Medical Sterilization Methods - Lemo
Medical Sterilization Methods - Lemo
UMDNS information
This Product Comparison covers the following de-
vice term and product code as listed in ECRI’s
Universal Medical Device Nomenclature System™
(UMDNS™):
• Sterilizing Units, Steam, Bulk [16-141]
Purpose
Steam sterilizers use pressurized steam to generate
moist heat to eliminate viable microbes from non-heat-
sensitive medical devices, including heat-tolerant
products used for surgical and general patient care.
Principles of operation
Items to be sterilized are cleaned to remove contami-
nants, such as feces, dried blood, and sputum, and
rinsed with distilled or demineralized water to remove
any detergent or tap-water residues. They are put into
packs and loaded into baskets or carts that are placed
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Sterilizing Units, Steam, Bulk
fluids in reusable glass bottles with covers that allow indicators. Biological indicators are heat-resistant bac-
the passage of air; at prevacuum sterilizing tempera- terial spores that respond to sterilization much like the
tures, the liquid can boil away, and rapid exhausting actual microorganisms that may be present in a load.
can pop the covers off the bottles. Most prevacuum Chemical indicators determine whether a pack or con-
sterilizers, therefore, can also use gravity to remove air tainer was processed properly and can help detect
when processing sterile fluids. sterilization failures resulting from improper packag-
ing or loading or inaccurate steam temperatures.
In the steam flush-pressure pulse method, the
chamber is kept above atmospheric pressure, and air
is removed by a sequence of steam flushes and pressure Reported problems
pulses. Steam flush-pressure pulse units perform at
The steam sterilizer is an integral component in a
least as rapidly as vacuum sterilizers and at tempera-
complex system used to provide sterile products for
tures of 132° to 135°C (270° to 275°F). Because of the
patient care. This system includes collecting, clean-
above-atmospheric pressure, leaks cannot interfere
ing, and laundering used instruments and linen; wrap-
with the sterilization process, and Bowie-Dick moni-
ping packs; loading the sterilizer; using biological and
toring may not be needed. Sterilizers can be reconfig-
chemical indicators; monitoring steam pressure and
ured to perform this process if they are not equipped
quality; and storing the sterilized items. Therefore, it
to do so already.
is often difficult to determine the cause of problems
Flash sterilization is used to quickly sterilize instru- associated with steam sterilization processing.
ments that have become contaminated during surgery
and need to be reused. This rapid sterilization process The most notable problem is occasional false-positive
does not use full cycles of exposure and drying times. biological indicators, which can occur even though the
Exposure cycles are shortened by eliminating wrap- steam sterilizer is functioning properly. The biological
ping material or using sterilization containers that indicators, or the way in which they are handled or
ensure that all instruments are fully exposed to the incubated, may be at fault. Variabilities among biologi-
steam. Recent criticism of the sterilizing efficacy of this cal indicators can also cause false-positive results.
method has caused the Association for the Advance-
A common problem with vacuum steam sterilizers
ment of Medical Instrumentation to issue the following
is inadequate air removal from the sterilization cham-
recommendations for using flash sterilization:
ber, which can usually be traced to a worn door gasket
• Use only when the sterilized items are urgently or to problems with the vacuum system. This is tested
needed. using a prevacuum test pack (commonly known as a
Bowie Dick indicator). This problem does not affect
• Follow proper procedures before sterilization, such
steam flush-pressure pulse sterilizers because they
as cleaning, decontaminating, and inspecting in-
operate above atmospheric pressure.
struments and properly arranging items in the con-
tainer or tray. The mechanical safety of steam sterilizers is a con-
• Position the sterilizer close to the point of instru- cern because the sterilization chamber is under signifi-
ment use. cant positive or negative pressure at different times
during the cycle. All bulk steam sterilizer chambers
• Develop procedures to ensure proper aseptic instru- manufactured in the United States must conform to
ment handling and safety during the transfer of the applicable requirements of the American Society
sterilized items. of Mechanical Engineers Code for Boiler and Pressure
Sterilization cycles and variables can be displayed Vessels (see Standards and Guidelines below). One
graphically by a circle-chart recorder or alphanumeri- sterilizer explosion resulted from improper mainte-
cally by a microprocessor-controlled data reporter. nance of the electric steam generator beneath the
Both provide the date and time and indicate if any sterilizer (a pressure-relief valve was erroneously re-
problems have occurred that might adversely affect the placed with a plug). Other reported problems involve
sterilization cycle. The information can also be digi- worn parts affecting the mechanical integrity of the
tally displayed on the control panel. Many autoclaves chamber door and defective circuit boards causing
have audible and/or visible alarms to indicate interfer- smoke and fires within affected units. It is important
ence with the sterilization cycle; some have indicators that hospitals have regular preventive maintenance
that signal cycle completion. and inspection of their steam sterilizers.
The performance and effectiveness of a steam steril- Wet steam can cause sterilization problems, including
izer should be tested using both biological and chemical wet or damp packs, standing water on packs, stained
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Healthcare Product Comparison System
wrapper materials and pack contents, and deterio- specifications have been categorized into one group
rated pack wrappers. Wet steam is commonly defined including all sterilizers with chamber sizes 2 m3.
as steam with a water-vapor content ≥3% (i.e., a% dry
Temperature ranges for steam sterilization should
steam) and is primarily caused by condensation in steam
be at least 121°C (250°F), which is the lowest com-
lines; other sources of wet steam include improper opera-
monly accepted temperature. Steam sterilizers should
tion of steam traps or the hospital’s boiler. As steam
have microprocessor controllers because they allow for
travels from the boiler to the sterilizers, condensation
more precise control and monitoring of sterilization
forms, causing an increase in the water-vapor content.
cycles. Also, to ensure that sterility is achieved, steril-
Sterilizers supplied with their own electric steam gener-
izers should record time and temperature. All cham-
ator usually have fewer wet-steam problems.
bers must conform with the ASME (American Society
Marginal steam quality may not be discovered unless of Mechanical Engineers) pressure vessel codes to en-
the hospital switches to barrier-type linens and pack sure safety (see Standards and Guidelines).
wrappers, which are less penetrable by steam and water
vapor. Muslin wrappers and linens are more penetrable Other considerations
during the sterilization and drying cycles and therefore The initial cost of a bulk steam sterilizer can vary
are less affected by marginal steam quality. from approximately $20,000 for an 18 ft3 (0.5 m3)
The type of wrapper material, pack density, and transfer-cart-loading vacuum sterilizer to about
chamber-loading technique can contribute to pack $600,000 for a large floor-loading vacuum unit that can
damage. Staining can result from rust contamination accommodate two carts. Features that significantly
of the steam supply lines, chemicals used to treat the contribute to price include the following:
boiler feed water carrying over into the steam, and • Method of air removal (i.e., gravity units typically
interaction of minerals and chemicals in the hospital’s cost less than other units)
main water supply with boiler-treatment chemicals. • Chamber size
Much of the criticism of flash sterilization focuses • Manual or power doors
on the short time the instrument load is exposed to the
• Controller options
steam. However, contamination of treated instru-
ments may actually result from presterilization and • Auxiliary loading equipment
poststerilization handling and not by an ineffective • Service contracts
rapid sterilization method — for instance, users might
inadequately clean and decontaminate items before • Trade-in equipment
sterilizing them, or unwrapped items might be con- • Delivery area
taminated as they are being carried to the sterile field. • Freight charges
Although this belief is gaining widespread acceptance
among infection control experts, at least one state has Several of these features also affect the cost of auto-
passed laws limiting the use of flash sterilization to claves, including method of air removal, controller
instances when there is an immediate need for steril- options, and service contracts.
ized items and no readily available alternative.
Cost containment
Manufacturers typically provide technical bulletins
Because bulk steam sterilizers entail ongoing main-
for each available size or model of sterilizer. These
tenance and operational costs, the initial acquisition
bulletins include detailed information on design and
cost does not accurately reflect the total cost of owner-
operating features, options, utilities requirements,
ship. Therefore, a purchase decision should be based
and installation considerations. Potential buyers
on issues such as life-cycle cost (LCC), local service
should obtain specific bulletins once they have defined
support, discount rates and non-price-related benefits
their needs regarding sterilizer type (gravity, vacuum,
offered by the supplier, and standardization with ex-
or steam flush-pressure pulse), loading (transfer cart
isting equipment in the department or hospital (i.e.,
or wheeled floor cart), and chamber size.
purchasing all sterilizers from one supplier).
Purchase considerations An LCC analysis can be used to compare high-cost
alternatives and/or to determine the positive or nega-
ECRI recommendations
tive economic value of a single alternative. For exam-
Included in the accompanying comparison chart are ple, hospitals can use LCC analysis techniques to
ECRI’s recommendations for minimum performance examine the cost-effectiveness of leasing or renting
requirements for bulk steam sterilizers; recommended equipment versus purchasing the equipment outright.
4 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
Because it examines the cash-flow impact of initial • Costs associated with replacement trays, carts,
acquisition costs and operating costs over a period of shelves, etc.
time, LCC analysis is most useful for comparing
• Installation costs, which may include removing
alternatives with different cash flows and for reveal-
units that are being replaced and/or fitting a dedi-
ing the total costs of equipment ownership. One LCC
cated steam pipe from the physical plant, as well as
technique — present value (PV) analysis — is espe-
either connecting the sterilizer to the exhaust line
cially useful because it accounts for inflation and for
of the hospital heating, ventilating, and air-condi-
the time value of money (i.e., money received today is
tioning system or installing a dedicated exhaust
worth more than money received at a later date).
duct to the outside of the building.
Conducting a PV/LCC analysis often demonstrates
that the cost of ownership includes more than just the As illustrated by the above sample PV/LCC analysis,
initial acquisition cost and that a small increase in the initial acquisition cost is only a fraction of the total
initial acquisition cost may produce significant savings cost of operation over 10 years. Therefore, rather than
in long-term operating costs. The PV is calculated making a purchase decision based solely on the acquisi-
using the annual cash outflow, the dollar discount tion cost of a sterilizing unit, buyers should consider
factor (the cost of capital), and the lifetime of the operating costs over the lifetime of the equipment.
equipment (in years) in a mathematical equation.
For further information on PV/LCC analysis, cus-
The following represents a sample 10-year PV/LCC tomized analyses, and purchase decision support,
analysis for a medium-sized (0.85 m3) bulk sterilizer. readers should contact ECRI’s SELECT™ Group.
Present Value/Life-Cycle Cost Analysis Energy consumption is the main factor contributing
to a bulk sterilizer’s long-term operating costs. Elec-
Assumptions tricity costs can vary greatly depending on the unit’s
size, method of air removal (i.e., gravity units are less
• Operating costs are considered for years 1 through 10
expensive to run than other sterilizers), and the con-
• Dollar discount factor is 6% troller electronics system.
• Inflation rate is 6% for operating costs Hospitals can purchase service contracts or service
on a time-and-materials basis from the supplier. Serv-
• Average of 8 loads/day for 1 sterilizer
ice may also be available from a third-party organiza-
• Cost per load includes labor, maintenance/service tion. The decision to purchase a service contract should
contracts, supplies (e.g., biological monitors, record- be carefully considered; it can be justified for several
ing paper), steam, electricity, and water (O’Shaugh- reasons. Purchasing a service contract ensures that
nessy 1993) preventive maintenance will be performed at regular
intervals, thereby eliminating the possibility of unex-
• Costs of maintenance/service contracts in first year
pected maintenance costs. Also, many suppliers do not
of operation is included in warranty
extend sterilizer performance guarantees beyond the
Capital Costs length of the warranty unless the system is covered by
• Sterilizer = $80,000 a service contract.
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 5
Healthcare Product Comparison System
little in that time. Microprocessor controls have been Good hospital practice: steam sterilization and ste-
incorporated to increase the sterilizer’s reliability and rility assurance [recommended practice]. 3rd ed.
ease of use. Newer models offer such features as built- ANSI/AAMI ST46-1993. 1994.
in safety devices, the ability to be modified with addi- Guidelines for the selection and use of reusable rigid
tional safety components (e.g., door-interlock systems, sterilization container systems for ethylene oxide
audible alarms), and preprogrammed sterilization cy- sterilization and steam sterilization in health care
cles. Future enhancements may include the use of facilities [standard]. 2nd ed. ANSI/AAMI ST33-
microwave or ultraviolet radiation to sterilize heat- 1996. 1990 (revised 1996).
and steam-sensitive devices.
Hospital steam sterilizers [standard]. ANSI/AAMI
ST8-1994. 2002.
Bibliography
American Society for Healthcare Central Service Profes-
Caporino PP. How effective are chemical and biological sionals. Recommended practice for central service sec-
sterilization indicators? J Healthc Mater Manage tion six: sterilization. Committee for Recommended
1991 Jan-Feb;9(1):32-44. Practices. C-013833. 1989 (revised 2001).
Crow S. Steam sterilizers: an evolution in design. American Society of Mechanical Engineers. Pressure
Infect Control Hosp Epidemiol 1993 Aug;14(8):488- relief devices [standard]. ASME PTC-25-1994. 1994.
90. British Standards Institution. Sterilizing and disin-
fecting equipment for medical products. Specifica-
Favero MS. Sterilization and infection prevention: tion for general requirements. [standard]. BS
what you need to know. Asepsis 1994 4th Quarter; 3970.1990.
16(4):16-9.
Sterilizing and disinfecting equipment for medical
Harris MH. Flash sterilization: is it safe for routine products. Specification for steam sterilizers for
use? AORN J 1992 Jun;55(6):1547-51. aqueous fluids in sealed rigid containers [standard].
BS 3970:part 2. 1991.
Lind N. Steam sterilization. J Healthc Mater Manage
Sterilizing and disinfecting equipment for medical
1994 Nov;12(11):56-8.
products. Specification for transportable steam ster-
O’Shaughnessy KL. Steam sterilization costs: a guide ilizers for unwrapped instruments and utensils
for the central service manager. J Healthc Mater [standard]. BS 3970:part 4. 1990.
Manage 1993 Jul;11(6):40-5. Canadian Standards Association. Effective steriliza-
tion in health care facilities by the steam process
Smith RF. Sterile? The ten parameters of steam ster-
[standard]. CAN/CSA-Z314.3-M01. 1991 (revised
ilization. J Healthc Mater Manage 1986 Jul-Aug;
2001).
4(4):34-9.
Steam sterilizers for hospitals [standard].
Young JH. Comparison of in-hospital and industrial CAN/CSA-Z314.7-M91.1991 (reaffirmed 2000).
sterilization of medical devices. J Healthc Mater
European Committee for Standardization. Biological
Manage 1986 Mar-Apr;4(2):30-4.
systems for testing sterilizers and sterilization proc-
esses — part 3: particular systems for use in moist
Standards and guidelines heat sterilizers [standard]. EN 866-3:1993. 1997.
Note: Although every effort is made to ensure that the Sterilization — steam sterilizers — large sterilizers
following list is comprehensive, please note that other [standard]. EN 285:1996. 1996.
applicable standards may exist. International Electrotechnical Commission. Medical
American National Standards Institute/Association electrical equipment — part 1: general require-
for the Advancement of Medical Instrumentation. ments for safety [standard]. IEC 60601-1-1 (1988-
Sterilization of health care products. Biological in- 12). 1988 (revised 2000).
dicators: Part 3: Biological indicators for moist heat Medical electrical equipment — part 1: general re-
sterilization [standard]. 2nd ed. ANSI/AAMI ST19- quirements for safety. Amendment 1 [standard].
1986. 1986 (revised 1999). IEC 60601-1-am1 (1991-11). 1991.
Flash-sterilization: steam sterilization of patient Medical electrical equipment — part 1: general re-
care items for immediate use [standard]. 3rd ed. quirements for safety. Amendment 2 [standard].
ST37-006-MM. 1996. IEC 60601-1-am2 (1995-03). 1995.
6 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
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Healthcare Product Comparison System
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Sterilizing Units, Steam, Bulk
MMM PriorClave
MMM Muenchener Medizin Mechanik GmbH PriorClave Ltd [192831]
[160098] 129-131 Nathan Way
Semmelweisstrasse 6 Thamesmead
D-82152 Planegg/Muenchen London SE28 0AB
Germany England
Phone: 49 (89) 899180 Phone: 44 (20) 83166620
Fax: 49 (89) 89918118 Fax: 44 (20) 88550616
E-mail: info@mmmgroup.com E-mail: sales@priorclave.co.uk
Internet: http://www.mmmgroup.com Internet: http://www.priorclave.co.uk
Nuve Rautoclave
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Healthcare Product Comparison System
Sauter
Sauter AG [186709] TECNO-GAZ
Alviereg 17
CH-9490 Vaduz
Switzerland TECNO-GAZ SpA [152517]
Phone: 41 (42) 32375730 strada Cavalli 4
Fax: 41 (42) 32320336 I-43038 Sala Baganza PR
Italy
Phone: 39 (0521) 833926
Sterilizing Systems
Fax: 39 (0521) 833391
Sterilizing Systems [146777] E-mail: info@tecnogaz.com
PO Box 1388 Internet: http://www.tecnogaz.com
Alpharetta GA 30009
Phone: (770) 475-1099
Fax: (770) 751-1256
E-mail: sterilizingsys@mindspring.com Tomy Tech
STERIS
Tomy Tech USA Inc [161286]
STERIS Corp [107114] 40479 Encyclopedia Circle
5960 Heisley Rd Fremont CA 94538
Mentor OH 44060-1834 Phone: (510) 440-1976, (800) 545-8669
Phone: (440) 354-2600, (800) 548-4873 Fax: (510) 440-1975
Fax: (440) 354-2321 E-mail: info@tomytech.com
Internet: http://www.steris.com Internet: http://www.tomytech.com
10 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
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Healthcare Product Comparison System
CGMP — Current Good Manufacturing Practices Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
CIF — Common Intermediate Format independent testing by ECRI or any other agency.
Because test methods vary, different products’ specifi-
CLA — City of Los Angeles
cations are not always comparable. Moreover, products
CRN — Canadian Registration Number and specifications are subject to frequent changes.
ECRI is not responsible for the quality or validity of
CRT — Cathode ray tube the information presented or for any adverse conse-
CSA — Canadian Standards Association quences of acting on such information.
DIN — Deutsches Institut fuer Normung When reading the charts, keep in mind that, unless
otherwise noted, the list price does not reflect supplier
EC — European Community discounts. And although we try to indicate which
features and characteristics are standard and which
EEC — European Economic Community
are not, some may be optional, at additional cost.
EMC — Electromagnetic compatibility
For those models whose prices were supplied to us
EN — European Norm in currencies other than U.S. dollars, we have also
listed the conversion to U.S. dollars to facilitate com-
ETL — ETL Testing Laboratories parison among models. However, keep in mind that
FDA — U.S. Food and Drug Administration exchange rates change often.
12 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 61 x 91.4 x 91.4 66 x 157.5 x 106.7 40 x 40 x 60 (15.7 x
(24 x 36 x 36), (26 x 62 x 42), 15.7 x 23.6),
61 x 91.4 x 121.9 66 x 157.5 x 193 60 x 60 x 80 (23.6 x
(24 x 36 x 48), (26 x 62 x 76), 23.6 x 31.5),
61 x 91.4 x 152.4 custom to order 60 x 60 x 120
(24 x 36 x 60), (23.6 x 23.6 x 47.2)
custom to order
VOLUME,
m3 (ft3) >2 (71) 0.51 (18), 1.1 (39), 0.096 (3.39),
0.68 (24), 2 (71) 0.288 (10.17),
0.85 (30) 0.432 (15.25)
Steam flush-
pressure pulse ≥121 (250) NA NA NA
CONTROLLER Microprocessor Automatic Automatic Automatic
controller
RECORDER Time, temperature Circle chart or Circle chart or NA : Optional
printer printer printer
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 13
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 120, controls ** 120, controls ** NA
Steam flush-
pressure pulse,
VAC NA NA NA
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Sterilizing Units, Steam, Bulk
FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Not specified Not specified Not specified Not specified
AIR REMOVAL Gravity Vacuum Vacuum Gravity
CHAMBER SIZES
W x H x D, cm (in) 40 x 40 x 60 40 x 46 x 60 (15.7 x 46 x 46 x 60 (18.1 x 40 (dia) x 60
(15.7 x 15.7 x 23.6) 18.1 x 24), 46 x 46 18.1 x 24), 46 x 46 (15.7 x 23.6),
x 120 (18.1 x 18.1 x x 120 (18.1 x 18.1 x 40 x 40 x 60
47.2), 46 x 66 x 120 47.2), 46 x 66 x 120 (15.7 x 15.7 x
(18.1 x 26 x 47.2), (18.1 x 26 x 47.2), 23.6), 40 x 40 x 120
66 x 66 x 160 (26 x 66 x 66 x 160 (26 x (15.7 x 15.7 x 47.2)
26 x 63), 66 x 66 26 x 63), 66 x 66
x 200 (26 x 26 x x 200 (26 x 26 x
78.7) 78.7)
VOLUME,
m3 (ft3) 0.096 (3.39) 0.14 (4.9), 0.25 0.14 (4.9), 0.25 0.096 (3.39), 0.19
(9), 0.36 (12.9), (9), 0.36 (12.9), (6.71)
0.52 (18.5), 0.69 0.52 (18.5), 0.69
(24.6), 0.87 (30.7) (24.6), 0.87 (30.7)
CHAMBER MATERIAL 316L stainless steel 316L stainless steel 316L stainless steel 316L stainless steel
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Automatic Automatic Automatic Automatic
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 15
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 220/380 NA NA 220/380
Steam flush-
pressure pulse,
VAC NA NA NA NA
Delivery time, ARO 4-8 weeks 4-8 weeks 4-8 weeks 4-8 weeks
Training Not specified Not specified Not specified Not specified
Fiscal year Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS None specified. None specified. None specified. None specified.
16 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 40 (dia) x 60 40 x 46 x 60 (15.7 x 66 x 123 x 104 66 x 108 x 104
(15.7 x 23.6), 18.1 x 23.6), 46 x (26 x 48.4 x 40.9), (26 x 42.5 x 40.9),
40 x 40 x 60 46 x 120 (18.1 x 66 x 123 x 140 66 x 108 x 140
(15.7 x 15.7 x 18.1 x 47.2), 46 x (26 x 48.4 x 55.1), (26 x 42.5 x 55.1),
23.6), 40 x 40 x 120 66 x 120 (18.1 x 26 66 x 123 x 170 66 x 108 x 170
(15.7 x 15.7 x 47.2) x 47.2), 66 x 66 x (26 x 48.4 x 66.9), (26 x 42.5 x 66.9),
160 (26 x 26 x 63), 66 x 123 x 200 66 x 108 x 200
66 x 66 x 200 (26 x (26 x 48.4 x 78.7) (26 x 42.5 x 78.7)
26 x 78.7)
VOLUME,
m3 (ft3) 0.096 (3.39), 0.19 0.14 (4.9), 0.25 0.84 (30), 0.74 (26),
(6.71) (9), 0.36 (12.9), 1.13 (40), 1 (35),
0.52 (18.5), 0.69 1.38 (48), 1.21 (42),
(24.6), 0.87 (30.7) 1.62 (57) 1.42 (50)
CHAMBER MATERIAL 316L stainless steel 316L stainless steel Stainless steel Stainless steel
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Automatic Automatic Microprocessor Microprocessor
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 17
Healthcare Product Comparison System
Vacuum models, VAC NA 220/380 208 VAC, 3-phase 208 VAC, 3-phase
Steam flush-
pressure pulse,
VAC NA NA NA NA
Warranty 1 year, parts; 1 year, parts; 1 year, parts and 1 year, parts and
5 years, chamber 5 years, chamber labor including PMs labor including PMs
vessel vessel
Delivery time, ARO 4-8 weeks 4-8 weeks 4-5 months 4-5 months
Training Not specified Not specified 1-2 days on-site, 1-2 days on-site
optional at factory optional at factory
Year first sold 1952 1952 2002 2002
Number installed
USA/worldwide Not specified Not specified Not specified Not specified
Fiscal year Not specified Not specified January to December January to December
OTHER SPECIFICATIONS None specified. None specified. Microprocessor Microprocessor
controls; non- controls; non-
proprietary proprietary
industrial industrial
components; all components; all
stainless components stainless components
for pure-steam for pure-steam
operation; water- operation; water-
saving option, <1 saving option, <1
gallon/cycle; gallon/cycle;
data-management data-management
capabilities. capabilities.
18 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 66 x 66 x 70 61 x 91.4 x 91.4 45 x 45 x [70, 100, 66 x 66 x [70, 100,
(26 x 26 x 27.6), (24 x 36 x 36) : 125] (17.7 x 17.7 x 125, 160, 190]
66 x 66 x 100 61 x 91.4 x 121.9 [27.6, 39.4, 49.2]) (26 x 26 x [27.6,
(26 x 26 x 39.4), (24 x 36 x 48) : 39.4, 49.2, 63,
66 x 66 x 130 61 x 91.4 x 152.4 74.8])
(26 x 26 x 51.2) (24 x 36 x 60)
VOLUME,
m3 (ft3) 0.30 (11), 0.42 (15) 0.14 (4.9) : 0.35 (12.4) :
0.44 (15), 0.20 (7.1) : 0.43 (15.2) :
0.57 (20) 0.25 (8.8) 0.59 (20.8) :
0.69 (24.4) :
0.82 (29)
CHAMBER MATERIAL Stainless steel Nickel-clad or AISI 316Ti AISI 316Ti
stainless steel
Steam flush-
pressure pulse Not specified Not specified Not specified Not specified
CONTROLLER Microprocessor Automatic Programmable logic Programmable logic
systems systems
RECORDER Printer and/or store Recorder/chamber Printer Printer
to remote computer
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 19
Healthcare Product Comparison System
Vacuum models, VAC 208 VAC, 3-phase As required 240-400, 24 kW 240/400, 31 kW/49 kW
Steam flush-
pressure pulse,
VAC NA Not specified Not specified Not specified
Fiscal year January to December October to September January to December January to December
OTHER SPECIFICATIONS Microprocessor All brass pipes. Optional supervision Optional supervision
controls; non- Meets requirements management system, management system,
proprietary of CSA and UL. sterilization sterilization
industrial management system. management system.
components; all Meets requirements Meets requirements
stainless components of CE 93/42, DIN, of CE 93/42, DIN,
for pure-steam EN, ISO, TUV. EN, ISO, TUV.
operation; water-
saving option, <1
gallon/cycle;
data-management
capabilities.
20 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 40.6 (dia) x 61 40.6 (dia) x 61 61 x 61 x 91.4 40.6 x 40.6 x 66
(16 x 24) : (16 x 24) : (24 x 24 x 36) : (16 x 16 x 26),
40.6 (dia) x 91.4 50.8 (dia) x 91.4 61 x 61 x 121.9 50.8 x 50.8 x 96.5
(16 x 36) : (20 x 36) (24 x 24 x 48) : (20 x 20 x 38)
50.8 (dia) x 91.4 61 x 91.4 x 91.4
(20 x 36) : (24 x 36 x 36) :
50.8 (dia) x 121.9 61 x 91.4 x 121.9
(20 x 48) : (24 x 36 x 48) :
61 (dia) x 90.4 61 x 91.4 x 152.4
(24 x 35.6) (24 x 36 x 60)
VOLUME,
m3 (ft3) 0.08 (2.8) : 0.08 (2.8) : 0.35 (12) : 0.12 (3.9),
0.13 (4.2) : 0.19 (6.3) 0.47 (16) : 0.26 (8.7)
0.19 (6.3) : 0.52 (18) :
0.26 (8.7) : 0.70 (24) :
0.27 (8.9) 0.87 (30)
CHAMBER MATERIAL Stainless steel Stainless steel Nickel-clad steel Nickel-clad steel
(optional Monel) (optional Monel) (optional stainless (optional stainless
steel) steel)
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Manual (optional Manual (optional Manual (optional Manual (optional
automatic) automatic) automatic) automatic)
RECORDER Strip or circle Strip or circle Strip or circle Strip or circle
chart (controller chart (controller chart (controller chart (controller
dependent) dependent) dependent) dependent)
DOORS Single or double Single or double Single or double Single or double
Operation Manual Manual Manual Manual
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 21
Healthcare Product Comparison System
Steam flush-
pressure pulse,
VAC NA NA NA NA
Warranty 1 year, parts and 1 year, parts and 1 year, parts and 1 year, parts and
labor labor labor; 15 years, labor; 15 years,
nickel-clad steel nickel-clad steel
chambers chambers
Delivery time, ARO 90-120 days 90-120 days 90-120 days 90-120 days
Training Maintenance/opera- Maintenance/opera- Maintenance/opera- Maintenance/opera-
ting manual, on-site ting manual, on-site ting manual, on-site ting manual, on-site
Year first sold 1948 1948 1948 1948
Number installed
USA/worldwide ~7,500 world- ~7,500 world- ~7,500 world- ~7,500 world-
wide wide wide wide
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Double-wall stain- Single-wall stain- Solid-state digital Solid-state digital
less steel chamber; less steel chamber; automatic controls automatic controls
solid-state digital solid-state digital or microprocessor or microprocessor
automatic controls automatic controls controls with CRT controls with CRT
or microprocessor or microprocessor display; display;
controls with CRT controls with CRT available with available with
display; strip- or display; strip- or strip- or circle- strip- or circle-
circle-chart circle-chart chart recorder; chart recorder;
recorder; cycle recorder; cycle cycle lockout cycle lockout
lockout; automatic lockout; automatic against unauthorized against unauthorized
utility shutdown utility shutdown use; automatic use; automatic
available; available; utility shutdown utility shutdown
most units can be most units can be available; most available; most
fitted with an fitted with an units can be fitted units can be fitted
integral electri- integral electri- with an integral with an integral
cally heated steam cally heated steam electrically heated electrically heated
generator; all generator; all steam generator; all steam generator; all
orders custom made. orders custom made. orders custom made. orders custom made.
Meets requirements Meets requirements Meets requirements Meets requirements
of ASME and CSA. of ASME and CSA. of ASME and CSA. of ASME and CSA.
22 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 66 x 157 x 193 61 x 91.4 x 91.4 66 x 91.4 x 100 67.2 x 157.5 x 106.7
(26 x 62 x 76) up to (24 x 36 x 36) : (26 x 36 x 39.4), (26.5 x 62 x 42) for
389 x 213 x 1,082 61 x 91.4 x 121.9 66 x 91.4 x 135 42" chamber; 67.2 x
(153 x 84 x 426), (24 x 36 x 48) : (26 x 36 x 53.1), 157.5 x 193 (26.5 x
80 sizes 61 x 91.4 x 152.4 66 x 91.4 x 155 62 x 76) for 72"
(24 x 36 x 60) (26 x 36 x 61) chamber
VOLUME,
m3 (ft3) 2-91 (70-3, 168), 0.52 (18) : 0.61 (21.5), 1.1 (40),
80 sizes 0.70 (24) : 0.83 (29.3), 2 (71)
0.87 (30) 0.96 (33.7)
LOADING Cart (pit mount) * See footnote ** Transfer cart Loading cart
Steam flush-
pressure pulse Select up to 10 psig Select up to 10 psig NA NA
CONTROLLER Nonproprietary open Nonproprietary open Automatic Automatic
platform PLC; modem platform PLC; modem
RECORDER 20-column thermal 20-column thermal Strip Strip
printer; optional printer; optional
chart recorder chart recorder
DOORS Single or double *** Single or double † Single or double Single or double
Operation Manual or power Manual or power Power Power
INSTALLATION
Cabinet enclosed Available Yes Yes No
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 23
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 110-120, 1-phase, 110-120, 1-phase, 120 120
50/60 Hz, 15 A 50/60 Hz, 15 A
Steam flush-
pressure pulse,
VAC Selectable 0-10 psig Selectable 0-10 psig NA NA
and 0-27 Hg and 0-27 Hg
PLANNING & PURCHASE
List price,
std configuration $120,000-600,000+ $60,000-180,000 Not specified Not specified
Warranty 1 year, parts and 1 year, parts and 1 year, parts and 1 year, parts and
labor; 15 years, labor; 15 years, labor; 15 years, labor; 15 years,
pressure vessel pressure vessel pressure vessel pressure vessel
Fiscal year March to February March to February January to December January to December
OTHER SPECIFICATIONS Nonproprietary and Nonproprietary and Automatic controller Automatic controller
commercially avail- commercially avail- available with available with
able piping compo- able piping compo- strip recorder; strip recorder;
nents and PLC-based nents and PLC-based computer-controlled computer-controlled
control systems; control systems; liquid exhaust; liquid exhaust;
cGMP features and cGMP features and supervisor control supervisor control
sanitary 3A con- sanitary 3A con- for cycle lockout; for cycle lockout;
struction available; struction available; RS232 serial port RS232 serial port
effluent decontamin- effluent decontamin- for data logger. for data logger.
ation features cy- ation features cy- Meets requirements Meets requirements
cle; vacuum leak- cle; vacuum leak- of ASME, CSA, and of ASME, CSA, and
test cycle; filter test cycle; filter UL 544. UL 544.
sterilization in sterilization in
place cycle; special place cycle; special
One-Step stopper One-Step stopper
sterilization and sterilization and
drying cycle; air drying cycle; air
over pressure or over pressure or
rapid cooling water rapid cooling water
cascade cycles; cascade cycles;
water-conserving water-conserving
closed-loop vacuum. closed-loop vacuum.
24 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Not specified Not specified Yes Yes
AIR REMOVAL Gravity or vacuum Gravity or vacuum Gravity Gravity
CHAMBER SIZES
W x H x D, cm (in) 40 (dia) x 60 30 (dia) x 50 25 x 45 35 x 52
(15.7 x 23.6) : (11.8 x 19.7) : (9.9 x 17.7) (13.8 x 20.5)
50 (dia) x 70 40 (dia) x 60
(19.7 x 27.6) (15.7 x 23.6) :
50 (dia) x 70
(19.7 x 27.6)
VOLUME,
m3 (ft3) 0.075 (2.6) : 0.135 0.035 (1.2) : 0.075 0.023 (0.81) 0.05 (1.8)
(4.8) (2.6) : 0.135 (4.8)
CHAMBER MATERIAL Stainless steel Stainless steel AISI 304 stainless AISI 304 stainless
steel steel
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Automatic Automatic Automatic Automatic
INSTALLATION
Cabinet enclosed Yes Yes No No
Recessed in wall No No No No
Pit mounted Yes Yes Floor mounted Floor mounted
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 25
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 230, 50 Hz; 230, 50 Hz; 120, 240 : 220/380
400, 3-phase 400, 3-phase 120, 220, 240
Steam flush-
pressure pulse,
VAC NA NA NA NA
26 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Yes Yes Yes Yes
AIR REMOVAL Gravity Gravity Vacuum Fractionated pre-
vacuum and post-
drying vacuum
CHAMBER SIZES
W x H x D, cm (in) 31 x 29 34.5 x 65 40 x 60 32 x 34 x 63
(12.2 x 11.4) (13.6 x 25.6) : (15.7 x 23.6), (12.6 x 13.4 x 24.8)
50 x 80 50 x 70
(19.7 x 31.5) (19.7 x 27.6)
VOLUME,
m3 (ft3) 0.023 (1) 0.065 (2.3) : 0.075 (2.6), 0.068 (2.4)
0.14 (4.9) 0.14 (4.9)
CHAMBER MATERIAL Aluminum/AISI 304 AISI 304 stainless AISI 316 stainless Stainless steel V4A,
stainless steel steel steel material no. 1.4571
Steam flush-
pressure pulse NA NA Optional NA
CONTROLLER Semiautomatic/ Automatic Automatic Automatic
automatic
RECORDER No Optional Optional Upon request
INSTALLATION
Cabinet enclosed No No No Enclosed
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 27
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 110, 220, 240 110, 220, 240 220/380 NA
Steam flush-
pressure pulse,
VAC NA NA Optional NA
28 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
VOLUME,
m3 (ft3) 0.31 (11) 0.2 (7.1), 0.315 0.071 (2.52) 0.16 (5.1) :
(11.1) 0.25 (8.7)
CHAMBER MATERIAL Stainless steel V4A, 321 grade stainless 316L stainless steel 316L stainless steel
material no. 1.4571 steel
Vacuum cycle Not specified 100-137 (212-278.6) 121-134 (250-273) 121-134 (250-273)
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Automatic Microprocessor Microprocessor Microprocessor
INSTALLATION
Cabinet enclosed Enclosed Not specified Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 29
Healthcare Product Comparison System
Vacuum models, VAC 230/400, 40 kW 220/240, 50 Hz; Depends on system Depends on system
415 VAC, 3-phase
Steam flush-
pressure pulse,
VAC NA NA NA NA
Delivery time, ARO 2-3 months 8-12 weeks Not specified Not specified
Training 2-3 days Not specified Not specified Not specified
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS None specified. Pulsed vacuum or Menu-guided dialogue Meets requirements
pre-/post-air system; graphics of 89/336/CEE,
ballast option; displayed in 89/392/CEE, and
protected liquid real time. Meets EN 285.
ring pump; steam requirements of
generator in 89/336/CEE,
constant standby for 89/392/CEE, and
faster cycle times; EN 285.
diagnostic system.
30 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
WHERE MARKETED Worldwide, except Worldwide, except Worldwide, except Africa, Asia,
USA USA USA Europe, South
America
CHAMBER SIZES
W x H x D, cm (in) 90 x 144 x [120, 67 x 67 x [63, 99, 68 x 120 x [106, 40 x 40 x 60 (15.7 x
240, 360, 480] 129, 173.5, 200] 136, 206] (26.8 x 15.7 x 23.6) :
(35.4 x 56.7 x . (62.4 x 26.4 x 47.2 x [41.7, 53.4, 60 x 60 x 60 (23.6 x
[47.2, 94.5, 141.7, [24.8, 39, 50.8, 81.1]) 23.6 x 23.6) :
189]) 68.3, 78.7]) 60 x 60 x 90 (23.6 x
23.6 x 35.4) :
60 x 60 x 120 (23.6
x 23.6 x 47.2) :
60 x 90 x 120 (23.6
x 35.4 x 47.2)
VOLUME,
m3 (ft3) 1.55 (54.7) : 0.28 (9.9) : 0.86 (30.5) : 0.14 (4.9) : 0.15
3.1 (109.5) : 0.44 (15.6) : 1.1 (39) : (5.3) : 0.31 (10.9)
4.6 (162.4) : 0.58 (20.6) : 1.67 (59.5) : 0.45 (15.9) :
6.2 (218.9) 0.77 (27.3) : 0.61 (21.5) :
0.89 (31.6) 0.90 (31.8)
CHAMBER MATERIAL 316L stainless steel 316L stainless steel 316L stainless steel AISI 316 T1
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Microcomputer Microcomputer Microcomputer Automatic
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 31
Healthcare Product Comparison System
Vacuum models, VAC Depends on system Depends on system Depends on system 380
Steam flush-
pressure pulse,
VAC NA NA NA NA
Warranty Not specified Not specified Not specified 1 year, parts and
labor
Delivery time, ARO Not specified Not specified Not specified 3-4 months
Training Not specified Not specified Not specified Not specified
Year first sold Not specified Not specified Not specified 1990
Number installed
USA/worldwide Not specified Not specified Not specified NA/500
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Dedicated to Dedicated to Dedicated to Customized programs
laboratory/hospital laboratory/hospital laboratory/hospital available; optional
use; complies with use; complies with use; complies with automatic loading/
EEC directives. EEC directives. EEC directives. unloading. Meets
requirements of CEN,
DIN, IEC, ISO, TUV,
and VDE.
32 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
FDA CLEARANCE No No No No
CE MARK (MDD) Yes Yes No No
AIR REMOVAL Gravity Vacuum pump Gravity Vacuum
CHAMBER SIZES
W x H x D, cm (in) 40 x 60 (15.7 x 40 x 60 (15.7 x 47 (dia) x 60 47 x 47 x 70 (18.5
23.6) 23.6) (18.5 x 23.6), x 18.5 x 27.6),
29 (dia) x 45 47 x 47 x 90 (18.5
(11.4 x 17.7) x 18.5 x 35.4),
47 x 47 x 140
(18.5 x 18.5 x 55.1)
VOLUME,
m3 (ft3) 0.075 (2.6) 0.075 (2.6) 0.1 (3.5), 0.2 (7),
0.03 (1.06) 0.22 (7.8),
0.3 (10.6); other
volumes by request
CHAMBER MATERIAL Stainless steel Stainless steel 316L stainless steel 316L stainless steel
Steam flush-
pressure pulse 1 3 Gravity By pump
CONTROLLER Microprocessor Microprocessor Semiautomatic Auto touchscreen
INSTALLATION
Cabinet enclosed Floor mounted Floor mounted Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 33
Healthcare Product Comparison System
Vacuum models, VAC NA 230, 50 Hz, 3-phase 110, 120, 220, 240, 110, 120, 220, 240,
380, 441 380, 441
Steam flush-
pressure pulse,
VAC Not specified Not specified NA NA
Delivery time, ARO 2-3 weeks 2-3 weeks 8-10 weeks 8-12 weeks
Training No special training No special training 1 day, on-site 2 days, on-site
needed needed
Year first sold 1994 1998 1963 1963
Number installed
USA/worldwide Not specified/1,310 Not specified/695 NA/340 NA/1,120
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Full automatic Full automatic Temperature con- All programs
control by micro- control by micro- trolled; optional changeable on touch-
processor; digital processor; digital gas-heated, external screen. Meets
display for display for steam supply. requirements of
programmable programmable Meets requirements Health Ministry of
temperature and temperature and of Health Ministry Chile (ISP).
time parameters; time parameters; of Chile (ISP).
sterilization sterilization
temperature and temperature and
time. time; final vacuum
and drying time;
maintenance-free
vacuum pump; 0.22 µm
filter at air-intake
line.
34 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 38.7 x 38.1 x 66 20 sizes from 35 (dia) x 62.5 50 (dia) x 54
(15.3 x 15 x 26) 40.6 x 40.6 x 66 (13.8 x 24.6) (19.7 x 21.3) :
(16 x 16 x 26) to 50 (dia) x 77
154.9 x 218.4 x (19.7 x 30.3) :
218.4 (61 x 86 x 86) 50 (dia) x 102
and larger custom (19.7 x 40.2)
VOLUME,
m3 (ft3) 0.08 (2.8) 0.11-7.4 (3.9-261.1) 0.06 (2.1) 0.1 (3.7) :
and up to 17 (600) 0.15 (5.3) :
custom 0.2 (7)
CHAMBER MATERIAL Stainless steel 316L stainless steel 316L stainless steel 316L stainless steel
chamber and door;
304 stainless steel
jacket
LOADING Removable bin/tray Shelving, cart, Top Front
transfer carriage **
TEMP RANGE, °C (F)
Gravity cycle 121-130.6 (250-267) 121-135 (250-275), 105-138 105-138
opt 70-135 (160-275) (221-280) (221-280)
low temperature
Vacuum cycle NA 121-135 Optional Optional
(250-275)
Steam flush-
pressure pulse NA 1-6 PREVACS Optional Optional
CONTROLLER Manual Microcomputer and Microprocessor, Microprocessor,
Pri-Matic Control Tactrol Tactrol
RECORDER Optional 24 hr temp Thermal printer, Printer option Printer option
recorder 24-character
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 35
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 208/240, 50/60 Hz 110-120, 50/60 Hz, Not specified * Not specified
10 A, 1-phase (3, 6 kW) (7, 10.5 kW : 10.5
kW : 10.5-21 kW) *
Vacuum models, VAC NA Additional circuits NA Not specified
may be required for (7, 10.5 kW : 10.5
vacuum pumps and kW : 10.5-21 kW) *
boilers
Steam flush-
pressure pulse,
VAC NA NA Optional Optional
Delivery time, ARO 4 weeks 14-120 days 6-8 weeks 8-10 weeks
Training Not specified Included 1 day 1 day
Fiscal year January to December January to December April to March April to March
OTHER SPECIFICATIONS Meets requirements Liquid cycle with Managed by Managed by
of ASME Boiler and auto-compensating Priorclave's Tactrol Priorclave's Tactrol
Pressure Vessel slow exhaust; low- microprocessor sys- microprocessor sys-
code. temp flowing steam tem. Complies with tem. Complies with
models available; all relevant all relevant
microcomputer con- European Directives European Directives
trol package with and MDD. and MDD.
cycle-advance; non-
proprietary replace-
ment parts; optional
authorized operator
security, custom
control packages,
and custom vessel
size or design
features. Meets
requirements of
ASME, CRN, ETL, FDA,
and ISO 9001:2000.
36 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
EV 100 : EV 150 EX V100 Top Loader EX V150 Top Loader RS 230 : RS 350 :
RS 450 : RS 700
WHERE MARKETED Worldwide, except Africa, Asia, India, Africa, Asia, India, Worldwide, except
USA South America South America USA
FDA CLEARANCE No No No No
CE MARK (MDD) Yes No No Yes
AIR REMOVAL Gravity or vacuum Gravity Not specified Gravity; vacuum
optional
CHAMBER SIZES
W x H x D, cm (in) 50 (dia) x 50 50 (dia) x 50 50 (dia) x 74 58 x 60 x 60 (22.8 x
(19.7 x 19.7) : (19.7 x 19.7) (19.7 x 29.1) 23.8 x 23.8) :
50 (dia) x 74 58 x 60 x 90 (22.8 x
(19.7 x 29.1) 23.8 x 35.4) :
67.5 x 75.5 x 90
(26.5 x 29.7 x 35) :
67.6 x 75.5 x 136
(26.5 x 29.7 x 53.5)
VOLUME,
m3 (ft3) 0.1 (3.5) : 0.1 (3.5) 0.1 (3.5) 0.23 (8.1) :
0.15 (5.3) 0.35 (12.4) :
0.45 (16.1) :
0.69 (24.4)
CHAMBER MATERIAL 316L stainless steel 316L stainless steel 316L stainless steel 316L stainless steel
Steam flush-
pressure pulse Optional Optional Optional Optional
CONTROLLER Microprocessor, Automatic digital Automatic digital Microprocessor,
Tactrol Tactrol
RECORDER Printer option Recorder option Recorder option Printer option
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 37
Healthcare Product Comparison System
EV 100 : EV 150 EX V100 Top Loader EX V150 Top Loader RS 230 : RS 350 :
RS 450 : RS 700
SUPPLY STEAM PRESS,
kg/cm2 (psig) Not specified Yes (amount not Not specified Not specified
specified)
ELECTRICAL POWER
Gravity models, VAC Not specified Not specified Not specified * Not specified
(7, 10.5 kW) * (7-10.5 kW) * (7-10.5 kW) (10.5 kW : 16 kW :
16-42 kW) *
Vacuum models, VAC Not specified Not specified Not specified Not specified
(7-10.5 kW) * (7-10.5 kW) * (10.5 kW : 16 kW :
16-42 kW) *
Steam flush-
pressure pulse,
VAC Optional Optional Optional Optional
Delivery time, ARO 6-8 weeks 8-10 weeks 8-10 weeks 10-12 weeks
Training 1 day 1 day 1 day 2 days
Fiscal year April to March April to March April to March April to March
OTHER SPECIFICATIONS Managed by None specified. None specified. Managed by
Priorclave's Tactrol Priorclave's Tactrol
microprocessor sys- microprocessor sys-
tem. Complies with tem. Complies with
all relevant all relevant
European Directives European Directives.
and MDD.
38 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
VOLUME,
m3 (ft3) 0.16 (5.6), 0.40 0.33-0.6 Ranges from 0.041 (1.45)
(14.1) (11.7-21.2), varies 0.24 (8.5) to
56.61 (2,000)
CHAMBER MATERIAL 304L or 316L stain- 316 or 321 stainless 316L stainless steel 304 stainless steel
less steel steel
LOADING Trays, trolley, and Front loading, External carriages * Casters attached
transfer carriage sliding door **
TEMP RANGE, °C (F)
Gravity cycle 115-121 (239-249.8) 100-138 (212-280) Not specified NA
Vacuum cycle 121-136 100-138 (212-280) 60 (140), 115 (230), 121-132 (250-270)
(249.8-276.8) 121 (250), 134 (273)
Steam flush-
pressure pulse Precondition *** NA NA NA
CONTROLLER Microprocessor Automatic Automatic Omron PLC Automatic
(Mitsubishi) with touchscreen
RECORDER Digital strip chart Optional Strip, data logger, None
or printer touchscreen recorder
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 39
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 220, 380 120 120/210/240/380/415 NA
(for all models)
Vacuum models, VAC 220, 380 Not specified 120/210/240/380/415 110, 120, 220, 240
(for all models)
Steam flush-
pressure pulse,
VAC 220, 380 NA NA NA
Delivery time, ARO 8-12 weeks 20 weeks ~8-16 weeks Not specified
Training Not specified 1 day See footnote * Not specified
40 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Not specified Yes Not specified Yes
AIR REMOVAL Vacuum, magnetic Gravity, magnetic Gravity, magnetic Gravity, magnetic
valve, steam trap valve valve valve
CHAMBER SIZES
W x H x D, cm (in) 37 (dia) x 74 24 (dia) x 45 30 (dia) x 67 30 (dia) x 67
(14.6 x 29.1) (9.4 x 17.7) (11.8 x 26.8) (11.8 x 26.8)
VOLUME,
m3 (ft3) 0.08 (2.83) 0.02 (0.71) 0.048 (1.69) 0.048 (1.69)
CHAMBER MATERIAL 304 stainless steel 304 stainless steel 304 stainless steel 304 stainless steel
SA 240
Steam flush-
pressure pulse NA NA NA NA
CONTROLLER Automatic Automatic Automatic Automatic
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
Recessed in wall Not specified Not specified Not specified Not specified
Pit mounted Floor mounted Floor mounted Floor mounted Floor mounted
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 41
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC NA 110, 120, 220, 240 : 110, 120, 220, 240 120, 208, 230
120, 208, 230
Steam flush-
pressure pulse,
VAC NA NA NA NA
Delivery time, ARO Not specified Not specified Not specified Not specified
Training Not specified Not specified Not specified Not specified
Year first sold Not specified Not specified Not specified Not specified
Number installed
USA/worldwide Not specified Not specified Not specified Not specified
Fiscal year Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Safety valve; elec- Safety valve; door Safety valve; door Safety valve; door
tronic limiter; lamp; door switch; lamp; limiter; lamp; handle switch;
weighs 325 kg weighs 47 kg weighs 69 kg door switch;
(717 lb). (103 lb); MLS-2420U (152 lb). weighs 69 kg
also has handle (152 lb).
switch.
42 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 30 x 30 x [60, 90] 60 x 60 x [60, 90, 90 x 60 x [90, 120, 40.6 x 40.6 x 66
(11.8 x 11.8 x 120] (23.6 x 23.6 x 180] (35.4 x 23.6 x (16 x 16 x 26),
[23.6, 35.4]) [23.6, 35.4, 47.2]), [35.4, 47.2, 70.9]) 66 x 66 x 66
90 x 60 x [90, 120, (26 x 26 x 26),
180] (35.4 x 23.6 x 66 x 66 x 121.9
[35.4, 47.2, 70.9]) (26 x 26 x 48),
50.8 x 50.8 x 96.5
(20 x 20 x 38),
61 x 91.4 x 91.4
(24 x 36 x 36) **
VOLUME,
m3 (ft3) 0.06 (2.1), 0.22 (7.7), 0.33 0.49 (17.3), 0.51 (18),
0.10 (2.8) (11.7), 0.44 (15.5), 0.65 (22.9), 0.68 (24),
0.49 (17.3), 0.65 0.98 (34.6) 0.85 (30)
(22.9), 0.98 (34.6)
CHAMBER MATERIAL AISI 316L chrome AISI 316L chrome AISI 316L chrome Nickel-clad steel
nickel steel nickel steel nickel steel
Steam flush-
pressure pulse NA NA NA Adjustable temp
CONTROLLER Automatic Automatic Automatic Computer control
INSTALLATION
Cabinet enclosed Yes Yes Yes Not specified
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 43
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 230/400, 50 Hz 230/400, 50 Hz 230/400, 50 Hz 120
Steam flush-
pressure pulse,
VAC NA NA NA Adjustable pressure,
vacuum, and temp
PLANNING & PURCHASE
List price,
std configuration Not specified Not specified Not specified $15,000-150,000
Warranty 1 year, parts and 1 year, parts and 1 year, parts and 1 year, parts and
labor labor labor labor
Delivery time, ARO 12-16 weeks 12-16 weeks 12-16 weeks 6-8 weeks
Training 1 day on-site 1 day on-site 1 day on-site Not specified
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Control panel with Control panel with Control panel with Air pressure; jacket
integrated LCD; integrated LCD; integrated LCD; cooldown; water-
optional central optional central optional central spray cooldown;
data administra- data administra- data administration built according to
tion with PC and tion with PC and with PC and bar-code UL guidelines.
bar-code reader. bar-code reader. reader. Meets
Meets requirements Meets requirements requirements
of CE, DIN, EN, ISO, of CE, DIN, EN, ISO, of CE, DIN, EN, ISO,
and TUV. and TUV. and TUV.
44 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Not specified Not specified Not specified Not specified
AIR REMOVAL Steam flush-pressure Steam flush-pressure Gravity only or Vacuum and gravity
pulse, vacuum and pulse, vacuum and vacuum and gravity combination
gravity gravity combination
CHAMBER SIZES
W x H x D, cm (in) 66 x 66 x 99.1 66 x 95.3 x 91.4 40.6 x 40.6 x 66 66 x 157.5 x 106.7
(26 x 26 x 39), (26 x 37.5 x 36), (16 x 16 x 26), (26 x 62 x 42),
66 x 66 x 125 66 x 95 x 121.9 50.8 x 50.8 x 96.5 66 x 157.5 x 193
(26 x 26 x 49), (26 x 37.5 x 48), (20 x 20 x 38) (26 x 62 x 76)
66 x 66 x 155 66 x 95 x 152.4
(26 x 26 x 61) (26 x 37.5 x 60)
VOLUME,
m3 (ft3) 0.43 (15.2), 0.579 (20.4), 0.109 (3.85), 1.1 (40),
0.54 (19.1), 0.764 (27), 0.249 (8.79) 2 (71)
0.68 (23.8) 0.957 (33.8)
CHAMBER MATERIAL Stainless steel Stainless steel Stainless steel Duplex alloy
LOADING Rack and shelves or Rack and shelves or Rack and shelves or Floor cart
car and carriage car and carriage car and carriage
TEMP RANGE, °C (F)
Gravity cycle 121-132 121-132 121-132 121-132
(250-270) (250-270) (250-270) (250-270)
Steam flush-
pressure pulse 121-132 (250-270) 121-132 (250-270) 121-132 (250-270) NA
CONTROLLER Automatic Automatic Automatic Automatic
INSTALLATION
Cabinet enclosed Yes Yes Yes No
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 45
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC NA NA 120 VAC 120
Vacuum models, VAC Vacuum pump 208/240, Vacuum pump 208/240, 120 VAC 120
50/60 Hz, 6A 3-phase 50/60 Hz, 6A 3-phase
or 480, 50/60 Hz, or 480, 50/60 Hz,
34 3-phase 34 3-phase
Steam flush-
pressure pulse,
VAC Yes Yes NA NA
Warranty 1 year, parts and 1 year, parts and 1 year, parts and 1 year, parts and
labor; 2 years, labor; 2 years, labor; 2 years, labor; 15 years,
gasket; 15 years, gasket; 15 years, gasket; 15 years, pressure vessel
pressure vessel pressure vessel pressure vessel
Fiscal year April to March April to March April to March April to March
OTHER SPECIFICATIONS Touch-sensitive Touch-sensitive Touch-sensitive Printer and paper
control; printer control; printer control; printer take-up; cycle
and paper take-up; and paper take-up; and paper take-up; safeguards to
elliptical chamber; manual hinged-door footpedal-activated prevent incorrect
cycle safeguards to locking mechanism; vertical sliding temperature
prevent incorrect elliptical chamber; door for hands-free parameters; cycle
temperature cycle safeguards to loading and unload- lockout against
parameters; prevent incorrect ing; cycle unauthorized use;
cycle lockout temperature safeguards to pre- automatic utility
against unauthorized parameters; vent incorrect tem- shutdown. Meets
change; automatic cycle lockout perature parameters; requirements of
utility shutdown. against unauthorized cycle lockout ASME, CSA, EMC
Meets requirements change; automatic against unauthorized Directive, ETL, and
of ASME, CSA, EMC utility shutdown. change; automatic Low Voltage
Directive, ETL, Meets requirements utility shutdown. Directive.
Low Voltage Direc- of ASME, CSA, EMC Meets requirements
tive, seismic Directive, ETL, of ASME, CSA, EMC
preapproval. Low Voltage Direc- Directive, ETL,
tive, seismic Low Voltage Direc-
preapproval. tive, seismic
preapproval.
46 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 40.6 x 40.6 x 66 24.5 x 32 32.5 (dia) x 41 x 41 x 73
(16 x 16 x 26), (9.6 x 12.6) 63.5 (H) (16 x 16 x 29) :
50.8 x 50.8 x 96.5 (12.8 x 25) 51 x 51 x 97
(20 x 20 x 38) (20 x 20 x 38.2) :
61 x 61 x 93
(24 x 24 x 36) :
61 x 61 x 123
(24 x 24 x 48) :
61 x 61 x 153
(24 x 24 x 60)
VOLUME,
m3 (ft3) 0.109 (3.85), 17 L 0.053 (1.76) 0.12 (4.2) :
0.249 (8.79) 0.25 (8.8) :
0.35 (11.1) :
0.45 (15.9) :
0.57 (20.1)
CHAMBER MATERIAL Stainless steel BO4 stainless steel Stainless steel 316L stainless steel
LOADING Rack and shelves or Not specified Basket Transfer cart, rack,
car and carriage and shelves
TEMP RANGE, °C (F)
Gravity cycle 121-132 NA 105-132 (221-270) 70-138 (158-280)
(250-270) for sterilization **
Steam flush-
pressure pulse 121-132 (250-270) NA NA Yes
CONTROLLER Automatic Automatic Automatic, micro- Automatic, optional
processor controlled PC software
RECORDER Printer Digital strip chart Optional Printer or optional
strip chart
INSTALLATION
Cabinet enclosed Yes Yes No Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 47
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 120 230, 50/60 Hz 110-240 120/230/380
Steam flush-
pressure pulse,
VAC NA NA NA Not specified
Warranty 1 year, parts and 5 years, parts 1 year 1 year, parts and
labor; 2 years, labor; 15 years,
gasket; 15 years, pressure vessel
pressure vessel
Delivery time, ARO 4 weeks 3-4 weeks 3-4 weeks Not specified
Training On-site in-service 2 days on-site Not specified Not specified
Fiscal year April to March January to December Not specified Not specified
OTHER SPECIFICATIONS Touch-sensitive Meets requirements None specified. Electric steam
control; printer of ETL and TUV. generator available
and paper take-up; for all models;
cycle safeguards to customized sizes
prevent incorrect available. Meets
temperature requirements of
parameters; cycle ASME, TUV, and UL.
lockout against un-
authorized use;
automatic utility
shutdown. Meets re-
quirements of ASME,
CSA, EMC Directive,
ETL, Low Voltage
Directive, seismic
preapproval.
48 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 61 x 91 x 93 Various sizes 75 x 45 x 40 170 x 61 x 91
(24 x 36 x 36) : available (29.5 x 17.7 x (66.9 x 24 x 35.8) :
61 x 91 x 123 15.7); 125 x 45 x 40 150 x 68 x 108
(24 x 36 x 48) : (49.2 x 17.7 x (59.1 x 26.8 x 42.5)
61 x 91 x 153 15.7); 120 x 61 x 91 : 150 x 68 x 148
(24 x 36 x 60) : (47.2 x 24 x 35.8) (59.1 x 26.8 x 58.3)
61 x 91 x 183
(24 x 36 x 72)
VOLUME,
m3 (ft3) 0.52 (18.4) : From 0.05 (1.8) to 0.13 (4.6), 1.0 (35.3),
0.68 (24) : 4 (141.2) 0.22 (7.8), 1.2 (42.4),
0.85 (30) : 0.6 (21.2) 1.5 (53)
1.01 (36)
CHAMBER MATERIAL 316L stainless steel AISI 316 Ti or 316L 304 stainless steel 304 stainless steel
stainless steel
LOADING Transfer cart, rack, Shelving or carts, Transfer carriage Transfer cart/
and shelves transfer carriage carriage
TEMP RANGE, °C (F)
Gravity cycle 70-138 (158-280) 90/135 (194/275) NA NA
Steam flush-
pressure pulse Yes 116/135 (240/275) NA NA
CONTROLLER Automatic, optional PC with touchscreen Automatic Automatic
PC software
RECORDER Printer or optional Printer and inform- Digital strip chart Digital strip chart
strip chart atic backup
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 49
Healthcare Product Comparison System
ELECTRICAL POWER
Gravity models, VAC 120/230/380 220/380-400 NA NA
Steam flush-
pressure pulse,
VAC Not specified 220/380-400 NA NA
Delivery time, ARO 90-120 days Not specified 3-8 weeks 3-5 weeks
Training Classes and on-site Not specified 1-2 days on-site 1-2 days on-site
available
Year first sold 1960 1986 2002 1985
Number installed
USA/worldwide 100/5,000 0/~500 Not specified 2
Fiscal year Not specified January to December January to December January to December
OTHER SPECIFICATIONS Electric steam Custom cycles and None specified. None specified.
generator available processes; custom
for all models; sizes. Meets
customized sizes requirements of
available. Meets DIN 58946, EN 285,
requirements of ISO 9001, NFS 90320,
ASME, TUV, and UL. and TUV. Chamber
manufacturing meets
requirements of EN
97/23.
50 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Steam, Bulk
CHAMBER SIZES
W x H x D, cm (in) 120 x 61 x 91 65 x 65 x 66
(47.2 x 24 x 35.8) : (25.6 x 25.6 x 26)
170 x 68 x 108 : 65 x 65 x 96
(66.9 x 26.8 x 42.5) (25.6 x 25.6 x 37.8)
: 210 x 68 x 148 : 65 x 65 x 126
(82.7 x 26.8 x 58.3) (25.6 x 25.6 x 49.6)
: 65 x 65 x 156
(25.6 x 25.6 x 61.4)
: 40 x 56 x 65
(15.7 x 22 x 25.6) **
VOLUME,
m3 (ft3) 0.6 (21.2), 0.08-0.65
1.0 (35.3), (2.67-21.67)
2.5 (88.3)
Steam flush-
pressure pulse NA NA
CONTROLLER Automatic Automatic, micro-
processor/computer ***
RECORDER Digital strip chart 3- or 6-channel
point printer;
screen recorder
DOORS Single or double Single and double
Operation Manual or motorized Automatic and manual
(heated) †
INSTALLATION
Cabinet enclosed Yes Yes
©2004 ECRI. Duplication of this page by any means for any purpose is prohibited. 51
Healthcare Product Comparison System
Steam flush-
pressure pulse,
VAC NA NA
52 ©2004 ECRI. Duplication of this page by any means for any purpose is prohibited.