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- えみ しろみず
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1 ZENTRAL STERILIZATION International Journal of Sterile Supply 2 DGKH German Society for Hospital Hygiene DGSV German Society of Sterile Supply AKI Working Group Instrument Preparation 1
2 EN ISO BCA EN ISO A
3
4 1. MD Sozialgesetzbuch Infektionsschutzgesetz [IfSG] 4
5 Medizinproduktegesetz MPG Medizinproduktebetreiber verordnung MPBetreibV 4 2 Grund-sätze der Prävention BGV A1Employers Liability Insurance Association BGR/TRBA250 TRBA TRBA 2.2. RKI RKI BfArM EN ISO DIN EN ISO EN ISO EN ISO MPG 5
6 ISO/TS EN ISO EN ISO EN ISO IQ OQ 6
7 PQ IQ OQ PQ 7
8 EN ISO IQOQ PQ
9 RKI EN ISO EN ISO EN ISO MPG CE IQ BQ PQ 9
10 1 EN ISO
11 EN ISO
12 A B C D A EN ISO B C B D 12
13 B C D A A 2 3 BCA 13
14 B C D A > 200 g > g 100 g B C > 200 g > g 100 g D
15 ±20% rpm ±5 rpm ± 5 K 15
16 EN ISO , point A 0-0/+5 K A 0 2K A 0 5 EN ISO A 0 ±2.5 K
17
18 1 18
19 ph 19
20
21 A EN ISO DIN EN ISO
22 8. Carter, A. DGSVKrüger, S. DGKHSchmidt, V. AKI Dr. Bobyk, D. DGKHEibl, R. AKIProf. Dr. Heeg, P. DGKHJones, A. DGSV Dr. Kober, P. DGKHProf. Dr. Kramer, A. DGKHDr. Linner, M.-Th. DGKHProf. Dr. Martiny, H. DGKHDr. Michels, W. AKIRoth, K. AKIWeitze, W. AKIProf. Dr. Werner, H.-P DGKH 22
23 9. 1 IQ OQ PQ EN ISO IQ OQ PQPRQ 3 4 ISO 9001 ISO RO 4.1 MPGMPBetreibV DGKH DGSV AKI 23
24 II DGSV 4.2 I TSA ISO 9001 ISO
25 25
26 2 1 Crile arterial clamps 1 Acila GMN Möhrfelden 10 1 ml 1.5 IU Acila GMN 100 ml PCD PCD 2.1 PCD
27 0.5% Miele G % Miele G 7735 OPA PCD SDS OPA % % Vario TD Miele 2.4 PC 5 27
28 A %SDS 60 1%SDS ph ml C123.1 Carl Roth GmbH, Karlsruhe 2 ml SDS 2 ml 4 28
29 Central Service %SDS 60 SDS ph11 ph 0.5pH ph 1%SDS 5ml 2-5ml SDS 2ml SDS
30 BCA SDS 1ml SDS 200µg 100µg 1ml µg 30
31 3BCA 1 Biuretcarbamoyl urea bi ureturea II 6545nm SDS SDS mg/ml 500 µg/ml BCA µg BCAbicinchoninic acid (II III(I BCA 562nm II BCA 7 60 C C 2 BCA Pro-tect M Konica Swab N Check SDS SDS Pierce BCA VWR 8 BSA
32 µg/ml 60 C 30 SDS Miele BCA (II) A SDS 1ml II 6 II 6 7 II BIBCA C 2 7 II I BCA III I BCA 3 BCA BCA SDS BCA 32
33 4 EN ISO dh 0.5 mmol CaO/L 500 mg/l 100 mg/l ph 5 8 EN ISO EN285 B B1 15 S/cm ph mmol CaO/L 10 mg/l P 2 O mg/l SiO 2 1 mg/l 2 mg/l 33
34 5 EN ISO A 0 F DIN EN ISO15883 A 0 65 C D A A 0 D 80 C z C D 1/ /10 90 A0 = 10 (T-80)/z t A 0 z 10 C t T PC A 0 65 C 65 C z D 55 C A 0 A 0 A 0 34
35 A B A A B A A A Federal Health Gazette A A 0 A 0 A , , , ,000 35
36 6 93/42 2 vcjd ph 10 Federal Health Gazette Bundesgesundheitsblatt
37 5-10% 3 ml/l vol. 37
38 7 DIN EN ISO DIN EN ISO
39
40 DIN EN ISO SOP DGSV 40
41 EN ISO
42 2 1 No. 1 2 MPBetrerbV No. No. No No. 2 42
43
44 SPECTARIS 1/3 No /+5 44
45 SPECTARIS 2/ g/l 2 g/l 3 g/l 4 g/l 4. 45
46 SPECTARIS 3/
47 1 2 rpm * 47
48 2 48
49 2 DIN EN ISO A B 1 mm 3 mm 5 mm 10 mm
50 IfSG 2 18 BGA 1 1 German Federal Health Office 2 50
51 8.1 DIN ph ph functional part 3 51
52
53
54 µg >100µg - 200µg >200µg µg >100µg - 200µg >200µg µg >100µg - 200µg >200µg
55 µg >100µg - 200µg >200µg µg >100µg - 200µg >200µg µg >100µg - 200µg >200µg
56 EN 18O
57 10 57
58 15µS/cm 58
59 11 [] 1 A 0 1a 1b 1c 1d 2 2a 2b 2c 3 3a 3b 3c 4 4a 4b 4c [] 59
60 1 A 0 1a-1d 1a 1b 1a 1c 1a 1b 1d 1a-1c 60
61 2 2a-2c 2a 2b 2a 2a 2c 3 3a-3c 3a 3b 61
62 3a 3c 4 4a 4b 4c 62
63 ,9 IT
64 DIN ISO EN ISO DIN DIN EN ISO
65 Spectaris
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More information滅菌 International Journal of Sterile Supply ( 滅菌事業に関する国際機関紙 ) 補足 1 耐熱性医療機器の自動化洗浄殺菌工程に関するバリデーションおよび定期的監視の ガイドラインと洗浄殺菌装置の選定に関する助言 DGKH German Society for Hospital Hygiene( ドイツ病院衛生協会 ) DGSV German Society
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