I GB Performance criteria for microbiological safety cabinets ( ) - - - -
II...II... IV 1...1 2...1 3...1 4...2 4.1...2 4.2...2 4.3...3 5...4 5.1...4 5.2...4 5.3...4 5.4...4 5.5...5 6...7 6.1...7 6.2 HEPA...7 6.3...7 6.4...7 6.5...7 6.6...7 6.7...8 6.8...8 6.9...8 6.10...8 6.11...9 6.12...9 6.13...9 6.14...9 7...9 7.1...9 7.2 HEPA...9 7.3...9 7.4...9 7.5...9 7.6...9
III 7.7...10 7.8...10 7.9...10 7.10...10 7.11...10 7.12...10 7.13...10 8...10 8.1...10 8.2...10 8.3...11 8.3...11 9...11 9.1...11 9.2...12 10...12 10.1...13 10.2...13 10.3...13 10.4...13 A...14 B...33...35
IV EN12469:2000 NSF/ANSI49-2002 Class A B ESCO
1 Performance criteria for microbiological safety cabinets : 1 MSC, / 2 GB 4793.1 EN 292-1 EN 292-2 [1] [2] [3] GB/T191-2000 GB/T 1184-1996 GB 4793.1 GB 4793.1-1995 1 [1] GB 13554-92 GB19489-2004 3 3.1 microbiological safety cabinet(msc) 3.2 biological agents 3.3 biohazard 3.4 biohazard levels 4 1 2
2 3 4 3.5 cross contamination 3.6 product protection 3.7 working area 3.8 positive 3.9 negative 3.10 downflow air HEPA 3.11 inflow air 4 A1 A2 B1 B2 4.1 1 2 3 4.2 1 2 3
3 A1 A2 B1 B2 4.2.1 A1 0.38m/s A1 4.2.2 A2 0.50m/s A2 4.2.3 B1 0.50m/s B1 4.2.4 B2 0.50m/s ( ) B2 4.3
4 1 2 3 4 120Pa 0.7m/s 5 5.1 5.1.1 5.1.2 5.1.3 5.2 a) 160mm~250mm b) c) d) e) e) 8 5.3 5.3.1 GB/T1184 5.1.1 L 5.3.2 0 1 mm 5.3.3 GB/T1184 12 5.4 5.4.1 5.4.2 300 5.4.3 5mm
5 5.4.4 5.5 5.5.1 a) b) c) d) e) f) g) 3mm 6mm h) 5.5.2 5.5.3 5.5.4 a) HEPA GB13554 B b) HEPA GB13554 C HEPA C HEPA c) 5.5.5 50% 10%
6 5.5.6 a) 1.15 b) 5.5.7 -- 5.5.8 a) III b) 4000ml c) 5.5.9 5.5.10 5.5.11 a) b) 5.5.12 5.5.12.1 5.5.12.2 / 5.5.12.3 B B 15 20% 5.5.12.4 A1 A2
7 A1 A2 5.5.13 5.5.14 HEPA 6 6.1 500 30min 450Pa 500Pa 10% 30min 6.2 HEPA 0.01% 0.005% 6.3 57dB(A) 67dB(A) 57dB(A) 67dB(A) 6.4 650lux 110 50lux 430 lux 6.5 10Hz 10kHz 5µ m(rms) 6.6 6.6.1 1 8 10 8 5min 6 10 CFU 5 CFU 6.6.2
8 1 10 6 8 10 6 min CFU 5 CFU 6.6.3 1 10 4 8 10 4 min 360mm 360mm 2 CFU 6.7 6.7.1 0.25~0.5m/s 6.7.2 ±20% ±0.08m/s 6.7.3 ±20% ±0.08m/s 6.7.4 5.5.5 ±0.025m/s 6.7.5 m 3 0. 05m 3 /s 6.8 6.8.1 0.7m 6.8.2 A1 0.38m/s 6.8.3 A1 0.067m 2 /s 6.8.4 A2 0.5m/s 6.8.5 A2 0.1m 2 /s 6.8.6 B1 B2 0.5m/s 6.8.7 B1 B2 0.1m 2 /s 6.8.8 6.5 ±0.025m/s 6.8.9 0.7m/s 6.9 6.9.1 6.9.2 6.10 1h 4000ml
9 6.11 6.11.1 10 6.11.2 110kg 2mm 6.11.3 23kg 6.11.4 110kg 1.6mm 6.12 4 8 6.13 120Pa 6.14 GB 4793.1 7 7.1 A.1 6.1 7.2 HEPA A.2 6.2 7.3 A.3 6.3 7.4 A.4 6.4 7.5 A.5 6.5 7.6 7.5.1 A.7.3 6.7.1 7.5.2 A.7.4 6.7.2
10 7.5.3 A.7.5 6.7.3 7.7 A.7 6.7 7.8 A.8 6.8 7.9 A.9 6.9 7.10 A.10 1h 6.10 7.11 7.11.1 A.11.3 6.11.1 7.11.2 A.11.4 6.11.2 7.11.3 A.11.5 6.11.3 7.11.4 A.11.6 6.11.4 7.12 A.12 6.12 7.13 A.13 6.13 8 8.1 1 8.2 2 a) b)
11 c) d) e) f) 1 8.3 1 8.3 1 1 9 9.1 6.1~6.5, 6.7~6.14 6.1~6.14 6.1~6.5, 6.7~6.14 6.1, 6.2, 6.6~6.9 9.1.1 a) b) c) d) e) f) g) h i) kw r/min j)
12 k) l) m) 9.1.2 1 9.2 1, GB191-2000 : a) b c d) e f g GB/T191-2000 10
13 10.1 10.1.1 10.1.2 8.2 10.2 10.2.1 10.2.2 10.3 10.4 9.1 80% 40
14 A 0.015m/s A.1 A.1.1 A.1.1.1 A.1.1.2 a) 0-600Pa 5Pa b) 25g/L A.1.1.3 a) b) c) A A1a d) 500Pa 30min 10% 500Pa A.1.1.4 a) b) c) d) 500Pa 10% e) A.2 HEPA A.2.1 HEPA HEPA B1 HEPA 0.015m/s A.2.2 DOP - PAO (2- )
15 A.2.3 a) 100% 10 g/l 1 10-3 % b) 0-550 kpa 7kPa A.2.4 140kPa DOP 25mm A.2.4.1 a) A1/A2 B2 HEPA b) c) HEPA 10 g/l DOP d) 25mm 50mm/s HEPA A.2.4.2 10mm A.3 A.3.1 0.015m/s A.3.2 50-100dB 1dB 1dB A A.3.3 a) b) A
16 c) 300mm 380mm A A1 d) c) e) 57 db(a) db(a) 0-2 3 3 4-5 2 6-10 1 >10 0 A.4 A.4.1 A.4.2 10% 1000lux A.4.3 a) 300mm 150mm A A2 b) c) A.5 A.5.1 0.015m/s A.5.2 2.5 m (rms) A.5.3 a) A A3
17 b) c) d) A.6 A.6.1 30min A.6.2 A.6.2.1 No.9372 1 No. 10073 2 B A.6.2.2 a) 100 x 15 mm 150 x 22 mm b) 12.3 12.6L/min 20ml c) 28 1.4L/min d) 1) 5min 1 10 8 ~8 10 8 2) (94±6)% 3) (0.50±0.05)m/s e) 63mm A.6.3 1 10 8 ~8 10 8 5min A.6.3.1 A.6.3.2 a) 55ml 5 10 8 ~8 10 8 /ml 350mm 100mm A A4 b) 150mm 70mm A A5 c) 6 2
18 150mm 63 mm 2 50mm 25-30mm 63 2 360mm 50mm 150mm A A6 A7 d) 2 150mm 200mm A A7 e) 10mm A A5 f) 30min min 0 5 6 11 11.5 30 g) 47.0mm 0.22µm 37.0 24-28h 44-48h 300CFU A.6.3.3 a) -0.050±0.015m/s +0.050±0.015m/s A.6.3.2 b) -0.050±0.015m/s A.6.3.2 A.6.4 1 10 6 ~8 10 6 5min A.6.4.1 A.6.4.2 a) A A8 b)
19 150mm 70mm A A9 c) 55ml 5 10 6 ~8 10 6 /ml 100mm A A9 d) 10mm A A9 e) 5min f) 37.0 24-48h 44-48h A.6.4.3 +0.050±0.015m/s -0.050±0.015m/s A.6.4.2 A.6.5 1 10 4 ~8 10 4 5min A.6.5.1 A.6.5.2 a) 55ml 5 10 4 ~8 10 4 /ml 76-130mm A A10 b) A A10 1) 2 360mm 3 360mm 1 2 c) 5min d) 15min 37.0 24-28h 44-48 e) b) d) A.7 A.7.1 A.7.2 a) ±0.015m/s ±3%
20 b) A.7.3 A.7.3.1 100mm A A11 a) 150 150mm 3 7 b) 150mm A.7.3.2 100mm A.8 A.8.1 A.8.2 a) ±3%±0.002m 3 /s b) ±0.015m/s ±3% c) A.8.3 A.8.3.1 a) b) 5 c) m 3 /s m 2
21 m/s d) m 3 /s m m 2 /s e) A.8.3.2 10 A.8.3.2.1 a) 100 100mm 100mm A A12 b) c) m/s m 2 m 3 /s d) m 3 /s m 2 m/s e) A.8.3.2.2 a) 25% 75% A A13 b) 100mm 100mm A.8.3.2.4 B2 a) b) c) ASHRAE 5 d) 150mm 100 100mm A A14 m 2 m 3 /s
22 e) / / f) / g) A.8.3.3 1min A.9 A.9.1 A.9.2 A.9.3 A.9.3.1 100mm A.9.3.2 25mm 150mm A.9.3.3 38mm A.9.3.4 50mm A.10 4000ml 1h 1h A.11 A.11.1 a) b)
23 c) d) A.11.2 a) ±5% b) 23kg 250 250mm 110kg c) A.11.3 10 A.11.4 a) b) 110kg 250 250mm 110kg 250 250mm A A15 A16 A.11.5 a) b) 23kg A A17 A.11.6 110kg A A18 A.12 A.12.1 1 C A.12.2 80mm A.13
24 A1 A2
25 A3 A4
26 A5 A6
27 A7 A8
28 A9 A10
29 A11 A12
30 A13 A14 B2
31 A15 A16
32 A17 A18
33 B B.1 ATCC9372 1 NCTC10073 2 B.2 PBS 1) 34g KH 2 PO 4 500ml 1N NaOH ph 7.2 0.5 1000ml PBS 2) 1.25ml PBS 1000ml 120 15min PBS 5.0mlMgSO 4 MgSO 4 1000ml 50gMgSO 4 7H 2 O 1000ml 25 ph 7.0 0.1 120 15min 4 B.3 A a) (Difico 1 ) 100 15mm b) 37 0.5 48 2h c) 10 220ml 50ml d) 37 0.5 48 2h, e) 10ml PBS f) 150ml 100ml 65 0.5 15min PBS 2500rpm 15min PBS g) PBS 3 2~4 10 9 /ml ; h) 37 0.5 48 2h, i) PBS 5 10 8 ~8 10 8 /ml j) 4 2 10 9 ~4 10 9 /ml -70 4
34 B a) 250ml b) 37 0.5 48 2h c) 65 0.5 15min d) 2500rpm 15min 3 PBS e) PBS 1.5 10 9 /ml f) 37 0.5 48 2h g) PBS 5 10 8 ~8 10 8 /ml i) -70 4
35 [1] GB/T 1184-1996 [2] GB 4793.1-1995 1 [3] GB 13554-92 [4] GB19489-2004 [5] ISO 15189:2002 Medical laboratories Particular requirements for quality and competence [6] ISO 15190:2003 Medical laboratories Requirements for safety [7] American Type Culture Collection, Rockville, MD [8] National Collection Type Culture, London, England [9] Standard Methods for the Exminationof Water and Wastewater, Twentieth Edition American Public Health Association, 1015 Eithteenth Street NW, Washington, DC 20036 [10] APHA Intersociety/Agency Committee on Microbiological Methods for Foods, Compendium of Methods for Micorbiological Examination of Foods, 1976, pp.92-93 [11] American Society o Heating, Refrigerating, and air-conditioning Engineers, Inc., 1791 Tullie Circle, N.E., Atlanta, GA 30329. [12] First, M.W., Stuart, D., Webb, T., Report of NSF Standard Number 49 Ad Hoc Task Group to Recommend Revision to Appendis C, November 5, 1986