汎用冷凍手術ユニット承認基準の制定について（PDF：1431KB）
Contents
1. lt kde eg ae i 0 ye ra E be JIS T 0601 12. LA amp CHA CHS Co 5 wee 42 8 2 LORE Hd 5meeRes SBSiz MSc 1602 Met BR Sok a se 4 2 9 JIS B 7505 42 10
3. 4 ER 5 6 7 3
4. 2 ap 3 JIS T0601 1 42
5. 1 75 ie 4 2 5 4 2 5 1 V on 4 2 5 2 TRY b ESOS pee 3 OLE ARAB CBA IS T 14971 2 ETRY SORIRA LAAT AR Bi STU PRTABB INC I13 2 EIEN BAK 8 ria ie os 1 arth 4 2 3
6. 30 hi 2 19 6MPa 30
7. 3 SEOs Ole ert 16 169 HIS T 0601 1 A 44 7 jain iam OR BURSRS AT Oaoal SAU ees ke OR hae A Sk DO Pen PROBE 16 b gt OPER IRB 169 ae a HIS T 0601 1 1
8. 3 IS T 0601 1 1 nb 6 3 ee se 1 PRB TORR BRIA TAOMMMOMM ETS ae lt Be PAA RORBES AOR cee ae 2 r v eta as
9. 4 2 11 2S gg ISO10993 7 5 Rr KES 5 1 SLI IST0601 1 6 BR 1 2 3 4 6 Hz V
10. 4 2 2 5 on 1 1
11. enti CHA 8 12 BHTUS I LVYAT ARE MIS T 14971 Rosas me ae ie
12. 3 4 5 6 7 3 60 3 5C 42 8
13. 14 HERO 2 c 1 5
14. 1 ae ee Ag 4 16 a ein ets BEANS AVERT TE 2 J AUIS T 14971 BS 6 Do Pa Cie Ge ON hide ota 2
15. 16 FRAME 169 Pee D 5 ea BOR HTIS T 14971
16. JIS T 0601 1 6 1 5 de BYR Ce SEI OE 4 SOBA LU CAA RK 17 8 10 0310003 MIS T 14971 a 16
17. 4 2 5 4 2 5 1 4 2 5 2 JIST 0601 1 56 11 d ae MIS T 14971 HIS T 14971 JIS T 0601 1 2 1 2
18. QC 2 3 5 1 5 5 22 MEM 1 2 17 3 10 0310003 4 5 oer Nee 3
19. ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 428 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 3 REMEROTA MEK 3
20. 8 GMP Q MS 0330001 17 3 30 4 4 1 5 1 5 16 1169 7
21. A A EE hal ee BIR 1 4 2 7 4 2 8 4 2 9 ROSSA ROLES RO RE 16 169 FI 1 4 2 2 Wee 4 2 5 4 2 5 1 4 2 5 2 2 5 JIS T 0601 1 1 6 a TT ae CURA Ras ERR en ne nn on TOT TITY OY IV TT gy
22. GMP Q MS ERE RS 0330001 17 3 80 4 4 1 29 4 2 10 8 OR EDK A eRe te COREA LL ART Chak 16 FRAGA TR 169 GS 1 5 2 5 mm Pa ERIE aS cae 0S PIES OKA ERO pak feat i Te PER Oh SB EE I BE CER 16 169 amp 9 FURR O SE YMRS
23. fata ws te pe Ng rm fe etic ai 7 u PT MS Be OSCE ke SE BER 0330001 gt Fak 17 4F 3 A 30 ae 4 2 eg 16 169 ad ed cI PAA A td 10 10 bk OF Fis A DAE Oph OARGE CARSE amp FLAS cae enol Mee EE
24. JIS T 14971 tL BE SE FB 0213001 15 2 13 CEP AT Bef BE os 4 2 1 2 sha Ne ero BAA RIRBEAR ELC IS UT OPIN ARE A awn hie a aay AQ JIS T 0601 1 1 43 1 2 UIS T 14971
25. ASTM F882 84 6 2 6 JIS TO601 1 A1 6 ASTM F882 84 6 2 7 ASTM F882 84 8 ASTM F882 84 6 2 10 ASTM F882 84 6 2 11 2 Te 1 7
26. 0331032 17 3 31 2 1 2 2 Chat tte
27. TAILS OBER YI felipe nad 4 MIS T 14971 JIST 0601 1 1 6 3 5 MHIS T 14971
28. 5 JIS T 0601 1 25 43 1 44 4 45 4 2 1 1 2 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity 39 JIS B 8241 1 sprig a alas alae PRONRAMILREF ORME
29. 3 4 es 3 5 3 6 4 4 1 JIS T0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 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 Concentr
30. Ne a Or RI hl a RE 36 RED BP S T 14971 HIS T 14971 8 CBIR 1 4 1 4 2 JIS T 0601 1 0 ee 7
31. TK EEO ice LAV hon 2 Ri 3 CE 1 4 9 6 2 1 4 1 1 9 2 1 ae ee ere eee Ar pe 1 7 2 1 6 0216002 4
32. 30cm OMB Im RBS 9Ocm 90cm 3 2 60 12 ASTM 12 2Sppm
33. 47 6 1 495 BS 0 ASTM F882 84 6 2 1 20C ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 ASTM F882 84 6 2 5 AC
34. V GRU 1 2 8 Peer mae UIS T 0601 1 2 1 ey EE cei PARUSR B6 202 JIS T 0601 1 2 1 1 1 2 9 4 7 JIS T 0601 1 1 LRAT
35. 42 12 IS T 0993 1 42 13 JIS T0601 1 23 BH BRU 4 2 1 4 ASTM F882 84 3 1 1
36. 42 6 60 C 42 7 60 C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed CRN Temperature Reproducibility 3 1 a 1000mL 1000mL 30C 2C 4 2
37. ERRORS Sok ey 16 FRESE A 169 5 JIS T 0601 1 Bh 10 56 3 a 57 58 _ GIR 1 es 4 2 8 4 2 4 UIS T 14971 mer m
38. 5 1 6 bed Cl 16 SERRE OA DATES fa Cd 0 169
39. 7 19 20 58 ppp yA Ll A A I re 13 PRP BAERS FARR JIST 0601 1 1 Ab 1 23 24 45 1 4 2 MJIS T 14971 lt oo
40. CTT TT TT TT 2 3 BAP SRT SHE ICHAT AS 4 RHR a
41. 10 2 2 49 IS T 0601 1 2 2 86 202 1 3 to 2 r
42. 2 1 7 3 3 1 0331012 BUYS 2 5 7 1 955 19 3 2 1 2 1 3 EEL
43. PH REC IBD L CORRES Ay 42 4 FE CA Y 4 FERRERS OMA a Ve Ba 5 ITIS T 14971 CR 1
44. FEC 1 4 heb hese Ps
45. BAG 17 3 10 0310003 SUS EAR OUST IS T 14971 H IS T 0601 1 1 BB 6 8 BUR 1 2 3
46. SITAR 2 HORE AREER RIFSTH 3 PER REDRES RSS C EB RGAE A be oa 4 _ 5 6 1
47. 0302012 1 9 3 2 HE Bin 5 1 4 5 1 4 19 2 1 1 4 9 1 9 2 5 I VD za 1 7 2 1 6 0216002 FF tare
48. 424 5 2 9 KOSS a MJIS T1497 OO oda a IS T 0601 1 1 24 25 45 GIS 1 4 2 MJIS T 0601 1
49. 4 2 5 4 2 5 1 4 2 5 2 JIS T 0601 1 BR 44 4 56 11 POPU ROR PORTA RR rs Pk as 6 TOPE ER EEC RR LC AMOMADT OTR MARAT _ AIRE ILE OD BRR gt DIBA MIS T 14971 1 4 2 5 42 5 1 4 2 5 2 _ 8
50. HIRE 1 Leer 25 1 10 MEMES AT ARR GE th 1 42 7 Le wa 3 cid 4 2 8 4 2 9 Bee 2 HEE ROS noc Se OMI BPE FAUEROUPERIO PEA Oe 3
51. 36 202 IS T 14971 JTS T O601 1 1 BB 5 42 43 52 56 57 rr 59 FUE 1 5 2 BABE 5 aA STU RICHES TU AZ SIS T 14971 CERT MIS T 14971 3
52. 2 JIST 0601 1 1 JIS T 0601 1 2 1 2 JIST0993 1 1 HIS C 1602 JISB7505 JISBS8241 JISB8246 ASTM F882 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ISO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3 _ JIS T 0601 1 JIS T 0601 1 2 JIS T 0993 1 JISC 1602 JIS B 05 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 BERN O 3 2 RRA 33
53. 44 4 44 7 jal YAS OR 6 16 169 9 IS T 0601 1 1 OBB 44 4 4 7 tain VEER OWME 2 GPRS EO a Le gt 3 ret EE BE SRC PER ORR AREY
54. 84 7 3 1 Cryogen Exhaust 425 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 4 2 5 2 42 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide ae 1 1 28 32 2 13 le 9 Off KE PTT TT SR 42 17 0
55. JIS 7 1 4 2 MIS T 14971 3 16 169 FRY 4
56. 6 AVA W 7 8 JIS T 0601 1 6 1 5 1 2 1 JIS T 0601 1 6 1 6 7 7 1 1 5 1 3 JIS T 0601 166 1 EEARRONA ROMANS 1ST C6011 56 3 0 2 1 4
57. ations 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 i of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 JIS T0601 1 21 4 211 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Integrity RK 3
58. closed cryotip a 4 2 2 TRA ASTM F882 84 7 4 Thermal Insulation 4 2 3 ASTM F882 84 5 4 1 2 4 2 4 IS B 8246 4 2 S ASTM F882
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