Ver. 2.0

201 3 11

1

11 50

22

AB

HDF/HF

HDF/HF

HDF/HF

5121

MF

512

51

AB

HDF/HF

2

Reverse Osmosis : RO

5352 TOC

RO

UF

RO

BA

BB

B

A

A

ET Retentive filter(ETRF)

HDF/HF

Annex

3

2004 ISO/AAMI

2009ISO 116635

139586)1395972672282011ISO 235009

20101HDF/HF

4

2012403051

HDF2

HDF/HF

ISO

32

17710

4

http://www.mhlw.go.jp/topics/bukyoku/kenkou/suido/kijun/kijunc

hi.html

11 50H23.4.1

1 100/mL

2

0.003mg/L

0.0005mg/L

5 0.01mg/L

6 0.01mg/L

7 0.01mg/L

0.05mg/L

9 0.01mg/L

10 10mg/L

11 0.8mg/L

12 1.0mg/L

13 0.002mg/L

14 1,4- 0.05mg/L

15 -1,2--1,2-

214 0.04mg/L

16 0.02mg/L

17 0.01mg/L

18 0.01mg/L

19 0.01mg/L

20 0.6 mg/L

21 0.02mg/L

22 0.06mg/L

http://www.mhlw.go.jp/topics/bukyoku/kenkou/suido/kijun/kijunchi.htmlhttp://www.mhlw.go.jp/topics/bukyoku/kenkou/suido/kijun/kijunchi.html

5

23 0.04mg/L

2 0.1mg/L

25 0.01mg/L

26 0.1mg/L

27 0.2mg/L

28 0.03mg/L

29 0.09mg/L

30 0.08mg/L

31 1.0mg/L

32 0.2mg/L

33 0.3mg/L

34 1.0mg/L

35 200mg/L

36 0.05mg/L

37 200mg/L

38 () 300mg/L

39 500mg/L

40 0.2mg/L

41 0.00001mg/L

42 2- 0.00001mg/L

43 0.02mg/L

44 0.005mg/L

45 (TOC) mg/L

46 pH 5.88.6

47

48

49 5

50 2

ISO

139597)ISO 235009)1

6

22

No mg/L

1 2 (0.1mEq/L)

2 (0.3mEq/L)

3 8 (0.2mEq/L)

70 (3.0mEq/L)

5 0.006

6 0.005

7 0.10

8 0.000

9 0.001

10 0.01

11 0.005

12 0.0002

13 0.09

1 0.005

15 0.01

16 0.10

1 0.10

1 0.20

2.0

100

0.002

0.10

Annex

7

0.0EU/mL 0.001 EU/mL

1 CFU/mL 0.CFU/mL

L100mL

AB

0.00EU/mL

1 CFU/mL 0.CFU/mL

L100mL

2 HDF/HF

0.001EU/mL

1 CFU/mL

L100mL

0.00EU/mL

1 CFU/mL 0.CFU/mL

L100mL

0.001EU/mL

0.1 CFU/L

0L100mL

0.001EU/mL

0.1 CFU/L 1 CFU/L

0L100mL

8

HDF/HF

0.001EU/mL

1 CFU/mL

L100mL

HDF/HF

0.001EU/mL

1 CFU/mLnot detected

0L100mL

RO

AB

A 40 B 20

MF

Reasoners Agar No2

20

RA

0.05100L

9

5121

512 MF

MF m

11

512

HDF/HF

12)13)

1

RO

RORO

500mL/min

10

AB

Annex

500mL/min

500mL/min

2ETRF

HDF/HF

500mL/min

22ETRF

11

1

RO

25 m

P

RO)

12

CaMgAl Na

Na

NaNa

NaCl

Na

0.1mg/L

FRP

13

DPDP

Reverse Osmosis : RO

RO RO

RO

RO

5351

RO 5075

/100

5075

14

5352 Total Organic CarbonTOC

RO

TOC

0.5mg/L500ppb

TOC

535

RO

25

535 RO

RO

RO

RO RO

3 RO

RO 56

RO

DNA 260nm

253.7nm

15

7,0008,000

RO

A

UF

ROET100ROUF

RO

UF

UF

UF

UFET

ROET

UF

ROUF

3 RO

ROICU

16

1/1/

RO

RO

BBA

A

BA

B

AA

B

B

BB

B

ETB

100ppm

B

17

B

B

BA

B

A

A

A

ET

A

A

pH

5

18

ET Retentive filterETRF

ETETRF

ETRF

ETRF

ETRF

ET

ET

19

0.020.1

Na 30 RO

HDF/HF

HDF JIS T

3250 4.5.2 HDF

20

1) .

.2004.126-132

2) Clinical Engineering 6

2005 Vol No.5.548-556

1) Henderson LW,Koch KM,Dinarello CA,et all Hemodialysis

hypotensionThe interleukin hypothesis,Blood purification 1: 3-8,

1983

2) VOL.30.NO,1

13-20, 2002

3) VOL.30.NO,7

427-429, 2002

4) Schindler R,Beck W,Deppisch R,et al:Short bacterial DNA

fragments:detection in dialysate and induction of cytokinesJ Am Soc

Nephrol 15(12):3207-3214,2004

5) ISO 11663Quality of dialysis fluid for haemodialysis and related

therapies.

First edition 2009-04-15

6) ISO 13958Concentrates for haemodialysis and related

therapies .Second edition 2009-04-15

7) ISO 13959Water for haemodialysis and related therapies. Second

edition 2009-04-15

8) ISO 26722Water treatment equipment for haemodialysis

applications and related therapies. First edition 2009-04-15

9) ISO 23500Guidance for the preparation and quality management

of fluids for haemodialysis and related therapies. First edition

2011-05-15

10) 101 2005

11)

42(1):85-90,2009

12) 33:

, 2009

13) RO

40(12):1051-1056,2007

21

14) 2011 (ETRF)

44(9):977~990,2011

Annex

ISO

1) http://www.iso.org/iso/store.htm

2) http://www.webstore.jsa.or.jp/webstore/ISO/html/jp/menu.htm?lang=jp

3 RO

RO

RO 510

100

4RO

ET

RO 100

0.15ET

O

1 EU ET

ET

5

ET

6

137 134 131

22

90%

7

512 MF

L

MF