AMERICAN
SOCIETY FOR TESTING AND MATERIALS (ASTM)
Standard specifications for Reagent
Water
|
ASTM
Type |
I |
II |
III |
IV |
|
Conductivity
@25oC
Microsiemens.cm |
0.056 |
1.0 |
0.25 |
5.0 |
|
Resistivity @25oC
Megohms.cm |
18 |
1.0 |
4.0 |
0.2 |
|
Total Silica
(µg/L) |
3 |
3 |
500 |
- |
|
Total Organic Carbon
(µg/L) |
100 |
50 |
200 |
- |
|
Chlorides
(µg/L) |
1 |
5 |
10 |
50 |
|
Sodium
(µg/L) |
1 |
5 |
10 |
50 |
|
pH * |
- |
- |
- |
5.0-8.0 |
|
|
Type A |
Type B |
Type C |
|
|
Max
Heterotrophic Bacteria Count |
10/1000
ml |
10/100
ml |
100/10
ml |
|
|
Endotoxin
(EU/ml) |
<0.03 |
0.25 |
N/A |
|
* The
measurement of pH in Type 1, II & III reagent water has been eliminated
because these grades
of
water do not contain constituents in sufficient quantity to alter pH.
COLLEGE OF
AMERICAN
PATHOLOGISTS
NATIONAL
COMMITTEE FOR CLINICAL LABORATORY STANDARDS
|
CAP/NCCLS
Type |
I |
II |
III |
|
|
Conductivity @25oC Microsiemens.cm |
0.1 |
1.0 |
10 |
|
|
Resistivity @25oC
Megohms.cm |
10 |
1.0 |
0.1 |
|
|
Silicate
(mg/L SiO2) |
0.05 |
0.1 |
1.0 |
|
|
pH |
- |
- |
5.0-8.0 |
|
|
|
Type A |
Type B |
Type C |
|
|
Bacteria
Growth (cfu/ml) |
10 a |
1000 |
- |
|
|
Particulate Matter |
0.2 µm
filter b |
N/A |
N/A |
|
|
Organics |
Activated
b Carbon |
N/A |
N/A |
|
a.
Preferably Type 1 should be bacteria free
b.
These are process specifications not measured by user
UNITED STATES
PHARMACOPEIA 29 STANDARDS
|
USP 29
Grade |
Purified |
WFI |
|
|
|
|
|
|
|
|
|
Organics |
|
|
|
|
|
Conductivity @25oC |
< 1.3
µS/cm |
< 1.3
µS/cm |
|
|
|
Endotoxin
by LAL test |
No
specification |
<0.25(EU/ml) |
|
|
|
Bacteria
(cfu/ml) |
<100 |
<10 |
|
|
ASSOCIATION FOR
THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)
Haemodialysis
Water Quality
ANSI/AAMI
RD62:2001
Maximum
allowable chemical contamination levels in water used to prepare dialysate and
concentrates
from powder at
a dialysis facility and to reprocess dialysers for multiple use a.
|
Contaminant |
Max Concentration (mg/L)
b |
|
Aluminium |
0.01 |
|
Antimony |
0.006 |
|
Arsenic |
0.005 |
|
Barium |
0.10 |
|
Beryllium |
0.0004 |
|
Cadmium |
0.001 |
|
Calcium |
2 (0.1 mEq/L) |
|
Chloramines |
0.10 |
|
Chromium |
0.014 |
|
Copper |
0.10 |
|
Floride |
0.20 |
|
Free Chlorine |
0.50 |
|
Lead |
0.005 |
|
Magnesium |
4 (0.3 mEq/L) |
|
Mercury |
0.0002 |
|
Nitrate (as N) |
2.00 |
|
Potassium |
8 (0.2 mEq/L) |
|
Selenium |
0.09 |
|
Silver |
0.005 |
|
Sodium |
80 (3.0 mEq/L) |
|
Sulfate |
100 |
|
Thallium |
0.002 |
|
Zinc |
0.10 |
|
|
|
|
Microbiological |
< 200 cfu/ml |
|
Endotoxin |
< 2 EU/ml |
a.
The physician has the ultimate responsibility for ensuring
the quality of water used for dialysis.
b.
Unless otherwise noted
