1

2

(

100

1,000 – 10,000

10,000 – 100,000

RI

3

(

A 100 100

B 10,000 100

C 100,000 10,000

D 100,000

16

4

ISO14644-1 1999(JIS B9920-2002)

5

CFU/ CFU/ H

A 100

B 10000 10 5

C 100000 100 50

D 200 100

16

6

•

?

7

Staphylococcus epidermidis

Staphylococcus aureus

Micrococcus sp.

Bacillus subtilis

Corynebacterium sp.

Acinetobacter baumannii

Burkholderia cepacia

Cryseobacterium meningosepticum

Cryseobacterium indologenes

Pseudomonas aeruginosa

Sphingomonas paucimobillis

Serratia marcescens

Stenotrophomonas maltophilia

Aspergillus niger

Rhodotorula sp.

Cladosporium sp.

Mucor sp.

Penicillium sp. 8

51151

9

HBV

10

••

• Clostridium difficile ( )• Clostridium botulinum ( )• Clostridium tetani ( )• Clostridium perfringens ( )• Bacillus cereus ( )• Bacillus subtilis ( )• Geobacillus stearothermophilus ( )

••

11

12

13

•

•

1

11 3

114

15

100,000 -

500,000 -

1,000,000 -

5,000,000 100,000

7,500,000 1,000,000

10,000,00016

17

18

•••••

19

ULPA

20

21

22

23

24

100 BEMCOT

25

100

26

27

28

29

30

31

32

33

34

35

36

37

38

Operating Qualification

39

•JIS Z8122 2000 4114

99.97

•JIS B9922 2001

•JIS K3800 2009

40

HEPAHEPA

41

•

•

•

42

43

• JIS B9920:2002• JIS B9917-3:2009• JIS B9917-3:2009• JIS B9917-3:2009 • JIS B9918-1:2008• JIS B9918-1:2008

44

1 3

(at-rest 45

10646

47

48

49

25c

50

51

52

53