
ii
The
P2131
Automated
Field
Steam
Sterilizer
complies
with
the
applicable
requirements
of
the
following
standards:
ANSI/AAMI
ST8:2013,
Hospital
Steam
Sterilizers
UL
61010
‐
1
2nd
Edition,
Safety
Requirements
for
Electrical
Equipment
for
Measurement,
Control
and
Laboratory
Use
–
Part
1
General
Requirements
IEC
61010
‐
2
‐
040
1st
Edition,
Safety
requirements
for
electrical
equipment
for
measurement,
control
and
laboratory
use
‐
Part
2
‐
040:
Particular
requirements
for
sterilizers
and
washer
‐
disinfectors
used
to
treat
medical
materials
ASME
Boiler
and
Pressure
Vessel
Code,
Section
VIII,
Division
I,
Current
Edition,
Rules
for
Construction
of
Pressure
Vessels
U
Fort
Defiance
Industries
(FDI)
is
ISO
13485:2016
certified
and
FDA
compliant
for
the
design
and
manufacture
of
medical
devices
and
supportive
accessories
for
the
medical
device
industry.
Fort
Defiance
Industries
LLC
Certified
to
ISO
13485:2016
MDSAP:
United
States,
Canada
Certificate
#:
US19/81841407
Содержание P2131
Страница 121: ... THIS PAGE INTENTIONALLY LEFT BLANK 115 ...
Страница 130: ...SECTION A APPENDIX 124 ...
Страница 131: ...A 1 Swagelok Fitting Installation Instructions 125 ...
Страница 135: ...A 2 PLC Data Sheet 129 ...
Страница 141: ...A 3 VERIFY Product Information 135 ...
Страница 147: ...A 4 WRS Pump Information 141 ...
Страница 158: ...A 5 Vacuum Leak Test Troubleshooting Guide 152 ...