 5 1 HEY LES OBE RREE 2 5 2 3 BURA LAST SM SIAR IS SRE oe PABA REIC RR SU CTA 1 5 Sim nl JTS T 0601 1 1
9. IS T 0601 1 6 0 BFR te RRUMEES 9 3 4 3 Hz fe Vv 6 A VA W _ 6 T0601 1 61 MELEMBOMAONM ORR eh LeERIOR 5 1 2 1 TIS T 0601 1 6 1 6 EERE Cee eRe ane ee ar ee 513 dane bcee TS T 0601 1 6 6 1
10. 3 3 19 6MPa 30 4 2 1 2 JIS T 0993 1 1 4 2 1 3
11. 1 4 2 5 4 2 5 1 4 2 5 2 TBR OU JIS T 0601 1 PR 6 M4 4 56 11 d bere ws MIS T 14971 Bl
12. 16 69 GMP Q S 08830001 17 3 8 A 4 4 BNI a YEH Bl 1 1 __ 42 10 8 RAMS ROINILRORV ERB
13. 1 APT RER I REN R ORR EMME ROR 2 3 4 ene
14. MIS T 14971 2 EAA EAST ORNs PELASEHA SH SIVCWS TAL Vb ORR OR JIS T0601 1 1 6 8 5 Gig 1 4 2 3 4 2 4 6 5 2 9 ROBE 6 RIS T 14971 wee See
15. ST 0601 1 2 BRATS Le JIS 7 FERED IASB CBU 1 2 BER OE HIS T 14971
16. 16 ALES ate POA STLICRME ICE TSO 169 MLS T 0601 1 1 44 4 44 7 BARI tat SURES FYTTE fede See sae aa 169 DIS T 0601 1 1 44 4 44 7 2 MCM ee
17. 3 2 60 12 ASTM 12 25ppm 42 6 A ME OSIRIA 60C 42 7 0
18. AI 3 Ly SUT SA RALERT ERA PORN SAVICBUB INES TU AZ _ ST 14971 BIE 1 4 2 8 2 AnERERREORLE ORT By ry Fe NR gt A a
19. 4 16 169 IIS T 14971 1 haa 5
20. ASTM F882 84 7 2 Mechanical Integrity 4211 1 ASTM F882 84 9 Test Method for Mechanical Integrity 5 MEARS 3 5 5 JIS T 0601 1 25 43 1 44 4 43 42 1 1 2 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity th 1 39 JIS B 824
21. RAR aus TS T 14971 16 169 JIS T 0601 1 Rs 10 56 3 a 57 58 1 4 2 3 4 2 4 ees 5 ERED 3 SRBC lt i RST CHM EOMADADIS T 06011
22. ASTM F882 84 5 4 1 2 Ne JISB 8246 425 ASTM F882 84 73 1 Cryogen Exhaust 42 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 425 2
23. busi FA 7 ST0601 1 mA 36 202 19 20 58 CePA Sen 13 BERRI BRR Re JIS T 0601 1 1 8 24 45
24. 1 GRRE CHAT SOLER 16 AHO S 169 Beg TS T 14971 BACT BH OMAR OLS
25. 16 169 DIS T 14971 6 1 4 1 4 2 HTST 0601 1 BG BS 7
26. ASTM F882 84 6 2 6 JIST 0601 1 A1 6 ASTM F882 84 62 7 ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 ASTMF882 84 6 2 11 2
27. 16 169 3 MCh GMP Qi Mas MS CROBBRUG RO HITE 0330001 17 3 8 A 4 4 BUA 1 5 1 5 7 PS 24
28. 42 53 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 0 1 EA 28 32 2 13 te i Ene hq Aa SM A 4 7 30cm MEA 90cm 90cari
29. 1 4 2 IS T 14971 2 PRE EDY ORR LOE oan eee wy ae CHLARV 3 HERSMED the LOU f 4
30. HIS T 14971 EEF 1 6 ROAM eT 5A RR 0331032 7 3 31 2 1 2 2
31. 6 L eee ene 1 5 2 3
32. 3 j 4 MITEL LOR AS 5 6 2
33. 4 3 47 6 1 495 abe Recline Nicer YF SRASNILREAOKEICOWTCORS CO 0 REDE OM aC OW TI ae ASTM F882 84 ae 1 20 REROA ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 ASTMF882 84 _ 6 2 5 in ac TIPE SIME ABIL BU EARS
34. 2 86 202 ST 0601 1 2 iB RAC SRR 2 36 202 ST 14971 5 PRUE RE i Beh MIST 0601 1 a PS 25 2 43 52 56 57
35. BER OTHER JIS T 14971 au HoMbA MLA EIR 0218001 15 2 18 CHUMP ARR a 42 1 2 EC 1 si 42 pe IST 0601 1 BE ROR A 3 1 IS T 14971 2
36. 0330001 17 8 30 4 4 10 BRO BRRUS i ko Cte Baa eS BIA 1 16 169 amp 5 1 4 17 8 10 ERR 0310003 T
37. _ 7 8 sae oat 1 2
38. 1 ae 2 5 4 2 5 1 4 2 5 2 GRATE RAS OB Lk 8 Be SHWITA aA 16 169 TS T0601 1 1 big 144 7
39. 7 3 60 3 5 4 2 8 3 sees Meee aay aie ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 3
40. 6 3 11 2 3
41. far ChLARY 8 JIS T 0601 1 bag 6 BUR 1 5 e MBG 17 3 10 310008
42. 16 169 BN 1 5 2 5 9 JARAERREO TRL RETR LOM 16 BEES 169 GMP QI MS
43. sp 4 2 7 4 2 8 4 2 9 2 8 i 3 a Pa re
44. 42 71 ASTM F882 84 11 Test Method for Determining Closed Cryotp Temperature Reproducibility 3 1 1 1000mL 1000mL 30 C 2 4 Q 1 IO SSO RE 3 5 6
45. 31 32 3 3 3 4 3 5 3 6 4
46. RE 2 a Go 3 1 4 9 6S 2 1 4 1 1 9 2 1 9 8 1 7 2 16 0216002
47. 1 2 11 3 SAA CHER SH SRE CHD 4 WRLC R ARREST 2 77 A HR RR OM AIRE 5 sa a eo ae 1 1
48. 59 GU 5 2 rs T 14971 i 3 IIS 14971 GBI 1 4 2 5 1 0 GI ft
49. 3 bey ts RRR PRE bRORAK ADRS BE SER CHL Z 4 AF ft ke
50. 3 NM 4 ee ia 3 5 amp Oa SAIC JIS T 0601 1 2 1 2 v 1 BSE 36 201 6 BM Sneak CR he EEO AVIS T 0601 1 2 1 BB 2 7 AERTS E 9
51. ERED RLUICE RIE OH Pope 4 2 1 7 3 3 1 0331012 BUS Ete 2 5 7 16 298 1 955 19 3 2
52. 50 SC 42 8 2 COMET DD bREL RET SIBSIL MISC 1602 6 5 4 2 9 JIS B 7505 4 2 10 42 11 25 gg AERIS OS CRM A ASR eI AE YP 5 51 5 1 1
53. BAAR O ma ee ie aber 2 s 1 4 pan CHB 5 RE HRN 9 Ct ABR 1 2 3 i a 515 52 Q 2 17 3 A 10 0310003 6 3
54. 3B 3B 0302012 1 9 8 2 ir A Gye ERR EB He 3 5 1 4 5 1 4 1 1 9 2 1 i 1 4 9 1 9 2 5 I VD at Al 1 7 2 1 6 0216002
55. 4 1 JIST 0601 1 JIST 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ape ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotip 5 4 Monitoring Devices 6 Disclosure Labeling and Documentation Requirements 7 2 Mechanical Integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations of Nitrous Oxide 7 4 Thermal Insulation 9 Test Method for Mechanical Integrity 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 13 Test Method for Determining the A euiacy of Temperature Monitors Cryotip and Tissue 42 4 2 1 JIS T0601 1 21 4 2 1 1
56. 1 AM 4 2 3 24 4 v 5 BRR REED Oe a MIS T 14971
57. EMORY TPIS T 0601 1 1 221 23 24 25 haar 1 BES EEA 4 2 5 4 2 5 1 4 2 5 2 raps T0601 1 56 11 d Lae Bon IS T 14971
58. 1 SOE 5 ee 30 Loe Q
59. 4 MTS T 14971 bt UIS T 0601 1 BS go 3 HDRES AR 5 FAD HIS T 14971 _ PAs EO ST 0601 1 1 fis
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