医療現場における滅菌保証のガイドライン 2010
Contents
1.2. ul m EU uil Tu EE 5 2 7 1 2 7 5 28 4 1 10 Cf 2 amp t f amp 10 OF Sv
3. 3 1 6 1 amp IE calibration FR RDA Hi CAT 5 f E 163 Eun WEIT oo 3 1 4 3 1 5 REARED
4. MAT biological indicator BI chemical indicator CI 3 performance qualification PO PQ f PQ PQO PQ reference load 19 1 5
5. T 2 1 4 WD 2 1 3 WD VE
6. BL BI 291925 275 BI ROLL BI 1 1 6
7. 2005 ES KELT E Baul cme BOR IVY 2005 VAN ee a DB
8. 5 1 6 5 1 4 5 1 5 1 amp IE calibration H3 5 5 1 4 E 5 1 5
9. orl tm 2 FAH 3 Gl REEE pA 5 WD
10. 6 2 6 1 2 7 6 n 6 2 7 t f amp 1 10 2 10 H Nr H Nr 6 2 8 1 A 2 amp IE calibration B 3
11. BK es parametric release ISO 11140 1 parameter validation FE EME ESAS non condensable gas NCG 77
12. 6 2 6 2 1 1 4 X 6 2 2 A 6 2 3 1 A A 2
13. H H bal AO UR Se FEE ORR OAREOM BH Ju
14. IFAS 6 CI 1 CI 8 1 4 CI PCD CI 1 CI AB CI SN ae pln ky ER CI BI 1 j
15. 7 chemical indicator CI 10 20cm 3 4 4 4
16. 2 1 5 V 2 2 3
17. 2000 2000 revalidation requalification H
18. 3 OME XE 4 SORE TT MX ME A SORA V ATOR CREAR ENTEN W fS pm 2
19. 3 ELV n 4 R et RIZ 1 2 IDA MER ED E
20. OQ 4 5 OO 225 ER EOG EOG OR ll uu WwW Het M U N J Ed S IU N X A EO RFE PO SAL 2 B T D DREI DS N PCD BI
21. 7 1 5 HED do DN A CI CI CI CI tit 72 7 2 1 CI CI
22. 13 1 13 2 13 2 1 1 4 7 2 9 9 17 12 22 1222001 17 12 22 122001 1 A 2 9 9 17 12 22 1222001
23. 12 6 12 3 101 12 E ches 12 3 RRR FUA OSSSRBI 4a BR 1L P 1 1 1 10mL D 0 01 100ppm 66 1L 5 5 6 2mL Eng 10 1L 10 1mL 1L P 1 1 1 100mL D 0 1 1 000ppm 606 1L 5 5 6 20mL nga 10 10
24. BOG 42 4 2 1 M d bat 4 2 2 1 EOG EOG A 2 EOG EOG tA 3 EOG OUR BEM LE EOG
25. A 3 IQ OQ PQ tit B performance qualification PO E WD mL F Paran E zi mH Af 9 3 5 n 9 2 3 1 1 2 3
26. 2 4 2 4 WD WD IQ 20YY MM DD XX 123456789 20YY MM DD ia g BERG HE 7J 0 1 0 8MPa BERG HE 7J 0 1 0 8MPa Hg 5mA F 10MQ 3 OQ IQ WD
27. 1 1 i fim i dim
28. _ gt ta TAA DB ht 9 3 9 1 2 9 1 1 2 3 4 25 2 operational qualification OQ
29. UE 2 BI CI BI CI 7 chemical indicator CD 8 biological indicator B
30. 4 5 chemical Indicator CI PCD OQ UB PQ SAL SAL BRE 2 BI 106 Bese BI ETI SAL
31. b 2 3 4 4 1 5 ee 3 9
32. AI 1 CI BI 1 JE JER KURZ K o THER 2 ISO 11138 1 BI ISO 11140 1 UA 7 1 3 HIR BI 3 PCD CI PCD CI
33. PCD OQ PCD a PCD Association for the Advancement of Medical Instrumentation AAMI PCD 16 3 41cmX66cm 16 x26 TEA 15cm 6 7 8 BI
34. N 3 AX Ld HE DEJ Ad Sv LARA IC LS 4 1 are amp FG 5 gt
35. A P n i a ILLI a YYT ar g i Nn S i 3 3 BI CI PO PQ SAL10 BI PCD PCD PCD PCD ANSI AAMI ST87 ANSI AAMI ST79 PCD PCD EN867 5 PCD EN867 5
36. operational qualification OQ EOG OT aeration F oC 2 C F value F ee s cT 2z T 121C Fo value
37. SAL 10 Ek D Q a BI b D
38. er Qc 3 4 a 5 iX W Poo hye 6 1 4 6 1 5 EOF ATT A
39. 1 ld A 0 25MPa 0 5MPa e E i c BEBE I b c 38 d X o Pil ISO TS 17665 2 X o _ 50 38 g TE i 450mm X8 d 0 15MPa 0 3 MPa BK BEAREN d 2
40. 9 3 9 1 3
41. PQ 4 2 BOG PQ PQ 3 4 1 5 PQ 4 BOG E 4 1 5 3 PO
42. M BA E BI CI 10 EX Ay JE 3 FERIAN
43. 9 cen oe 4 1 4 EOG JIS T 7323 2005 1 IEC 6010 2 040 2005 AY it 1
44. 5 1 lt gt IQ QU OG OO OO EO R OO OO FE 1 IQ 2 1 2 1 3 1
45. 11 BER BEDA 10 6 6 1 9 1
46. 105 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 ISO 14937 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices ANSI AAMI ST79 2006 Comprehensive guide to steam sterilization andsterility assurance in health care facilities ANSI AAMI ST41 2008 Ethylene oxide sterilization in health care facilties Safety and effectiveness ISO 11140 1 2005 Sterilization of health care products Chemical indicators Partl General requirements ISO 11138 1 2006 Sterilization of health care products Biological indicators Part1 General requirements ISO 11138 2 2006 Sterilization of health care products Biological indicators Part2 Biological indicators for ethylene oxide sterilization process ISO 11138 3 2006 Sterilization of health care products Biological indicators Part3 Biological indicators for moist heat sterilization process ISO TS 11139 2006 Sterilzation of health care
47. a 4 It 0 E vd Ubri Ra 5 R X KR PEK SARI DT AT TII Poot HEB 1 ise FY VIP AY tit te ES Tee oque
48. gt E EHS SHORE ARATA 4 vier wo oed nd prvions serso adven aber RT shdsivs we indicateur de cuori vegarare WES E 6 4 CI CI 9 LL TS CI BI TL TOR
49. NaQl 3 E EOG Al H BH BB ed Ait BS E E 4
50. w OB 3 1 5 3 1 5 jj AK au i hh T
51. 1 2 amp IE calibration 1 3
52. 4 5 3 1 OQ 4 4 4 f ii E LAT SD OO URL B EE S TU
53. 5 6 1 7 6 1 6 sterility assurance level SAL CI BI 1 6 1 5 RAR
54. 3 A A 11 11 2 4 A 11 2 5 A 12 12 12 1 12 1 1 ia EOG EOG FRAAI
55. WD 2 installation qualification IO WD 1 2 WD Ei ARR
56. v Sy 3 operational qualification OQ PLN Ei E J c HER i Nude OQIZ IQ a ee AR YE E
57. BEOG zh cT 5 i 4 4 1 3 REY 1 p 2 EOG EOG
58. A 3 B nu 6 4 R WE A 6 2 4 1 A 2 A
59. 5 amp JR 2 1 5 1 5 ET wae E CHN 2 1 6 2 1 4 WD 2 1 5 WD FAL 1 amp IE calibration A Wo KRA WD 2
60. A 1 2 3 1 2 3 4 chemical indicator Cl 5 6 4 11 2 2 A B
61. XE Ek WN ASE T 2 Fit BEE FIRII T OX 1 2 installation qualification IQ IQ
62. ISO 11138 1 2 3 4 5 7 chemical indicator Cl 6 7226 oo d de 4 on value SV 4 6 5 7 3 5 3 6
63. 22 t 2 2 1 1 2 1 IR 2 2 2 WD A 3000 A 2 2 3 1 A 2 A 3 AVR L 7 Dorf Vo 0o FRI T Ju A 2 2 4 WD
64. EOG 4 1 5 4 mg 2 EOG KARR 3 CI BI 7 1 3 CI 7 1 4 8 1 5 8 2 1 BI PCD BI CI PCD ANSI AAMI ST41 2008 4 8 4 928 H8 72358 PCD AAMI PCD
65. 2 amp E BUS T FLOR B 3 BIN ay B 4 4 ethylene oxide gas EOG 41 R 4 1 1 0D P 2 Suh mds OS SR 4 1 2 1 EOG EOG
66. biological indicator BD chemical indicator CI BI L 6 2 BI CI 2 PQ
67. 1 cd Certified Sterilisation Specialist CSS 2003 116 38 32 8 LVI 38 2010 7 1 179 166 2 2009 XE washer He FR Heike
68. b 2 b L 6 iU i Lt AAT in a
69. time related sterility maintenance TRSM Bat UE EK event related sterility maintenance ERSM AL E CA NEA disinfection load endpoint installation qualification 1Q
70. PCD Association for the Advancement of Medical Instrumentation AAMI PCD PCD Gh PCD BITOR aL PCD ae EN 60 1 1 1 6 E SO TC 198 MOV ADE FE TCR BI CI
71. F Fi A N 4 XXX Ox 2
72. J HR 1 8 H BI d
73. 1 1 2 RAD SE 1 1 3 sterility assurance level mu fie SAL E 10 SAL CHE BT 2 Jc b LC ID RO 45 LOBED EB Ze UR 2e FH CRA LER 23 U 77 V a VAR E72 5 d SAL
74. zu 7 IQ 1 2 E 3 EX E i525 5
75. E T w A P 3 1 4 JIS T 7322 2005 JIS T 7324 2005 1 1 JIS C 1010 1 IEC 61010 2 041 2 3 4 5 2 1
76. 5 1 5 1 3 1 2
77. 4 1 ppm FDA 1978 GOg 5 071009 100g 7 X EOG 1 EOG EOG 2 3 2 4
78. 8 1 2 1 ISO 11138 1 Sterilization of health care products Biological indicators Part1 General requirements 1 2 ISO 11138 2 Sterilization of health care products Biological indicators Part2 Biological indicators for ethylene oxide sterilization 2 3 ISO 11138 3 Sterilization of health care products Biological indicators Part3 Biological indicators for moist heat sterilization 3 CGFA 4 ISO 11138 4 Sterilization of health care products Biological indicators Part4 Biological indicators for dry heat sterilization 4 EARE O T D DEWE 5 ISO 11138 5 Sterilization of health care products Biological indicators Part5
79. D 5 mg 2 TS 3
80. 5C O 9 7 ON AMEE cone T O Wo 7 1 Ree 2 3 HEC SIE Osean sem cats 53s SO O WD L E 1 1 10 1 14 5cm 5 50rL 24 B 1 3 5 35 40 Ay B 1 4
81. B 5 A 6 X RAO BEML A 3 2 4 A 3 2 5 SAL A 3 2 6 1 amp I RAR E ERRET OR BRUSY T avicHweesu B 2 a i installation abd IQ IQ 1 DEDE a
82. 4 1 3 BEOG EOG EOG BEOG 2 EOG EOG EOG EOG material safety data sheet MSDS MSDS
83. 2 3 CI 4 BI CI BI 1 1 4 5 WX
84. BI PALER BCR PQ BI PQ 2 PQ KAYO EUR W PQ PQ
85. process challenge device PCD BI 3 3 PRE 11 1 2 9 4 ff 2t 1 2 E
86. 4 E LA 5 RA Mit EOG EOG 6 EOG EOG BEBOG B 1978 Foo 4 1 3 ISO 10993 7 EOG R d and Drug Administration FDA E EOG
87. 1 BW 2
88. HE X JIS Al Wy ili L ERE KA POWE ew H X EZE DI WORE IEC6010 2 040 200513 1 101 Hk TJIS T 7323 2005 Alar tC WOK JE X ES A 3 t 4 5 PATA BH 4 1 5 Ta device d gt SAL
89. kot PCD PCD 1 1 7 HRZ EN PCD E MM ae F mH Ala DE ii TH H 1 PCD SO TC 198 m 1 1 PCD PCD
90. 4 p L Al IQ OQ C OVER E erformance qualification PQ E esl c PH MECC QX HC BTS E d Ej SE CPA e P 6 PQ xd dm SAL 1
91. EAE HOBIE UTIL 3 2 mM napa MU TR UM 3 4 g zu Ao Avo
92. UL A Y 2 x BR 9 2 4 B uii 9 25 OF B 3 n3 9 2 6 IQ E B 10 10 10
93. 1 2 1 EJ 3 JIS Z0238 ISO 11607 1997 Packaging for terminally sterilized medical devices ANSI AAMI ISO 11607 1997 Packaging for terminally sterilized medical devices OTAU b EE bY ORR a I5bmmiAXHEr UL ABRIL O mim de ARTE CZ 180 300mm N 15mm 2 ASTM F2054
94. 1 TH 4 mg 5 52 5 2 1 1 4 X 5 2 2 A 5 2 3 1
95. sterilization process MRE HEMT 51 sterilizing agent AL monitoring Y eret COPA Dee recall 1 1 E 1 1 1 MIL D E ZH
96. WD A 228 A 2 2 9 1 1 fi B 2 B 2 B 1 amp E A 2
97. CR EU T 2 A A 1 Ki USUS 1 E CE 94 B P d m z 2 1 B 1 B 1 1 Bi lsd mg HB 2 1 4 pee bid Miaka
98. 30 50 76 32cmX23cmX5cm 3 7 10 4 1 76 37 48 2 4 1 4
99. re A 4 performance qualification PQ IQ OQ WD B 2 2 7 1 1 WD A 2 C 3 A 2 SX WD
100. A ACRES A WD SO 15883 A 600 WD A 3000 World Forum for Hospital Sterile Service WFHSS A 600 B A 3000 http www wfhss net html educ qtg qtg001_en htm 90 93 C 5 10 A 3000 12000 mg HB 2 2 2 AE C 70 10 60 80 1 90 6 70 100 600 80 10 90 1 1200 93 1 2 1 3 1
101. ERSM ZA ELT KED 1 1 Hi 1 Oo tA d qualification OO 155 Centers for Disease Control and f 140 sm i E W
102. A 3 A 3 operational qualification OQ IQ OQ OQ X A 4 performance qualification PO OQ PQ PQ PQ PQ OQ PQ B
103. ft BEMIS 2 1 9 1 1 m WD 2 8 3 2 2 1 7 rr
104. 2 11 1 11 1 1 f 11 11 ie Hi C BI 4 E E biological indicator BI BI BK
105. 9 1 7 1 2 3 4 9 9
106. 2 PCD 3 4 5 PQ PQ PO PQ 1 13 3 PQ BR PO 3 2 3 3 OQ
107. 2 BI CI BI 1 CI BI Geobacillus stearothermophilus E 2 BI TOR CI CI CI 1 150 OPK CI BI HL BI 1 BI 6 1 8 Dx 10
108. MSDS 5 6 1 RREK REA 6 1 3 1 2
109. TWH 0 MARAE RAT SEO CIS 2 ISO 11140 3 ISO 11140 4 ISO 11140 5 1 ISO 11140 3 900mm X 1 200mm 30 6 A Yom 27 5 cm F
110. PCD 3 5 PCD 3 5 CI BI A n x 3 5 PCD 3 6 b b 1 PCD OQ HERO EZ b 2 b 3
111. 2 Alle SE ARICEETADORBSV EOGIX pH EO pH EOG 100 EOG EOG
112. A Bin 2 WD 1 Gl ibs 887 ne
113. A 5 2 5 SAL A 2 A 5 2 6 1 amp IE calibration WH RE EZK SA Kl WATT AS Aas ORE B 2 installation qualification IQ IQ Td 5 1 A 2
114. B material safety data sheet MSDS loading configuration RA T department manager D 10 1 10 Z Value d cleaning
115. EOG 400mg L 1100mg L EOG 8 mg L t EOG 4 performance qualification PQ IQ 0Q 4 1 5 D XM
116. 1 1 4 REIF Yay operational qualification OQ PO PO 13 1 6 IQ OQ 1 IQ ERA installation qualification IQ installation qualification IQ performance qualification PQ PQ 4 1 6 5 1 6 6 1 6 Can rds HCM amp LCIQ OQ2 E e ce Was
117. 3L 12 4 10 3 6 10 10 60 9 50 10 60 n 012 3 12 4 12 2 2 9059 0 05
118. E E Hx E E 2 fio L E EOG EOG 4
119. 2c FR iil RE Wi A T o x KEF gt HZ HE ICES Al fir Ju iE J H3 3 x E AITO Hi l Iu of 2 installation qualification IO E PRI 1
120. 7 1 1 SMA 1 AN xn ARER 3 0 5 10 0 5 5 5 EOG 1 i 15 19 60 10 RH 15 54 1C 60 10 RH 15 30 1C 60 10 RH 15 54 1C 60 10 RH EOG 90 1 601 C 85 RH EOG 7 chemical indicator CI 1 50 0 5C a 27 0 5C 50 0 5C 27 0 5C 50 0 5C 27 0 5C 7 2 3 4 RHR ALE SV 0 Wer 0 sv o Sv 0 svro gt 30 RH SV 25 SV 25 gt 30 RH
121. 2000 2000 Lies 3 P U SJ 6 oe
122. CI process challenge device PCD conditioning cold spot ee revalidation u NAN RF Y reference load 224 Sat LE
123. 3 5 OO OQ 20YY MM DD XX 123456789 20YY MM DD 10kPa 10min kPa min fe 6 0 085MPa MPa B 3 FE IRE 1C XC R8 XXxXx C B8 X X min min 0 X XkPa 5kPa X X X kPa
124. H BLUE SMVC ERI 5 operational qualification OQ R44 OR ls LC BER HI OQ Fynnon AKM E
125. A 5 5 5 1 fe m 5 1 1 Q0 1 2 5 1 2 15 30C COR 5 1 3 4
126. A 7 X BEOG A 4 2 4 A 4 2 5 SAL A 4 2 6 1 amp IE calibration B 2 instalation qualification IQ IQ BEOG 1 A 2
127. 7 chemical indicator CD 4 CI CI 7 1 CI 7 1 4 CI 1 CI CI ee ae HCI ISO11140 19 G Waele CI CI
128. A A 2 A 3 B 4 A 5 X A 5 2 4
129. He ES BI HETE Er 1 LEI CRT OD 1 2 19 19 25 BI 4 4 WEE WA Daa OM AS E E
130. A 4 2 3 1 A A 2 EOG BOG B 4 3 A 4 B 5 EOG A 6 EOG EOG EOG
131. 2 5 OO WD OQ AER 20YY MM DD XX 123456789 20YY MM DD HIE 5C C 25 C C CIR F OMAT 2 5 C RG mL ve mL wel RG mL v mL v mL v mL v Fo R5 HER us S pH 4
132. A A A 1 2 3 11 2 3 1 2 A
133. Biological indicators for low temperature steam formaldehyde sterilization 5 6 ISO 18472 Sterilization of health care products Biological and chemical indicators Test equipment 7 ISO 14161 Sterilization of health care products Biological indicators Guidance for the selection use and interpretation of results ISO 11138 1 BI IH BI AM BE D Z ISO 11138 2 PH ARAL ISO 11138 3 WEA BI BI 8 1
134. 2010 80 10 5 2010 2010 OHA PIA Vitis disinfector WD 2009 10 3 W
135. 2010 Guideline for Sterility Assurance in Healthcare Setting 2010 12 1 Japanese Society of Medical Instrumentation EMR 2000 ae 2000 2000 2000 2005 11 2 Certified SterilisationService Technician CSST 3 10 Hi 2 262 3 353
136. Joint Commission on Accreditation of Healthcare A ESI ERLA BER KR Syu gt HX E z 9 2 9 2 1 ORE EBERT AC O 20 A i 922 1 Q 2 operational che Ta ERSM TRSM EJH installation qualification IO TRSM TRSM
137. 23cmX30cm HP ORE 25 28cm 7kg 100 1 ISO 11140 5 25cm X 30cm BA 25 28cm 4kg 5 30 ISO 11140 322 ISO 11140 4 20mm 2
138. EOG flushing le Yd DU equilibration time 23 holding time sterility test E 1 10 1 10 sterility assurance level SAL sterilization
139. chemical stelirant 9 ERE Bacillus atrophaeus Lee E 12 1 MR S A gt gt gt RREO TRE M 70
140. 4 223 E 3 OQ 3H PI FA fn mm HE His PAE r i cree eae W mg operational qualification OQ IQ OQ OQ
141. 800L 350L L Gi KOE AE EAICBRLC TZ 7g V NICA c EOG EOG otk 385 70 C SKU a sy aes HD Cd OD If
142. ISO 11140 1 1C6 e dederit e 5 2005 ISO 11140 1 CI ISO NU chemical indicator evaluating resistometer CIER CIER CI n ca erase al ages egg cna einen gre ai CI Eu aca CIER
143. THERE COBY OAD U performance qualification PQ stated value SV calibration OAD supply chemical indicator
144. jj che pan ri Su ct V ER KH Ax AE F X PCD WEF YU EOG s i gt E Pan HLO amp amp EOGIREICH LTH erility assurance level SAL nm HX
145. 4 e c 5 4 performance qualification PO OQ PQ PQ PQ PQ OQ PQ reference load zz FH vC o 1 biological indicator BI PQ Ek
146. B 7 2 4 CI A CI A 8 biological indicator BI 8 biological indicator BD 8 1 81 1 Z BI BI 29 9 29 BI chemical indicator CI BI
147. et mg HB 2 1 amp E WD 1 1 2 1 3 WD
148. ortho phthalic dialdehyde bicinchoninic acid BCA B 1 5 1 2 1 E WD hoy ROHL E E OPA Bradford dk 200zg 200xg 2 1 5 CHES Te eibi 3 3 3 1 i 3 1 1 0 1 2
149. 5 3 BBHEKUERIZA Z2 AHBBRT A HYY ONI BI mg HB 5 B 5 1 7 chemical indicator CI BI 3 1
150. EK 124F 5 H MOS ae 2005 DRE 2003 7 30 2005 5 27 80 A 2005 E
151. A 2 HL A G 9 1 1 A 3 A 4 B 1 2 2 A
152. l 2 Eze E BE PE ae 4 4 4 Ci gt ay e IO gu ZEX installation qualification H EOG GRE X MM B gt H tac Xu ASEH HE E EAH E RATA m
153. 1 BI CI 3 5 NEE ze Tid w A 2 1 COP 3 1 1m 1 3m 3 f 3 1 4
154. 2 1 1 ISO 9000 LBL 1 2 1 2 1 2 WD 2006 4 WD
155. 2005 ISO 11140 1 1 1 2 bea AiR mu ee 3 3 4 4 DX TICE St 5 5
156. 3939 VIE UE EAE AIS gt 1 AM fobs m B 11 a 11 2 amp 11 2 1 RADE A
157. LOSE 4 OMA AO 5 M oH oH 3 EOG CI EOG EOG 4 y OD X 134 3 5 30
158. 6 1 6 1 1 1 1 HR 2 S m iS d zu 6 1 2 1 2 material safety data sheet MSDS
159. CLARAE Anti B Ly HE EAS U T PEDSHEPR Ta che HE EJ
160. WD A 2 2 5 A 2 2 6 WD B 1 amp IE calibration y 2 am B 2 instalation qualification IQ WD A 3 operational qualification OQ IQ WD
161. 5 1 4 A mo TA erg fs FE i 43 4 X235 5 fA Sav T JW d RESI WATT AT iA DD or
162. Ba 1 1 1 2 amp A BI CI A B 1 2 1 1
163. nn E Eel ar HZ o OD i E FE D E BP CHS T CI 1 xn BEO
164. X Wizet k OV A Lae ARR TEL Bea NCD ad a CFESA Cee He Al DA WEH W EZ EC Hee TE EL A SB E i D TIR DKA A E A rie Ha JL IRE JD E de EY 9B WE LEEDS Kr EA mg HB 2 2 washer disinfector WD
165. 121C 15 126C 10 134C 3 3 2 115 118 C 3047 121 124 C 154 126 129C 10 2 1 steam dryness fraction 1 95 eT JE ISO TS 17665 2
166. B 2 A fn 2 He ES 1 2 4 1 BETS A 2 A
167. 4 10 biological indicator or Wrapper 4 8 AAMI ST41 PCD ANSI AAMI ST41 2008 4 4 9 AAMH PCD PCD 4 10 PCD 4 4 8 BERK 10 11 10 4 4 1 9 1
168. MONIS OCH 3 1 2 BER ROR 1 DAE Bt S 3 2 Xj zu U ze i 3 1 3 2 T 3 1 ISO TS 17665 2 3 2 3 1 3 2 3 1 ISO ISO TS 17665 2
169. 1 PO 2 PO PO BORA EOG process challenge device PCD Instrumentation AAMI PCD 2 AAMI BI SAL 10 PCD Association for the Advancement of Medical p BI PCD
170. washer disinfector WD log reduction logio reduction H D 10 D value 1 909 traceability 80 95 C thermal disinfection tt RKA INFY bioburden biological indicator BD
171. 51 12 1 12 SA ne RI 3 12 1 2 12 1 12 2 9 12 1 12 2 10 0 3 5 3 6 0 1 1 000ppm 20
172. 107 60 0 55 107 72 0 3 5 3 6 0 1 1 000ppm 1 H cf i SN 12 2 12 uum ow qut 7 z 12 1 CFU 9279 4M 0 30 1 2 5 10 20 30 1 2 3 6 0 3
173. BOG B 1 2 3 REY A ee t EL NUS A 1 B A
174. 1 2 5 SAL PEBEIRO OWTADTEDSMERERC e 5 IL LUIS B 1 2 6 1 installa tion qualification He A W FR EE 2 operati ional qualification OQ QELE COR sr A 3 perf OQ 1 2 5 UK tB Bei QD E ormance qualification PQ HALE OR 1 2 7
175. chemical indicator Cl 3 3 3 1 3 REH 1 St 0c Ti l l D 12 2 He 9 He ER
176. BI PQ PQ 5 PO BI PQ PQ 5 2 BI 2
177. 2 3 4 CI BL CI BI ffi 3 1 9 ft 4 T11 TRE OO BEA 10 REYR 35 110 WOO URS in E 33 OTK BAUS Ha velo 3 1 9 1 1 BRA iX ETER E IH
178. B 4 RAD A T 7 chemical indicator CI 7 chemical indicator CD 7 1 a 7 1 1 1 Clik NEUE XOU CI biological indicator BI 8 9D 10 10 sterility assurance level SAL CI SAL
179. 2 A 3 A tA 3 AK A Xp 3 operational qualification OQ 1 2 6 2 OQ A B 4 performance qualification PQ 1 2 6 3 PQ _ da CORRE Saute E X CIRE REI O EXE AT A HELI 517 0 PQ 5 A E IQ OQ PQ B Pal
180. Alas 2 act RN h yu it ax XE THELA C MAL E TIENT A Z l me 2 instalatio 1 DER LEA n qualification IQ OEE Da fie BS OIA aN ue
181. 2 3 4 3 1 2 3 4 4 5 6 JIS JIS 1 2 3 4 5 134C 6
182. AA Da WO LICKS VAR e o TR V e 9 UC 7 9 RA lt Al BEY 9 1 6 1 ki R eg ates 8
183. Hw E CLAY ie TAR ROKE mK EE E 1 1 ROEE i ke X 36 VE 1 id cd H 1 HU Er 3
184. 2 3 4 ope 3 rational qualification OO 1 IQ 2 OQ wi
185. 9 TUS AN P BE performance qualification E PQ AR RDM UR Be FE EZ gt H I X air KE
186. B 1 BI reference load PQ BI PQ 2 BI PQ BI PQ
187. lt E 27 30 BI PW Y aA KOORE biological indicator BD
188. A 3 EOG A 3 operational qualification OO 1 2 6 2 OQ IQ A 4 performance qualification PQ 1 2 6 3 PQ IQ OQ SAL B 5 IQ OQ PQ B 4 4 2 7
189. Beara 5 JF Si c BADE EOGOA 2 OQ IQ oe s Rog CRECE EROR jc FIZ E operational qualification OO BLU PH bat 5 1
190. EO 0mg L CI 7 chemical indicator CI 7 4 6 SV 0 SW 4 0 SV 6 SV 1 70 SV 0 SV 0 CT SV 0 gt 30 RH SV 10 SV 2 SV 15 gt 30 RH 1 CI 2 CI SV stated value 7 1 3 CI 1 CI 5 3 AA 6 4 5 6 2
191. 2008 Recommended Disinfection and Sterilization Guidelines Infect Control Hosp Epidemiol 2007 28 2 146 155 E Cooper K Breckon Sterilization bleach Journal of Hospital Infection 2005 59 379 381 2 2002 Vol 7 Nol p 29 38 2 2003 Vol 73 No3 p 114 123 3 2008 Vol 78 No7 p 433 445 Danko LH et al A Nationwide Survey of Sterile Supply Processing and Distribution SPD Services within Department of Veterans Affairs VA Medical Facilities American Journal of Infection Control 2006 Vol 34 No 5 E28 E29 Edwin S Ross Using Biological Monitoring to Reduce Infection Risk and Cost Surgical Service Management 1998 4 7 37 41 Rutala WA Weber DJ Chappell KJ Patient injury from flash sterilized instruments Infect Control Hosp Epidemiol 1999 20 458 SE 1999 Vol 4 No2 p 8 10 Gorman SP Scott EM Russell AD Antimicrobial activity uses and mechanism of action of glutaraldehyde J Appl Bacteri
192. B A B A A A 13 EK A
193. 17 12 22 1222001 1 A 3 A 13 2 2 1 13 2 1 1 A 2 13 2 1 2 A 3 A A tA 103 A B
194. EOG BI 8 biological indicator BD 8 1 BI ISO 11138 1 2 3 EOG TEE DR Geobacillus stearothermophilus Bacillus atrophaeus 1 0X105 CFU 10X10 CTUM D 121 C 5 54 C 12 5 30 C EO 600mg L 60 RH D X log 2 D X log 2 D X log 4 D X log 230 4 Z 6 CHE 8 1 3 BI BI BI 2 un qq uu c Ics diae 8 1 4 BI process challenge device PCD
195. He 4 BI 3 ES gt RH PCD EOG D 1 13 105 CFU BI BI 10 CFU BI Fr OBI f amp FH UC Ep OO S XE DS AT A L HX TRER E fal LEE CER AA 1 1 5 2 Qed 11140 1 5 xk a ae ZCANT 4 5 6 CI lt
196. 3 2 7 1 2 7 3 2 8 1 10 Cf 2 10 IT zz Sy zz OY 3 2 9 1 1 A 2 A 3 A 4 BR B
197. 9 CI BI BI 9 2 CI 3 CI stated value SV CI 9 Ea zu T S gt 7 1 2 XH CI ISO 11140 19 1 6
198. 9 1 5 En L 1 BAT AS ADAG CHS mE tie enue 2 Lm a ie JE L MX oe 4 5 6
199. Cx COREE zu l HX F process challenge WEH ZPE 4 BOG 1 EOG EOG SE EOG
200. E 104 13 EU FZ Jy FIZA VT YAE ROUNE 2 IE it 1 i PS
201. BI CI BI CI 5 4 BI 5 5 5 CI 5 1 8 t 4 10 11 10 BER WO 5 1 9 1
202. RRA ME nad HX WA 6 EX 2 WA LTE a 3 T Al 4 1 H 7g
203. 2 uli 2 1 7 1 2 1 5 WD 1
204. A 7 2 2 CI A A 7 2 3 1 CI CI CI A CI 2 CI CI B 3 B HTS A 3
205. JIS C 1010 1 2005 2 3 4 5 6 electro magnetic compatibility EMC JIS C 1806 1 4 7 8 9 2 BEAT i ES ES i YES H 3 He Da ES 5 6 1 1 J 2 DRE HE
206. 4 1 5 RARE ORE Ci aS EOG 1 1 2 amp IE calibration omui uu 3 4 1 6 PCD PQ 1 4
207. 5 9 FORE PRESQUE LV ABER LY 10 2 0 3 9 100 12 45 2 5959
208. No 9926 K K 12 6 12 6 3 W W WP 1 A 9 Abo CORA 0 1 1 000ppm 1 2
209. REHE CVD f
210. R8 BB RSS R8 X X min min EE XX EE 3 3 1 4 performance qualification PQ PQ sterility assurance level SAL PQ IQ OQ ey 1 PQ
211. 2 amp IE calibration 3 PQ 4 MORE
212. A 3 operational qualification OQ IQ A 4 performance qualification PQ IQ OQ sterility assurance level SAL B PQ Di SAL E CI BI B 5 IQ OQ PQ L B
213. ISO 15883 A QA A F 80 CLC A F A CORR 2 1 A INFECTION CONTROL 2009 2009 141 142 ay
214. performance qualification PQ PQ 1Q OQ WD WD 1 p22 A 2 1 5 2 p22 B 3
215. 1 6 7 7 chemical indicator CD NCG Ch 8 9 process challenge device PCD
216. 2 4 5 6 RO 2 WD ww 248
217. 2010 12 D ae 2000 LOTO 2000 20 5 1 21 1999 11 2000 3
218. A BI PCD A 1 BI Geobacillus stearothermophilus NTCC 7953 BI 1 1 B Geobacillus stearothermophilus ATCC 7953 BI FATS A BI A 2 EOG BI Bacillus atrophaeus ATCC 9372 BI B BI A 3 BI Geobacillus stearothermophilus ATCC 7953 BI 1 1 B 4 BI Geobacillus stearothermophilus ATCC 7953 BI 1 8 2 2 BIO
219. CY 2 2 1 Ao er 12000 a aS E XH ise a Am 19 ec 15 A At TC D Z D 10 1 Z D 10 A Z 10C TC A 80C AA AA 10 9972 A t 10T80 10 At 65 65 AA A Ag AAg D107 At 10 OC At
220. CI A 1 PCD PCD 3 4 3 4 AAMI PCD 16 PCD PCD 1 BI 1 BI 1 BI HEL LTE H BI BI E
221. Geobacillus stearothermophilus ATCC 7953 BI BI COR BI BI BI D D 12 12 D 23106 12 12 log SAL 10 ER 2 if 1 H BY 9B D D 10 CFU RR AD ATA Yc
222. m CERT D Bell American Hospital Association AHA 4 1 5 XE 1 amp IE calibration an4 MRE X Bell WSO PRA PERE 2 HE X 1 A LPR EL 2 HK EH 3 3 1
223. operational qualification OO 1 2 p22 A E E E 3 2 5 OQ OQ mg HB 2 3 p22 B
224. 5 1 KASS EIERNE Z bop 5 1 5 1 2
225. EA EOG DI E 4 3 60 C 8 50 C 12 37C 32 36 EOG E 4 3 Association for the Advancement of Medical Instrumentation AAMI 4 1 6 4 1 4
226. 3 2 2 1 A 2 CD O 1f ere B 3 2 3 1 A A 2 B 3 A 4
227. B 1 v B 2 B 13 2 3 1 A 2 1 S5 BS A
228. 4 3 BI ANSI AAMI ST41 2008 oO Oral airway 10 inch latex tubing Two 24 x 24inchi wrappers 4 4 PCD ANSI AAMI ST41 2008 4 5 PCD ANSI AAMI ST41 2008 4 4 4 24 5cm 10 58 8cm X 58 8cm 24 24 2 5 4 5 4 4 4 3 BI 2 Cle Bd4 200 fr 0 BATE FIN I A V2RCCE Fictx te 6 4 6 PCD 4 ak n i LN TROECO 4 6 PCD ANSI AAMI ST41 2008 7 4 7 PCD PCD BI CI d a 80 100 cubic foot chamber volume 4 7 a PCD 2 300 2 830L ANSI AAMI ST
229. EOG BEOG EOG EAN EVER db BOC H e EOG E 2 EOG 3 EOG E
230. 2 1 BE it 2005 2 WD 4 WD ISO 15883 WD WD
231. 60 i PCD BN 0 amp Lam AE 2mm MS OQKIC IMS HET SH 0 5mm PTFE 60 NT TE pc sk aS ye he ISO 17665 1 2006 PCD a ISO PCD ISO TS 17665 2 2009 1 5m AE 2mm HS ANS KARER CT EN 867 5 2001 0 5mm PTFE EOS ERRUER CL 1 1 7 1 1 1 F
232. 7 0 0 0 0 0 0 0 0 0 3 T NT NT NT L 1x102 46 8 0 0 0 0 6 2 x 10 0 55967 4 7 Jv NT NT NT NT 1 8x102 92 96 96 100 30 92 0 1 Na NT NT NT 8 0 0 0 0 0 0 0 3 1 3X10 3 6X 10 0 0 0 0 0 0 0 0 3 T NT NT NT L0x10 7 8X10 5 0x10 6 4 0 0 4 7 X 104 559 T NT NT NT 42X10 1 6X10 5 0X10 5 8X 10 4 610 4 8108 9 4 10 1 Na NT NT NT NT 5 8X 10 0 0 0 0 0 3 1 3X106 2 6X105 1 3103 0 0 0 0 0 0 0 3 T NT NT NT 2 5X10 1 3X106 1 0X10 3 8x 10 8 2 0 1 0X10 559 NT NT NT NT 44X109 3 9X106 2 2X106 4 2X106 1 9X106 3 8X106 4 0X107 1 Na NT NT NT NT 13x10 0 0 0 0 0 0 iM EH 7 x 12 2 0 19 Po CFU 22 0 30 1 2 5 10 20 30 1 2 3 6 3 2 9X102 8 0 0 0 0 0 0 0 0 3 NT NT NT NT 2 7 X 102 26 2 0 0 0 6 2X 102 559 T T NT NT 6 7X10 3 0X102 3 1X10 2 7X10 1 6xX10 1 7X10 4 2x10 1 Na T T NT NT 4 2 10 6 0 0 0 0 3 8 8 X 108 42 0 0 0 0 0 0 0 0 3 T T NT NT 3 9X104 2 3X10 1 8X102 2 0 0 4 7 X 104 559 T T NT NT 4 4X1
233. ux EAR AA 7 1 pal 4 n bd CI TIAS 22744 FFAS 6 LV PCD 1H PCD CI 5 AAMI 2 4 5 6 HCI 7 1 CI 80 7T chemical indicator CI 2 CI
234. 2010 2010 12 1 2 2011 3 1 3 2011 11 25 113 0033 3 39 15 03 3813 1062 FAX 03 3814 3837 URL http www jsmi gr jp p
235. Mr 5 mg HB 5 2 9 1 A 2 amp IE calibration B 3 1 B 2 A T 6 6
236. 1 CI 2 CI SV stated value 7 3 5 12140 5C 135 0 5C 2 128C 3 121C 16 5 12140 5C 135 0 5CKLU 2 63 6 CI 6 14 0 9 137 138C 3031 54 0 5 C 600 30mg L 60 106RH 30 v 37 0 5C 600 30mg L 60 10 6RH 90 66 7 CI
237. 3 Su gt Ax KE REWON a AS EOG 4 BEOG AY 0D lla BE A CARER CR OLD RAMIREZ RET A Su Ax AE
238. 4 5 6 CI JHE 8 1 4 8 2 1 7 1 4 gt Nes 4 ISO 11140 1 4 5 6 CI ISO 11140 1 1 CI 17 1 3 CI 7 1 4 2 1
239. 70 80 2 60 1 2 1 5 1 DJ 2 iF 40 60 3 2 1 5 1 3 4 90 93 5 10
240. lt DICK OD IESETE2MBZg ovv e L6 BI RAAKA DA 299 8 1 5 BI 8 1 6 BI BI 121 C 15 134C 3 82 8g amp 8 2 1 BI BI BI
241. pa PERE H 1 E gt HZ Ys A A M su HE JE E ONE WX orl PA N JW LER Re 5 H px A ERAI CAR KIRARA 1 i 3 F 4 He bal ix Aj te M D A 3 2 3 2 1 1
242. BI ISO 11140 11 cB 1 CI BI BAI umm C Ped HAL 1 CI 1 1 6 process challenge device PCD PCD ISO 111399 PCD PCD PCD AAMI PCD 66 GR Fl
243. 4 90 X BA Xp WEITET ARENY Pra VBU 2 ZEREMBVE Sa non condensable gas NCG E 3 FEENEY J AED 3m gt EF Lu 4 pH v
244. EOG 3 EOG EOG EOG OUR EMA SIF SRM EOG 1 2 6 1 3 30 4 6 1 1ppm 5 EOG
245. PCD a ics m 41cmX66cm 6 23cm H0 T8029 v7 ANSI AAMI ST79 2006 A1 2008 A2 2009 AAMI PCD X23cm 16 15cm 1 35kg PCD ANSI AAMI ST79 20062 23cmX30cm AAMUSEREPCD A1 2008 A2 2009 25 28cm Ee PCD 60 90cm X120cm 16 EN PCD EN285 2006 A1 2008 A2 2009 22cmX30cm 25cm OQ 7 0kg
246. RE r 1 e 3 e 4 1 2 8 ft 8 1 2 9 1 3X WA 2 3 PE ic He Alvi Dad Lie WAAI ES 4 B WE Wc A I oe COUN sien es i eg A A RES OPTIC X 0 JS A rte VH
247. disc LEE 40C 3 40C 3 0 3 10 C 0 3 10 C Uc 90 93C 5 10 0 5 40C 40 60 5 10 I 1 1 TI 1 1 0 2 75C 0 2 90 93 C i 75 C 1 90 93 5 10 110 30 110 30 70 80C 70 80C mg HB 2 1
248. 1 40 2 90 93C 5 10 3 1 2 4 70 75C m 5 IR 100 110C
249. 11 1 4 4 EOG PCD ANSI AAMI ST41 PCD ANSI AAMI ST41 2008 1 4 46cmX76cm 18 30 2 BI 2 CI 1 2 4 2 V A g Step1 Step2 Step3 a Step1 Step2 Step3 b Step1 Step2 Step3 c 4 2 ANSI AAMI ST41 2008 3 4 3 BI EOG BI 2 4
250. 1L 10 10mL d P 1 1 1 D 1 10 000ppm 6 6 ne ae MN T 5 10 10 cs T 10 10 HT 1 15 E EOG xp Uc 122 mH A B B 102 E DAT FT AVI E 34 13 W
251. 6 UR KLT IYFF be YORAM ok 3 n 2 La BERI LC 2 WD WD
252. A Lu uu B C ae H DIDI UI dd 1 1 5 2 a washer disinfector WD 12 3 23 4 ethylene oxide gas EOG 39 5 t mudlzp i Rm RFP E E 57 6 GR RR 67 T
253. 1 H BI 4 5 B A E A A 9 9 1 9 1 1 1 1 X 2
254. 6 2 5 6 1 4 6 1 5 B 1 amp IE calibration B 2 instalation qualification IQ IQ 1 A 2 A 3
255. Ei FE WS a DS DPA AC Te EAU TE 3219 ELAN y O Ke Ei 5 ISO TS17665 2 3 3 ISO TS 17665 2 RIKER SiO lt 0 1mg L gk Fe lt 0 1mg L Cd 0 005mg L Pb 0 05mg L Fe Pb Cd lt 0 1mg L CI lt 0 1mg L PO lt 0 1mg L 20 3 u S cm pH 5 7 0 02 mmol L NCG lt 3 5 v v AN 295 290 25 C hy DIR
256. SO 11137 1 2006 Sterilization of health care products Radiation Part1 Requirements for development validation and routine control of a asterilization process for medical devices ISO 11137 2 2006 Sterilization of health care products Radiation Part2 Establishing the sterilization does SO 11137 3 2006 Sterilization of health aspects SO 11138 1 2006 Sterilization of health care products Biological indicators Part1 are products Radiation Part3 Guidance on dosimetric Q General requirements ISO 11138 2 2006 Sterilization of health care products Biological indicators Part2 Biological indicators for ethylene oxide sterilization process SO 11138 3 2006 Sterilization of health care products Biological indicators Part3 Biological indicators for moist heat sterilization process ISO 11138 4 2006 Sterilization of health care products Biological indicators Part4 Biological indicators for dry heat sterilization process ISO 11138 5 2006 Sterilization of health care products Biological indicators Part5 Biological indicators for low temperature ateam and formaldehyde sterilization process e ISO TS 11139 2006 Sterilzation of health care products Vocabulary ISO 11140 1 2005 Sterilization of health care products Chemical indicators Part1 General requirements SO 1
257. WA MN dB th AF washer disinfector WD AF fuse ethylene oxide gas EOG RESI Fy a VB LON RE WE PH S fl chemical indicator CI th FREE E biological indicator BI amp th GR SE Miz 3E th T uj i J
258. 1 2 7 4 2 8 4 1 10 2 10 H Nr H Nr 4 2 9 BOE B 1 A 2 amp IE calibration B 3 PCD PQ 1 2 1 B 4
259. 1 8 1970 1971 Prevention au ERSM K Organization JCAHO ji 2 3 EX FI i ISO 11607 5 ERSM 1997 TRKI TRSM ERSM CDC time related sterility maintenance event related sterility maintenance
260. 1 f 102 8g 10 2 1 A 1 1 2 3 chemical indicator Cl 4 biological indicator B 2 3 4 5 6 7 9 1 8 8 10 2 2 3 A 1
261. 16 1 3 1 DIRE DILERA ci Xn E E UE DAIIAST TOZAAI 6 1 6 6 1 4 WEAKER k UMA 1 amp IE calibration oo H 6 1 5 iX H gt ae pines CBU Aik
262. 2000 EH FR 9 3 by 4 5 9 5 9 1 4
263. PCD HH E E BI H D Z I E A BI HT NEL CA mA 10 CFU BI E 2 5 n CI BI E ZISO OSO 11138 4 5 6 CI PCD PCD
264. 03 1 210 3 8X103 2 8X103 1 2X103 2 7X103 1 6103 1 Na T T NT NT 3 1X10 6 8 10 0 0 0 0 3 3 3X106 2 0X10 0 0 0 0 0 0 0 0 0 3 T T NT NT 9 6X105 7 9X10 5 0x10 0 0 0 0 1 0X107 559 T T NT NT 5 2X106 5 8X106 7 4X106 4 8X106 4 7X106 4 8X106 4 0X107 1 Na T T NT NT 4 7X106 4 0x 10 4 0 0 0 0 20 C NT 12 1 3 1 2 20 3 2 25 28 3 5 2 20 FRE 12 1 A EOGRE 2 d8 L7 5 MARA Zeit TUE 10 60 12 3
265. 1140 3 2007 Sterilization of health care products Chemical indicators Part3 Class 2 indicators systems for use in the Bowie and Dick type steam peneration test SO 11140 4 2007 Sterilization of health care products Chemical indicators Part4 Class 2 indicators as an alternative to the Bowie and Dick type test for detection of steam peneration SO 11140 5 2007 Sterilization of health care products Chemical indicators Part5 Class 2 indicators for Bowie and Dick type air removal tests SO 11607 1 2006 Packaging for terminally sterilized medical devices Part1 Requirements for materials sterile barrier systems and packaging systems SO 11607 2 2006 Packaging for terminally sterilized medical devices Part2 Validation requirements for forming sealing and assembly process SO 11737 1 2006 Sterilization of medical devices Microbaiological methods Part1 Determination of a population of microorganisms on products SO 11737 2 2009 Sterilization of medical devices Microbaiological methods Part2 Tests of sterility performed in the definition validation and maintenance of a sterilization process SO 11737 3 2004 Sterilization of medical devices Microbaiological methods Part3 109 Guidance on evaluation and interpretation of bioburden data SO 13408 1 2008 Aseptic processing of health care products Part1 G
266. 41 2008 4 b 40 79 cubic foot chamber volume 4 7 b PCD 1 100 2 200L ANSI AAMI ST41 2008 c 16 39 cubic foot chamber volume 4 7 c PCD 450 1 100L ANSI AAMI ST41 2008 d lt 16 cubic foot chamber volume 4 7 d PCD lt 450L ANSI AAMI ST41 2008 5 4 1 7 4 1 6 SAL 5 1
267. 9 PR i 70 mmm RN a 9 1 2 BK BAN FORMICA DET ZZ Son Pees ny _ c 9 2 3
268. BI PCD BI b 4 Geobacillus stearothermophilus 35 37 55 60 3 PCD 10515 USES W BI CI Bug ate Zi amp 5d 3 3 6 PCD ANSI AAMI ST 87 ANSI AAMI ST 799 PCD PQ vum 5 3 1 7
269. EOG 4 2 Ki 4 2 EOGHEA CHASNSR4RH 35 70 C 4096 RHEA E EOGIR HE 400 1100mg L 1 SAL biological indicator BI PCD EL BI 2 PCD 4 1 6 mone 2 EOG
270. Ze VEA UAR t OO SITE OC m bow a E m IE 2 SX 3 4 Hu 12 P aN 4 X B He 56 BE i5 Ek dA
271. e ACEH T chemical Indicator Cl 75 8 biological indicator Bl e 82 9 85 10 92 14 93 12 96 13 103 106 ISO 109
272. eneral requirements SO 13408 1 2008 Aseptic processing of health care products Part2 Filtration SO 13408 3 2006 Aseptic processing of health care products Part3 Lyophilization SO 13408 4 2005 Aseptic processing of health care products Part4 Clean in place technologies SO 13408 5 2006 Aseptic processing of health care products Part5 Sterilization in place SO 13408 6 2005 Aseptic processing of health care products Part6 Isolator systems SO 14161 2009 Sterilization of health care products Biological indicators Guidance for the selection use and interpretation of results SO 14937 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development valdation and routine control of a sterilization process for medical devices ISO 15882 2008 Sterilization of health care products Chemical indicators Guidance for selection use and interpretation of results SO 15883 1 2006 Washer disinfectors Part1 General requirements terms and difinition and tests SO 15883 2 2006 Washer disinfectors Part2 Requirements and tests for washer disinfectors employing themal disinfection for surgical instruments anaesthetic equipment bowls dishes receives utensils glassware etc ISO 15883 3 2006 Washer disinfectors Part3 Requirements and tests for washer disinfectors employi
273. illus subtilis vegetative cells and 107 48 49 spores Appl Microbiol 1989 8 p 101 104 1997 38 p 85 87 Rutala WA Clontz EP Weber DJ et al Disinfection practices for endoscopes and other semicritical items Infect Control Hosp Epidemiol 1991 12 p 282 288 50 Ayliffe GAJ Babb JR Bradley CR Sterilization of arthroscopes and laparoscopes J Hosp Infect 1992 51 52 53 54 55 56 57 58 59 60 22 p 265 269 WID 27A FRR LS ERE 1995 16 p 615 617 Jachuck SJ Bound CL Occupational hazard in hospital staff exposed to 2 per cent glutaraldehyde in an endscopy unit J Soc Occup Med 1989 39 p 69 71 Calder MI Wright PL Grimstone D Glutaraldehyde allergy in endoscopy units Lancet 1992 15 p 433 Gannon PF Bright P Campbell M et al Occupational asthma due to glutaraldehyde and formaldehyde in endoscopy and x ray departments Thorax 1995 50 p 156 159 Rideout K Teschke K Dimich Ward H et al Considering risks to healthcare workers from glutaraldehyde alternatives in high level disinfection J Hos
274. indicators Test equipment IAHCSMM Central Service Technical Manual 7th Edition ISO 11140 3 2007 Sterilization of health care products Chemical indicators Part3 Class 2 indicators systems for use in the Bowie and Dick type steam peneration test ISO 11140 4 2007 Sterilization of health care products Chemical indicators Part4 Class 2 indicators as an alternative to the Bowie and Dick type test for detection of steam peneration 106 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 ISO 11140 5 2007 Sterilization of health care products Chemical indicators Part5 Class 2 indicators for Bowie and Dick type air removal tests AORN Perioperative standards and Recommended Practices 2010 edition WRM Vol 78 No9 p 23 28 2008 Vol 29 Supplement WAI 2006 Vol 76 Nol p 21 30 Rutala WA How to Assess Risk of Disease Transmission to Patients When There Is a Failure to Follow gl
275. ng themal disinfection for human waste containers SO 15883 4 2008 Washer disinfectors Part4 Requirements and tests for washer disinfectors employing chemical disinfection for thermolabile rndoscope ISO TS 15883 5 2005 Washer disinfectors Part5 Test soils and methods for demonstrating cleaning efficacy SO 17664 2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices e SO 17665 1 2006 Sterilization health care products Moist heat Part1 Requirements for the development validation and routine control of a sterilization process for medical devices ISO TS 17665 2 2009 Sterilization health care products Moist heat Part2 Guidance on the application of ISO 17665 1 SO 18472 2006 Sterilization health care products Bioloical and chemical indicators Test equipment SO 25424 2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development validation and routine control of a sterilization process for medical devices 110 10 11 12 13 RAOK KIWARI AWWA FY a V BEU HE
276. ol 1980 48 p 161 190 Kobayashi H Tsuzuki M Koshimizu K et al Susceptibility of hepatitis B virus to disinfectants or heat J Clin Microbiol 1984 20 p 214 216 Payan C Cottin J Lemarie C et al Inactivation of hepatitis B virus in plasma by hospital in use chemical disinfectants assessed by a modified HepG2 cell culture J Hosp Infect 2001 47 p 282 287 Sattar SA Springthorpe VS Karim Y et al Chemical disinfection of non porous inanimate surfaces experimentally contaminated with four human pathogenic viruses Epidem Inf 1989 102 p 493 505 Best M Sattar SA Springthorpe VS et al Efficacies of selected disinfectants against Mycobacterium tuberculosis J Clin Microbiol 1990 28 p 2234 2239 Hernandez A Marto E Matas L et al In vitro evaluation of Perasafe compared with 2 alkaline glutaraldehyde against Mycobacterium spp J Hosp Infect 2003 54 p 52 56 BAHIA XX 2003 18 p 401 403 Rutala W A Weber D J Disinfection of endoscopes review of new chemical sterilants used for high level disinfection Infect Control Hosp Epidemiol 1999 20 p 69 76 w 2006 21 p 236 240 Bloodfield SF Arthur M Effect of chlorine releasing agents on Bac
277. p Infect 2005 59 p 4 11 Koch S Karamer A Stein J et al Investigation of mutagenicity in sperm head test mouse and mutagenic potency of 2 disinfectants on the basis of peracetic acid and phenolics Zbl Hyg 1989 188 p 391 403 Coates D A comparison of sodium hypochlorite and sodium dichloroisocyanurate products J Hosp Infect 1985 6 p 31 40 Coates D Conparison of sodium hypochlorite and sodium dichloroisocyanurate disinfectants neutralization by serum J Hosp Infect 1988 11 p 60 67 17 12H 22H 1222001 17 12 22 1222001 5 PRI 108 ISO ISO 10993 7 2008 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals SO 11135 1 2007 Sterilization of health care products Ethylene oxide Part1 Requirements for development validation and routine control of a sterilization process for medical devices e ISO TS 11135 2 2008 Sterilization of health care products Ethylene oxide Part2 Guidance on the application of ISO11135 1 e
278. p ui DU BE cum 4B B gt Kus H X mm UT WK EK o fL al WAT e E EH pu
279. ppm CHS Moldex 2400 K K 51 K K 12 5 2 14 50 2 2 25 7 10 3 21 28 12 5 Moldex 2400 GE 51 F 2 1 0 3
280. products Vocabulary ISO 15882 2008 Sterilization of health care products Chemical indicators Guidance for selection use and interpretation of results EN 285 2006 A1 2008 A2 2009 Sterilization Steam sterilizers Large sterilizers ISO 17665 1 2006 Sterilization health care products Moist heat Part1 Requirements for the development validation and routine control of a sterilization process for medical devices ISO TS 17665 2 2009 Sterilization of health care products Moist heat Part2 Guidance on the application of ISO17665 1 EN 867 5 2001 Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S EN 13060 2004 A1 2009 A2 2010 Small steam sterilizers TALI ZR AIC 3SU 22EBET ERIS 2002 Vol 72 No 9 p 423 428 pH 2002 Vol 72 No10 p 529 530 ANSI AAMI ST8 2008 Hospital Steam Sterilizers CDC Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 BAEOURA KMR CDC fai 2008 ISO 18472 2006 Sterilization health care products Bioloical and chemical
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