October 2002

Sterilizing Units, Ethylene Oxide

Scope of this Product Comparison
This Product Comparison covers gas sterilizers
that use 100% ethylene oxide (EtO) or other gas
mixtures, such as EtO/carbon dioxide (CO2) or
EtO/hydrochlorofluorocarbon (HCFC). All listed
units release the sterilants automatically. Com-
bination steam/EtO sterilizers, separate aera-
tors, and EtO disposal systems are not included.
For information on other sterilizers, see the fol-
lowing Product Comparisons:
• Sterilizing Units, Plasma
• Sterilizing Units, Steam, Bulk
• Sterilizing Units, Steam, Tabletop
• Washer/Sterilizing Units
UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature System™
(UMDNS™):
• Sterilizing Units, Ethylene Oxide [13-740]
Devices that fall into the latter categories include most
plastic or rubber products, such as catheters, resusci-
tation bags, anesthesia masks, and most fiberoptic
instruments.
EtO sterilizers used in healthcare facilities can be
enclosed in a cabinet; mounted on a wall, on the floor,
or in a pit; recessed; or, in the case of one manufac-
turer’s units, placed on special racks as stand-alone
units. EtO sterilizers in hospitals are usually found in
the central supply area; however, in some hospitals,
they are also located elsewhere, such as in the operat-
ing room or in respiratory therapy areas.
Principles of operation
Like any other sterilant, EtO will not effectively kill
microorganisms protected in dried organic matter.
Therefore, the items to be sterilized are usually kept
moist until they are decontaminated. Before steriliza-
tion, they are cleaned of contamination, such as feces,

Purpose
EtO sterilizing units are used to sterilize medical
and surgical supplies and equipment. EtO (chemical
formula C2H4O), a colorless gas at room temperature
and atmospheric pressure, is flammable at concentra-
tions greater than 3% in air and liquefies at tempera-
tures below 52°F (11°C) and under pressure. It can be
used to sterilize non-heat-sensitive devices, as well as
those sensitive to excessive moisture or heat that would
be damaged by steam or liquid chemical sterilization.

225664 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org
Healthcare Product Comparison System
blood, and sputum, and are rinsed with distilled or
demineralized water to remove any detergent or tap-
water residues. They are then placed into packs (e.g.,
sealed plastic wrapping film, muslin wraps, steriliza-
tion containers) and loaded into baskets or carts, which
are placed in the sterilization chamber. (See the Prod-
uct Comparison titled STERILIZATION CONTAINERS.)
Hot or cold cycles are selected, depending on the de-
vices being sterilized.
Chambers are heated by electrical resistance or by
steam contained in a jacket surrounding the chamber.
Figure 1 shows a schematic of a steam-heated steril-
izer. The sterilization cycle usually consists of four
phases: conditioning, exposure (sterilizing), exhaust,
and air purge.
In the conditioning phase, a vacuum pump or water
ejector withdraws air from the chamber and allows
controlled amounts of moisture or steam to be released
by a chamber heating system, thereby raising the
relative humidity (RH). Typically, after humidifica-
tion, EtO or an EtO/diluent mixture is injected into the
chamber, starting the exposure (sterilizing) phase. The
chamber concentration of EtO varies from 450 to 1,200
mg/L of the chamber area, depending on the sterilizer.
In the exposure phase for systems operating at
positive pressure, chamber pressure may drop slightly
as EtO is absorbed by the items. Most sterilizers
detect these pressure drops and provide small
amounts of additional gas (gas makeups) to maintain
proper pressure and EtO concentration. Typically, if
three of these pressure drops occur, an alarm will
sound to alert for potential leaks.
In the exhaust phase, the vacuum system vents the
gas from the chamber to an exhaust drain and/or
directly to the outside of the building to reduce work-
ers’ exposure to EtO when the door is opened. Most
sterilizers then purge the chamber with fresh, filtered
air to prevent gas buildup from items degassing in the
chamber. The sterilized contents are then aerated to
remove EtO residue, in either a separate aerator or an
in-chamber aerator. If separate aerators are used, they
should be of the same capacity as the sterilizer or
larger.
Although the exact process is unknown, EtO is
thought to attack the RNA and DNA of the microor-
ganisms on the surfaces of the items to be sterilized.
It penetrates the sealed pack and sterilizes the goods
within. A number of variables determine whether
sterilization is successful, including EtO concentra-
tion, exposure time, temperature, and RH. RH is
important because moisture enhances EtO penetra-
tion of microbial cells/spores and aids the chemical
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Localized
Ventilation
Air
Inlet
System
Steam Bacteria-Retentive
Inlet Filter
Gas Conditioner
Sterilizing
Chamber
Vent
EtO
C613UN5A
Cylinder
Vacuum Pump
Figure 1. Schematic of an EtO sterilizer
alkylation process that kills the organisms. Extremely
dry organisms may not be destroyed in normal EtO
sterilization; therefore, dehydrated cells may require
presterilization treatments at 75% to 98% RH, pro-
longed EtO exposure time, and/or complete immersion
in water.
Because microbes vary in heat and moisture re-
quirements, any materials to be sterilized should be
prehumidified by washing and surface drying (not in a
hot oven) or by exposure to moderately humid air (30%
RH). The chamber should be maintained at 30% to
100% RH during the sterilization cycle (Young 1986).
Exposure time depends on the temperature of the
chamber: as the temperature decreases, the required
exposure time increases. A typical warm sterilization
temperature is 120° to 145°F (49° to 63°C), with an
exposure time of one to two hours. Some units allow
the operator to select a warm or cold cycle, according
to the items being sterilized. Temperature-sensitive
devices, such as catheters, require lower temperatures
(80° to 131°F, or 27° to 55°C) to avoid damage or
degradation and therefore require longer exposure
times (five to six hours).
EtO is available diluted with CO2 or HCFC or in its
pure (100%) form. Whatever the form, the gas must be
handled carefully to protect the operators in the event
of an accident, but particular care must be taken in
storing, using, and disposing 100% EtO to prevent
explosion.

Regardless of the sterilant mixture, EtO mixtures
usually come in a tank or cylinder. Gas is released from
the tank or cylinder into the chamber through an open
solenoid valve, which closes when the chamber reaches
a certain pressure. 100% EtO usually comes in a car-
tridge; these containers, used for sterilizers whose
chambers are eight cubic feet or smaller, reduce the cost
and explosion hazard associated with storing large
cylinders of EtO over long periods. During sterilization,
the cartridge is automatically punctured within the
sterilizer and releases gas into the chamber after air is
evacuated from the chamber by the vacuum system.
Sterilization cycles and variables can be displayed
graphically by a circle-chart recorder or dual-pen re-
corder or alphanumerically by a microprocessor-con-
trolled data recorder. Some types of recorders also
provide the date and time and indicate the occurrence
of any problems that may adversely affect the steriliza-
tion cycle. If a recorder is not offered with the sterilizer,
the information may be digitally displayed on the con-
trol panel. A hard copy of each cycle should be kept.
Several features improve the safety of EtO sterili-
zation. Door-interlock systems prevent the steriliza-
tion cycle from beginning until the chamber door is
closed securely and keep the door from opening during
the cycle. Most sterilizers are also equipped with an
internal monitoring system that detects problems
(e.g., insufficient vacuum or gas concentration, tem-
perature problems, gas leaks) and alerts the operator.
The end-of-cycle buzzer alerts the operator that the
cycle is complete and that the chamber door should be
opened.
Another important safety feature is the localized
ventilation package, which reduces environmental
and employee EtO exposure when the sterilizer door
is opened or if, for example, a leak should occur in the
door gasket. EtO gas in the vicinity of the door is
drawn up into an exhaust hood located above the door
and then vented to the outside or to an emission-con-
trol system. It is also drawn up (through a flexible
hose) from the exhaust drain (which, in some steriliz-
ers, may contain water discharge from the vacuum
pump) to the hood. Instead of an exhaust hood, some
sterilizers have copper tubing ducts leading directly
outdoors. Many sterilizers have an automatic
overtemperature control.
Sterilizers can be pit mounted or floor mounted. In
pit-mounted models, the chamber floor is aligned with
the building floor to allow direct loading and unloading
of processing carts. In floor-mounted models, a hydrau-
lic lift is provided at each door to raise and lower
processing carts for loading and unloading. Push-
button lift controls are included on the control panel.
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Ethylene Oxide
Reported problems
Although it is more costly and takes more time to
sterilize items than steam sterilization, EtO steriliza-
tion has been the most commonly used process for
sterilizing temperature- and moisture-sensitive medi-
cal devices and supplies in healthcare institutions.
However, specific problems are associated with the use
of EtO sterilizing units. EtO is a potent neurotoxin, a
known human carcinogen (classified under group I by
the International Agency for Research on Cancer), a
potential reproductive hazard, and an allergic sensi-
tizer. Acute overexposure causes conjunctival, skin,
and respiratory tract irritation as well as headache
and nausea. Skin contact from inadequately aerated
material can result in severe burns to workers and
patients. Chronic exposure can result in significant
toxicity to the nervous system and extremely high
exposures may result in decreased consciousness, cya-
nosis, and pulmonary edema.
The U.S. Occupational Safety and Health Admini-
stration (OSHA) published a standard on allowable
EtO exposure limits in 1984 and revised the standard
in 1988 (see Standards and Guidelines). The standard
places the permissible limit of occupational exposure
to EtO at 1 part per million (ppm) time-weighted
average for a normal eight-hour workday. In addition,
it specifies a 0.5 ppm “action level” (the point at which
a hospital must institute regular employee monitoring
and other safety measurements). The standard also
provides information concerning exposure control, em-
ployee training, medical surveillance, signs and label-
ing, emergency procedures, record keeping, and
monitoring frequencies. The revised edition of this
standard establishes a 5 ppm short-term excursion
limit, the amount of EtO exposure allowed over a
15-minute period. The amendment also includes moni-
toring and protection mandates for employers. Initial
exposure monitoring is required, consisting of worker-
breathing-zone air samples that are representative of
the 8-hour time-weighted average and 15-minute
short-term exposure of each employee. When expo-
sures exceed the action level or excursion limit, em-
ployers are required to repeat monitoring every three
months or as often as necessary to evaluate the situ-
ation. (For more information on EtO levels, see the
Product Comparison titled ETHYLENE OXIDE MONI-
TORS.) In addition, employers must develop written
plans for emergency EtO situations, such as leaks or
spills, and ways to “alert potentially affected employ-
ees of such occurrences promptly” (U.S. Department of
Labor 1988).
A recent study by LaMontagne and Kelsey (1997)
describes a widespread lack of understanding of the
3
Healthcare Product Comparison System
“alert” requirement among managers and variable in-
terpretation of this requirement by OSHA. In the
absence of clarity on this issue, some EtO-monitor
marketers have interpreted the requirement in favor
of their own interests, recommending expensive alarm
systems that comply with the OSHA standard. This is
a situation in which educational intervention could
improve health and safety and decrease costs to hospi-
tals to comply with the standard (LaMontagne and
Kelsey 1997).
Exposure to high levels of EtO has resulted from
malfunctioning valves, worn door gaskets, and defec-
tive door-interlock systems. According to one reported
problem, a malfunctioning solenoid valve allowed
high-pressure EtO gas to enter the chamber, and a
safety relief valve failed to open, causing a pressure
explosion. Valve failure can result from the deteriora-
tion of valve seal material caused by EtO or by the
buildup of contaminants such as dirt and polymers.
EtO will polymerize if it is left in contact with some
materials for extended periods; ECRI has had reports
of valve failures resulting from polymer buildup on
valve seals.
In another instance, EtO leaked because of an im-
properly adjusted door-interlock system that allowed
the sterilization cycle to run with the door only par-
tially sealed. Regular inspections and newer safety
features can help eliminate these kinds of problems.
When changing EtO cylinders, employees should
avoid exposure to both the vapor and the liquid forms
of EtO. The installation of a check or shutoff valve near
the disconnection point minimizes the release of EtO
from the supply line. However, such valves are not
foolproof. ECRI received a report of two hospital em-
ployees being sprayed with EtO from a 63.6 kg (140 lb)
cylinder after a valve had been turned completely to
the OFF position. Precautions that should be taken
when changing an EtO cylinder or conducting other
sterilizer maintenance include wearing a respirator
with suitable eye and face protection, wearing suitable
coveralls (preferably disposable) and neoprene gloves
to avoid skin exposure, and having an emergency
evacuation plan.
Dedicated exhaust and ventilation systems should be
carefully designed to avoid personnel exposure. EtO
sterilizers should be placed in isolated, well-ventilated
areas with controlled access. Exhaust lines should be
local and lead directly from the sterilizer door to an
exhaust drain and/or to the outside. The ventilation
system should be nonrecirculating, discharging air from
the space to the outdoors. With adequate engineering
controls and proper work techniques, exposures should
be well below the permissible exposure limit of 1 ppm.
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In certain situations, normally nonflammable mix-
tures may become explosive when mixed with air. For
example, one case involved an older portable EtO
sterilizer that did not exhaust to the outside. Leaks in
the pressure-relief valve and the gas-inlet piping al-
lowed gas to enter and accumulate in the cabinet
beneath the chamber, resulting in combustion and
explosion. The gas mixture apparently reached the
combustion point for EtO and air and was ignited
(probably by a spark from a relay or the purging
motor); investigators speculated that the EtO concen-
tration might have changed through selective diffusion
and loss of some of the nonflammable component.
EtO can adversely affect some materials after re-
peated sterilization. For example, rubber endotracheal
tubes soften and kink more easily, which could seri-
ously compromise a patient’s air exchange. Therefore,
a strict hospital quality-assurance program should be
instituted to ensure the integrity of all EtO-sterilized
items.
Chlorofluorocarbons (CFCs) have been mixed with
EtO to reduce its flammability; however, CFCs have
been found to deplete the Earth’s ozone layer. The
international ban on CFCs (under provisions of the
Clean Air Act of 1995) has encouraged many hospitals
to replace 12/88 EtO sterilizers with 100% EtO steril-
izers, although some larger sterilizers now use EtO-
CO2 or EtO-HCFC gas mixtures. Despite this
replacement, recent studies have questioned the effec-
tiveness of 100% EtO sterilization. There is some indi-
cation that a narrower safety margin exists for 100%
EtO sterilization than for 12% EtO diluent gas sterili-
zation (Alfa et al. 1996).
Purchase considerations
In general, there are four traditional methods used
to sterilize medical devices: pressurized steam, EtO,
gas plasma, and liquid germicides. Each method has
its limitations. Hospitals need to assess their current
sterilization/reprocessing protocols and evaluate cur-
rent and future needs before purchasing a sterilizer.
Plasma sterilization may be a cost-effective and
environmentally sound choice for low-temperature
sterilization. The process involves the generation of
reactive species that interact with cell membranes,
enzymes, or nucleic acids to destroy microorganisms
at or below 55°C (131°F). Currently marketed
plasma sterilizers employ a hydrogen peroxide gas
plasma in the sterilization process. Although the
liquid sterilants used in plasma sterilizers are listed
substances in the OSHA hazard communication
standard (29 CFR 1910.1200), safety features have
been devised to minimize the chance of exposing

operatorstotheconcentrated chemicals. The end prod-
ucts of plasma sterilization are not toxic, reducing
regulatory and safety concerns. Installation of a
plasma sterilizer is straightforward, with a low risk of
emission-related errors.
Because gas plasma technology is relatively new,
many medical devices were not developed with the gas
plasma sterilization method in mind, and many users
will have less experience with the process.
Although EtO units have larger chambers than gas
plasma sterilizers and thus can process more items at
once, EtO sterilization requires a longer cycle time and
10 to 16 hours of aeration time after processing to
eliminate toxic residues from the sterilized items.
These requirements can result in the removal of ster-
ilized items from use for up to 24 hours and may
require the purchase of additional inventory to meet
the demands of the hospital. The cost of maintaining
such an inventory is compounded by the costs associ-
ated with meeting federal regulations for emissions
and personnel safety.
Because of the potentially detrimental effects that
EtO can have on the environment, a number of regions
have enacted regulations to limit emissions from EtO
sterilizers. For healthcare facilities that are affected
by these regulations, the use of an EtO-emission-
abatement system may be the most desirable alterna-
tive. Currently available systems can effectively
reduce emissions by up to 99.9%, allowing healthcare
facilities that wish to continue using EtO sterilizers to
comply with even the most stringent environmental
regulations. In some emission-abatement systems,
EtO is broken down into CO2 and water through a
process called catalytic oxidation. Other emission-
abatement systems use a scrubbing method. Purchase
prices for EtO-emission-abatement systems vary de-
pending on the size and amount of EtO removed, with
systems typically costing between $15,000 and
$100,000. Reportedly, scrubbing costs less than cata-
lytic oxidation (MacNeal and Glaser 1997).
Cost containment
Installation costs for EtO sterilizers vary greatly.
Most suppliers assume the hospital will provide
plumbing, electricity, and ventilation before unit
installation; a hospital should be aware of the sup-
plier’s specific requirements. In addition, if an older
unit is being removed, it is important to remove and
properly dispose of any asbestos insulation used in
the unit and its interconnections. EtO sterilizers
typically require a steam line, a cold-water line, a
drain, a duct to the outside of the building, and one
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Sterilizing Units, Ethylene Oxide
or more dedicated electric lines. Other considerations
include the following:
• Current or pending changes in local regulations on
EtO or EtO diluent emissions
• Liability and cost issues associated with protecting
personnel from exposure to toxic sterilants
• Benefits and limitations of low-temperature sterili-
zation alternatives
Hospitals can purchase service contracts or service
on a time-and-materials basis from the supplier. Ser-
vice may also be available from a third-party organi-
zation. The decision to purchase a service contract
should be carefully considered. Purchasing a service
contract can ensure that preventive maintenance will
be performed at regular intervals, thereby eliminating
the possibility of unexpected maintenance costs. Also,
many suppliers do not extend system performance and
uptime guarantees beyond the length of the warranty
unless the system is covered by a service contract.
ECRI recommends that, to maximize bargaining
leverage, hospitals negotiate pricing for service con-
tracts before the system is purchased. As a guideline,
full-service contracts typically cost approximately 8%
to 12% of the sterilizer’s purchase price. Additional
service contract discounts may be negotiable for mul-
tiple-year agreements or for service contracts that are
bundled with contracts on other sterilizing equipment
in the department or hospital.
Stage of development
The earliest EtO sterilizers were produced in the
early 1950s. Newer EtO sterilizers have such features
as built-in safety devices, the ability to be modified
with additional safety components (e.g., door-interlock
systems, audible alarms), and microprocessor-control-
led sterilization cycles. In-chamber aeration is now
available with many sterilizers.
Since the manufacture of 12/88 EtO sterilizing
units has ceased under provisions of the Clean Air Act
of 1995, alternative technologies to EtO with CFCs
have become available. Aside from 100% EtO, EtO
with different stabilizing gases, such as CO2 or HCFC,
can be used in large-capacity, tank-supplied steriliz-
ers. The EtO-CO2 mixture consists of 8.5% EtO and
91.5% CO2. This is less expensive than EtO-HCFC but
requires pressure vessels that are rated for steam
sterilization because higher pressures (28 psi gauge)
are required. HCFCs are approximately 50-fold less
damaging to the Earth’s ozone layer than CFCs (Ru-
tala and Weber 1998). In the United States, HCFC
manufacturers will be subject to incremental produc-
tion restrictions starting in the year 2004. The U.S.
5
Healthcare Product Comparison System
Environmental Protection Agency will begin regula-
tion of HCFCs in the year 2015 and will ultimately
terminate their production in the year 2030. EtO-
HCFC mixtures are sold as drop-in replacements for
CFC-12 and are available in ratios of 8.6% EtO/91.4%
HCFC and 10% EtO/90% HCFC.
Alternative methods to EtO sterilization include
vapor-phase hydrogen peroxide and gas plasma ster-
ilization (see the Product Comparison titled STERILIZ-
ING UNITS, PLASMA); sterilization with ozone may be
available in the future.
For facilities located in areas that have EtO emis-
sion-limiting regulations, emission abatement sys-
tems are now available that can effectively reduce
emissions by up to 99.9%. However, the purchase and
operation of these systems can cost nearly as much as
a new EtO sterilizer.
Serious health risks to hospital personnel due to
EtO exposure have been addressed much more seri-
ously since the classification of EtO as a known car-
cinogen; consequently, EtO sterilizers are becoming
less favorable as a means of sterilization. However, due
to the difficulty of sterilizing heat- and moisture-sen-
sitive instruments, and due to the ready availability of
EtO sterilizing units, EtO sterilizers are still consid-
ered to be highly effective and will probably not be
phased out of the market for a few more decades.
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safety requirements for medical electrical systems.
Amendment 1 [standard]. IEC 60601-1-1-am1 (1995-
11). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 2. Collateral standard:
electromagnetic compatibility — requirements and
tests. IEC 60601-1-2 (2001-09). 2001.
International Organization for Standardization. Bio-
logical evaluation of medical devices — part 7: eth-
ylene oxide sterilization residuals [standard]. 1st
ed. ISO 10993-7. 1995.
Sterilization of health care products — biological
indicators — part 2: biological indicators for ethyl-
ene oxide sterilization [standard]. 1st ed. ISO
11138-2:1994. 1994.
National Institute for Occupational Safety and Health.
CIB-35-ethylene oxide. Evidence of carcinogenicity.
81-130.
Ethylene oxide sterilizers in health care facilities
[guideline]. 1989 Jul 13.
7
Healthcare Product Comparison System

Standards Association of Australia. Aeration cabinets Healthcare Hazardous Materials Management

(for use with ethylene oxide sterilizers) [standard].
AS 1862-1976. 1976.
University HealthSystem Consortium. Technology re-
port: hospital sterilization equipment. 1996 Nov.
U.S. Department of Health and Human Services. Food
and Drug Administration, Center for Devices and
Radiological Health. Ethylene oxide sterilization —
a guide for hospital personnel.
EtO phone home: the future of sterilization in hospi-
tals. 1990 Jul;3:1-9.
Ethylene oxide control technology I: occupational ex-
posure. 1990 Sep;3:1-9.
Ethylene oxide control technology II: environmental
protection. 1990 Oct;4:1-10.

U.S. Department of Labor. Occupational Safety and Healthcare Risk Control

Health Administration. Occupational exposure to
ethylene oxide: final standard. Fed Regist 1984 Jun Personnel exposure to ethylene oxide [risk analysis].
22;49(122):25734-809. 1996;3:Environmental issues:8.
Occupational exposure to ethylene oxide; final
standard. Fed Regist 1988:11414-38. Health Technology Trends

Special occupational hazard review with control Hospitals weigh options and costs in EtO sterilization.
recommendations — use of ethylene oxide as a ster- 1995 Feb;7(2):5-6.
ilant in medical facilities. NTIS No. PB-274-795.

Citations from other ECRI publications Supplier information

Health Devices
EPA withdraws EtO labeling requirements. 1984 Andersen
May;13(7):145-6.
Andersen Medical (Hong Kong) Ltd [266340]
Minimizing EtO exposure when changing gas cylin- Flat A 9/Fl Century Industrial Center
ders [User Experience Network™]. 1989 Jul- 33-35 Au Pui Wan St Fo Tan
Aug;18(7-8):290. Shatin
Hong Kong SAR
Problems related to EtO sterilization of infant oxygen
People’s Republic of China
hoods [User Experience Network™]. 1994
Phone: 852 20511655
Mar;23(3):99.
Fax: 825 28510586
Ethylene oxide sterilization: how hospitals can adapt E-mail: andmed@netvigator.com
to the changes [guidance article]. 1994 Internet: http://www.anpro.com
Dec;23(12):485-92.
Andersen Products Inc [101953]
Improperly connected ethylene oxide sterilizer supply Health Science Park
cylinder [hazard report]. 1994 Dec;23(12):493-4. 3202 Caroline Dr
Questions to ask about new sterilization technologies Haw River NC 27258-8710
[Talk to the specialist]. 1996 Oct;25(10):393-5. Phone: (336) 376-3000, (800) 523-1276
Fax: (336) 376-8153
Choosing a low-temperature sterilization technology E-mail: mailbox@anpro.com
[guidance article]. 1999 Nov;28(11):430-55. Internet: http://www.anpro.com
EtO-emission-abatement systems. 1999 Nov;28(11):437.
H W Andersen Products Ltd [266341]
Estimated life expectancy of medical devices [Talk to Davy Rd Industrial Estate
the specialist]. 2000 Sep;29(9):343. Gorse Lane
Clacton-on-Sea, Essex CO15 4XA
Healthcare Hazard Control England
Phone: 44 (1255) 428328
Ethylene oxide hazard evaluation and field survey.
Fax: 44 (1255) 222987
Chemical hazards:3.5.
E-mail: sales@anderseneurope.com
Ethylene oxide. 2:Chemical hazards:3. Internet: http://www.anpro.com

8 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

ARS Fedegari

ARS Enterprises [105285]

Fedegari Autoclavi SpA [309507]
12900 Lakeland Rd
via Degli Abeti 300
Santa Fe Springs CA 90670-4517
I-61100 Pesaro
Phone: (562) 946-3505, (800) 735-9277
Italy
Fax: (562) 946-4120
Phone: 39 (0721) 26243
E-mail: info@arsenterprises.com
Fax: 39 (0721) 26285
Internet: http://www.arsenterprises.com
E-mail: gdr@fedegari.com
Internet: http://www.fedegari.com
Baumer

Baumer S/A [179534]

Avenida Prefeito Antonio Tavares Leite Nr 181 Sakura
Parque da Empresa
13800-000 Mogi Mirim-SP Sakura Finetechnical Co Ltd [157040]
Brazil 1-9 Honcho 3-chome
Phone: 55 (19) 38065955 Nihonbashi Chuo-ku
Fax: 55 (19) 38063317 Tokyo 103
E-mail: baumer@baumer.com Japan
Internet: http://www.baumer.com Phone: 81 (3) 32701666
Fax: 81 (3) 32702779
E-mail: intl@sakura-finetek.jp
Buxton Internet: http://www.sakura-finetek.jp

Buxton Medical Service Corp [107013]

1178 Rt 109
Lindenhurst NY 11757-1004 STERIS
Phone: (631) 957-4500
Fax: (631) 957-3884 STERIS Corp [107114]
E-mail: pmccann@buxtonmed.com 5960 Heisley Rd
Internet: http://www.buxtonmed.com Mentor OH 44060-1834
Phone: (440) 354-2600, (800) 548-4873
Fax: (440) 639-4459
Demed Internet: http://www.steris.com
Medicor Mutotechnika Kft [347077]
Fueredi uitz 98 STERIS Corp (Hong Kong) [227264]
H-4032 Debrecen Room 301-2 3/Fl Kodak House II
Hungary 39 Healthy Street East
Phone: 36 (52) 415569 North Point
Fax: 36 (52) 410485 Hong Kong SAR
People’s Republic of China
Phone: 852 25633623
Fax: 852 25637387
DMB-STERIVIT-Automatic
Internet: http://www.steris.com
DMB-Apparatebau GmbH [157961]
Saarbruecker Allee 1 STERIS Ltd (Europe) [355810]
Postfach 130245 The Stable Block
D-65090 Wiesbaden Cornbury Park
Germany Charlbury, Oxfordshire OX7 3EH
Phone: 49 (611) 9284602 England
Fax: 49 (611) 9284651 Phone: 44 (1608) 811822
E-mail: info@dmb-apparatebau.de Fax: 44 (1608) 811854
Internet: http://www.dmb-apparatebau.de Internet: http://www.steris.com

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 9
Healthcare Product Comparison System

3M Health Care Recorder: Most sterilizers have a recorder that can

3M Asia Singapore Pte Ltd [267252] document the total cycle time, phases and elapsed
9 Tagore Ln time, all set points, the date, alarms, and a cycle
Singapore 787472 summary.
Republic of Singapore H × W × D, cm (in): Refers to exterior dimensions.
Phone: 65 64548611 Height for tabletop model is with the lid open.
Fax: 65 64568953
Price: Some of the pricing information in these charts
E-mail: innovation.sg@mmm.com
has been derived from list prices reported to ECRI’s
Internet: http:www.3m.com.sg
in-house information services by healthcare institu-
3M Health Care [104967] tions and by suppliers. A footnote identifies these
3M Center Bldg 275-4E-01 prices. In these instances, suppliers have declined to
St Paul MN 55144-1000 provide HPCS directly with prices and may not have
Phone: (800) 228-3957 confirmed the information. These prices are esti-
Fax: (651) 633-2072 mates and may or may not reflect discounts, options,
E-mail: healthcare@3m.com special packages, and multiple-unit sales. They are
Internet: http://www.3m.com/healthcare provided for the convenience of our readers.
3M Health Care Ltd [151078] Seismic anchoring/installation: Refers to Title 24 (Divi-
3M House sion T-17 of Part 6) of the California Administrative
Morley Street Code, which requires that support equipment on the
Loughborough, Leicestershire LE11 1EP sterilizer be constructed of sturdy materials and
England securely fastened to floors, ceilings, or other areas.
Phone: 44 (1509) 611611
Dual-loading system: In sterilizers that use a tank or
Fax: 44 (1509) 237288
cylinder to hold gas to be released during steriliza-
E-mail: innovation.uk@mmm.com
tion, a spare may be included as a backup. When the
Internet: http://www.3m.com/uk
first tank or cylinder is empty, a warning light
flashes, and the sterilizer automatically switches
Xinhua over to the second.
Shandong Xinhua Medical Instrument Factory
Abbreviations:
[291655]
No 2 Honggou Road ASME — American Society of Mechanical Engi-
Zhangdian neers
255027 Zibo
Shandong Province CE mark — Conformite Europeene mark
People’s Republic of China CLA — City of Los Angeles
Phone: 86 (533) 2183171
Fax: 86 (533) 2183211 CSA — Canadian Standards Association
E-mail: xhmed@public.zbptt.sd.cn
Internet: http://www.xhmed.com CUL — Canadian Underwriters Laboratories
The following terms are used in the chart: EPA — U.S. Environmental Protection Agency
Full cycle time, hr: The elapsed time from the start of FDA — U.S. Food and Drug Administration
the cycle (phase 1) to its completion (when the
end-of-cycle buzzer sounds), excluding aeration HCFC — Hydrochlorofluorocarbon
time. Times may be programmable, depending on
the sterilizer and the devices to be sterilized. kW — Kilowatts

EtO exposure, hr: The time (recommended by the
manufacturer) that devices are exposed to EtO.
Times may be programmable, depending on the
sterilizer and the devices to be sterilized.
In-chamber aeration: Times shown are those recom-
mended by the manufacturer. However, times may
be programmable, depending on the device to be
sterilized.
MDD — Medical Devices Directive
OSHA — U.S. Occupational Safety and Health
Administration
PC — Personal computer
psig — Pounds per square inch gauge
TUV — Technischer Ueberwachungs Verein

10 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

UL — Underwriters Laboratories features and characteristics are standard and which

Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
independent testing by ECRI or any other agency.
Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, prod-
ucts and specifications are subject to frequent changes.
ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
quences of acting on such information.
When reading the charts, keep in mind that, unless
otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which
are not, some may be optional, at additional cost.
For those models whose prices were supplied to us
in currencies other than U.S. dollars, we have also
listed the conversion to U.S. dollars to facilitate com-
parison among models. However, keep in mind that
exchange rates change often.
Need to know more?
For further information about the contents of this
Product Comparison, contact the HPCS Hotline at +1
(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
hpcs@ecri.org (e-mail).

About ECRI . . .
ECRI is a nonprofit health services research agency and a Collaborating Center of the World Health
Organization, providing information and technical assistance to the healthcare community to support
safe and cost-effective patient care for more than 25 years. The results of ECRI’s research and
experience are available through its publications, information systems, databases, technical assis-
tance program, laboratory services, seminars, and fellowships.

Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini-
stration, financial analysis, risk management, and information and computer science, as well as
hospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, and
registered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; and
writers, editors, and communications specialists.

Underlying ECRI’s knowledge base in healthcare technology are its integrity and objectivity. ECRI
accepts no financial support from medical product manufacturers, and no employee may own stock
in or consult for a medical equipment or pharmaceutical company.

The scope of ECRI’s resources extends far beyond technology. ECRI keeps healthcare professionals,
manufacturers, legal professionals, information specialists, and others aware of the changing trends
in healthcare, healthcare standards and regulations, and the best ways to handle environmental and
occupational health and safety issues. ECRI also advises on management issues related to healthcare
cost containment, accreditation, risk management, human resources, quality of care, and other
complex topics.

ECRI has more than 35 publications, databases, software, and services to fulfill the growing need
for healthcare information and decision support. They focus on three primary areas: healthcare
technology, healthcare risk and quality management, and healthcare environmental management.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 11
Healthcare Product Comparison System

Product Comparison Chart

MODEL ANDERSEN ARS ARS ARS

EOGas 306 : 310 : 84000 Series 84000 Series Beverly Pacific

333 Series 3 Floor Loading
WHERE MARKETED Worldwide Not specified Not specified Not specified

FDA CLEARANCE Submitted Yes Yes Yes

CE MARK (MDD) Yes No No No

CHAMBER
Size, m3 (ft3) 0.17 (6) : 0.28 (10) 0.11-0.85 1.1-1.98 1.1 (38.8) and up
: 0.92 (32.5) (3.9-30) (38.8-69.9)

Jacket material Stainless steel 316 stainless steel 316 stainless steel 316 stainless steel
or steel with
nickel-clad interior
TYPE OF GAS 100% EtO single-use 12/88 12/88 100% EtO or 12/88
cartridges
STANDARD CYCLE
Chamber pressure,
psig NA * 40 40 15-40
Warm temp, °C (F) 50 (122) 57 (134.6) 57 (134.6) 57 (134.6)
Cold temp, °C (F) 50 (122) 38 (100.4) 38 (100.4) 38 (100.4)
Full cycle time, hr 16, sterilization 3 warm, 8.5 cold 3 warm, 8.5 cold 3 warm, 8.5 cold
and aeration
EtO exposure, hr 16, sterilization 2.5 warm, 8 cold 2.5 warm, 8 cold 2.5 warm, 8.5 cold
and aeration
DOOR(S)
Configuration Single Single or double Single or double Single or double
Operation Manual, self-locking Manual Power Manual or power
(side sliding)

Hinge
1 door Front right side Left or right Left or right Customized

2 doors Back left side Left or right (both) Left or right (both) Customized

LOADING EQUIPMENT Wire rack shelves Car, transfer Floor cart Cart or pallets
carriage, trays

IN-CHAMBER AERATION Yes 8-12 hr 8-12 hr Yes

RECORDER Digital display, Dual pen Dual pen PC printer or

printer, load- circular chart
identification label
printer
AUDIBLE ALARMS Yes Yes Yes Yes
INSTALLATION
1-door sterilizer Cabinet-enclosed, Cabinet-enclosed, Recessed, floor or Recessed, floor or
recessed or pedestal recessed pit mounted pit mounted

2-door sterilizer Cabinet-enclosed, Cabinet-enclosed, Recessed, floor or Recessed, floor or

recessed, through recessed pit mounted pit mounted
partition wall
CO2 ADAPTABLE No Yes Yes Yes
HCFC ADAPTABLE No Yes Yes Yes
SINGLE-USE 100% EtO Yes No No No

Colons separate data on similar models of a device. This is the first of

* Negative-pressure system. two pages covering
the above model(s).
These specifications
continue onto the
next page.

12 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

Product Comparison Chart

MODEL ANDERSEN ARS ARS ARS

EOGas 306 : 310 : 84000 Series 84000 Series Beverly Pacific

333 Series 3 Floor Loading
UTILITY REQUIREMENTS
VAC, phase 110 or 220, 1-phase 120, 1-phase 120, 1-phase Customized

Power, kW 1 Not specified Not specified Not specified

Steam, avg psig NA 15 15 15

Water, avg psig NA 60-80, cold water 60-80, cold water 60-80, cold water
H x W x D, cm (in) 73.6 x 72.4 x 65.5 40.6 x 40.6 x 66 157.5 x 66 x 106.7 Customized
(29 x 28.5 x 25.8) : (16 x 16 x 26), (62 x 26 x 42),
99 x 62.2 x 65.5 50.8 x 50.8 x 96.5 157.5 x 66 x 193
(39 x 24.5 x 25.8) : (20 x 20 x 38), (62 x 26 x 76)
203.2 x 86.4 x 65.5 61 x 91.4 x [91.4,
(80 x 34 x 25.8) 121.9, 152.4] (24 x
36 x [36, 48, 60])

WEIGHT, kg (lb) 55.3 (122) : 79.4 431-567 1,360-3,175 Not specified

(175) : 215.5 (474) (948-1,247) (2,992-6,985)

PURCHASE INFORMATION
Price From $15,000 Not specified Not specified Not specified

Gas cost/cycle From $4 Not specified Not specified Not specified

Warranty 1 year, parts and 2 years, parts and 2 years, parts and 2 years, parts and
labor labor; 15 years, labor; 15 years, labor; 15 years,
vessel vessel vessel
Service contract Not specified Not specified Not specified Not specified
Delivery time, ARO 4 weeks 90-120 days 120-150 days 150-180 days

Year first sold 1996 Not specified Not specified Not specified

Number installed
USA Not specified Not specified Not specified Not specified
Worldwide Not specified Not specified Not specified Not specified

Fiscal year January to December November to October November to October November to October
OTHER SPECIFICATIONS Gas diffusion Liquid and gas Liquid and gas Custom cycles and
process matches dose separator tank separator tank control options;
size to load volume; (requires a vent (requires a vent zero-discharge
password entry; only); dual- only); dual- vacuum pump;
automatic load loading system; loading system; optional catalytic
tracking; zero-discharge zero-discharge converter with
diagnostic display; vacuum pump; vacuum pump; immediate system
custom chamber sizes optional catalytic optional catalytic connection;
on request; exhaust- converter with converter with backdraft safety
gas-abatement equip- immediate system immediate system assay.
ment available. connection. connection. Meets requirements
Meets requirements Meets requirements Meets requirements of ASME and CLA.
of CSA and OSHA; EPA of ASME and CLA. of ASME and CLA.
registered.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 13
Healthcare Product Comparison System

Product Comparison Chart

MODEL BAUMER BAUMER BUXTON DEMED
FAILED TO RESPOND *
EtO Advance EtO-Hivac Plus 9303 : 9304 : 9305 ** GST-21 : GST-21K :
GST-100
WHERE MARKETED Worldwide, except Worldwide, except Worldwide Europe
USA USA
FDA CLEARANCE No No No No
CE MARK (MDD) No No No Submitted

CHAMBER
Size, m3 (ft3) 0.10 (3.5) 0.25 (8.8), 0.36 0.51 (18) : 0.02 (0.7) : 0.02
(12.7), 0.5 (17.7), 0.68 (24) : (0.7) : 0.1 (3.5)
0.7 (24.7), 0.9 0.85 (30)
(31.8)
Jacket material 316 stainless steel 316 stainless steel Nickel-clad or Stainless steel
stainless steel

TYPE OF GAS 100% EtO 100% EtO, EtO/CO2, 10/90 EtO/HCFC cartridges,
EtO/HCFC EtO/CO2
STANDARD CYCLE
Chamber pressure,
psig -24 -10 to 45 4-10 29 : 26.1 : 65.3
Warm temp, °C (F) 59 (138.2) 54 (129.2) 54 (129.2) 54±8(129.2±14.4)
Cold temp, °C (F) 38 (100.4) 38 (100.4) Adjustable Not specified
Full cycle time, hr 8 8 2.5 to 6 5 : 5 : 16

EtO exposure, hr 4 4 Adjustable 4

DOOR(S)
Configuration Single Single or double Single or double Single
Operation Manual, self-locking Automatic, Manual or power Manual
self-locking

Hinge
1 door Vertical sliding Vertical sliding Customized Right

2 doors Vertical sliding Vertical sliding Customized Right

LOADING EQUIPMENT Manual Transfer cart Cart or carriage Manual, shelves

IN-CHAMBER AERATION Up to 16 hr Up to 16 hr Up to 99 hr No : No : Up to 11
hr
RECORDER Optional printer Printer Graphic and No : No :
alphanumeric Alphanumeric printer
recorder or chart

AUDIBLE ALARMS Yes Yes Yes No : No : Yes

INSTALLATION
1-door sterilizer Cabinet-enclosed or Cabinet-enclosed or Cabinet-enclosed, Cabinet-enclosed
recessed recessed recessed

2-door sterilizer Cabinet-enclosed or Cabinet-enclosed or Not specified Cabinet-enclosed

recessed recessed

CO2 ADAPTABLE No Yes Yes No : No : Yes

HCFC ADAPTABLE No Yes Yes Yes : Yes : No
SINGLE-USE 100% EtO Yes Yes No No : No : Yes

Colons separate data on similar models of a device. This is the first of

* Specifications current as of September 1999. two pages covering
** Buxton Medical also provides remanufactured Models 8303, 8304, and 8305. the above model(s).
These specifications
continue onto the
next page.

14 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

Product Comparison Chart

MODEL BAUMER BAUMER BUXTON DEMED
FAILED TO RESPOND *
EtO Advance EtO-Hivac Plus 9303 : 9304 : 9305 ** GST-21 : GST-21K :
GST-100
UTILITY REQUIREMENTS
VAC, phase 220/380, 3-phase 220/380, 3-phase 120 220-240, 1-phase

Power, kW 10 10 Not specified 400 : 400 : 3,500

Steam, avg psig NA 30-40 10-30 Not specified

Water, avg psig 10-30 10-30 40-60 Not specified

H x W x D, cm (in) 160 x 60 x 120 75 x 40 x 53 61 x 91.4 x 91.4 38 x 45 x 65
(63 x 23.6 x 47.2) (29.5 x 15.7 x 20.9) (24 x 36 x 36) : (15 x 17.7 x 25.6) :
or 180 x 80 x 120 61 x 91.4 x 121.9 38 x 45 x 108
(70.9 x 31.5 x 47.2) (24 x 36 x 48) : (15 x 17.7 x 42.5) :
61 x 91.4 x 152.4 157 x 110 x 58.5
(24 x 36 x 60) (61.2 x 43.3 x 23)

WEIGHT, kg (lb) 200 (441) 600 (1,320) Not specified 57 (125) : 63 (139)
: 270 (594)

PURCHASE INFORMATION
Price Not specified Not specified Not specified Not specified

Gas cost/cycle Not specified Not specified Not specified $5

Warranty 1 year, parts; 1 year, parts; 1 year, parts; 1 year, parts

10 years, chamber 10 years, chamber 90 days, labor

Service contract Not specified Not specified Not specified Not specified
Delivery time, ARO Not specified Not specified Not specified 6 weeks

Year first sold Not specified Not specified Not specified 1974 : 1977 : 1980

Number installed
USA NA NA Not specified NA
Worldwide Not specified Not specified Not specified 3,450 : 1,050 : 45

Fiscal year Not specified Not specified October to September January to December
OTHER SPECIFICATIONS None specified. Microprocessor Microprocessor- Pneumatic or elec-
controlled; optional controlled or tric door lock; door
continuous air wash, electromechanically lock block system;
emissions control, controlled systems parameter-controlled
and gas/water available. system.
separator. Meets requirements
of ASME.

Colons separate data on similar models of a device.

* Specifications current as of September 1999.
** Buxton Medical also provides remanufactured Models 8303, 8304, and 8305.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 15
Healthcare Product Comparison System

Product Comparison Chart

MODEL DEMED DMB-STERIVIT- FEDEGARI SAKURA
FAILED TO RESPOND * AUTOMATIC **
GST plusz-21 : plusz 30010-200010 : FOE AIIIE Series
-21K : plusz-100 Europak I-IV
WHERE MARKETED Europe Worldwide, except Worldwide Worldwide, except
North America Europe and USA
FDA CLEARANCE No No No No
CE MARK (MDD) Submitted Yes Yes No

CHAMBER
Size, m3 (ft3) 0.02 (0.7) : 0.02 0.1-10 (3.5-353.1) 0.45 (15.9) to 0.16 (5.6), 0.22
(0.7) : 0.1 (3.5) 30 (1,062.3) (7.8), 0.43 (15.2),
0.59 (20.8), 0.79
(27.9)
Jacket material Stainless steel Stainless steel AISI 304 Hot rolled steel

TYPE OF GAS EtO/HCFC cartridges, 6/94 EtO/CO2, EtO/CO2 20/80 EtO/CO2

EtO/CO2 15/85 EtO/CO2
STANDARD CYCLE
Chamber pressure,
psig 29 : 26.1 : 65.3 1.7-2.5 bar Up to 58 18.5 or 28.4
Warm temp, °C (F) 54±4 (129.2±7.2) 42-55 (107.6-131) 80 (176) 60 (140)
Cold temp, °C (F) Not specified Not specified 20 (68) Not specified
Full cycle time, hr 20 8 User selectable, Not specified
8-9 typical
EtO exposure, hr 2 2 User selectable, 3 to 99:59
3 typical
DOOR(S)
Configuration Single Single or double Single or double Single and double
Operation Manual Manual, automatic Self-locking, Manual swing,
automatic or double-locked by
semiautomatic steel arms/clutch
Hinge
1 door Right Left or right Sliding door Left or right

2 doors Right Left or right Sliding door Left or right

LOADING EQUIPMENT Manual, shelves Baskets, pallets Manual, shelves, Shelves, plates,
racks, baskets, loading car with
automatic pallets shelves

IN-CHAMBER AERATION Up to 16 hr >6 hr User selectable, Up to 99 hr, 59 min

unlimited
RECORDER Alphanumeric printer Printer Alphanumeric, Optional
printer/controller

AUDIBLE ALARMS Yes Yes Yes Yes

INSTALLATION
1-door sterilizer Cabinet-enclosed Floor mounted Cabinet-enclosed, Cabinet-enclosed or
floor or pit recessed
mounted
2-door sterilizer Cabinet-enclosed Floor mounted Cabinet-enclosed, Recessed mount
floor or pit
mounted
CO2 ADAPTABLE No : No : Yes No Yes Not specified
HCFC ADAPTABLE Yes : Yes : No No Yes Not specified
SINGLE-USE 100% EtO No : No : Yes No No No

Colons separate data on similar models of a device. This is the first of

* Specifications current as of September 1999. two pages covering
** Specifications current as of May 2001. the above model(s).
These specifications
continue onto the
next page.

16 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

Product Comparison Chart

MODEL DEMED DMB-STERIVIT- FEDEGARI SAKURA
FAILED TO RESPOND * AUTOMATIC **
GST plusz-21 : plusz 30010-200010 : FOE AIIIE Series
-21K : plusz-100 Europak I-IV
UTILITY REQUIREMENTS
VAC, phase 220-240, 1-phase 400 400, 3-phase; 1-phase for control,
others available 3-phase for pump
Power, kW 400 : 400 : 3,500 8.5-28 Depends on size of 0.2 for control,
autoclave 0.75 to 2.2 for pump
Steam, avg psig Not specified Not specified 20, minimum 43-57

Water, avg psig Not specified 3 bar, minimum 20, minimum 14-43
H x W x D, cm (in) 38 x 45 x 65 195 x 325 x 86 66 x 66 x 100 50 x 50 x [65, 90]
(15 x 17.7 x 25.6) : (76.8 x 128 x 33.9) (26 x 26 x 39.4) : (19.7 x 19.7 x
38 x 45 x 108 minimum 80 x 80 x 125 [25.6, 35.4]),
(15 x 17.7 x 42.5) : (31.5 x 31.5 x 49.2) 100 x 66 x [65, 90,
157 x 110 x 58.5 : 100 x 80 x 125 120] (39.4 x 26 x
(61.2 x 43.3 x 23) (39.4 x 31.5 x 49.2) [25.6, 35.4, 47.2])
: 130 x 90 x 150
(51.2 x 35.4 x 59.1)
: 115 x 106 x 200
(45.3 x 41.7 x 78.7) ***
WEIGHT, kg (lb) 57 (125) : 63 (139) 1,500 (3,307) Depends on size 600 (1,320), 660
: 270 (594) minimum (1,452), 830
(1,826), 1,030
(2,266), 1,230
(2,706)
PURCHASE INFORMATION
Price Not specified DM 300,000 From $110,000 Not specified
(US$134,374)

Gas cost/cycle $5 Depends on size Not specified Not specified

Warranty 1 year, parts 1 year 1 year 1 year, parts

Service contract Not specified Depends on volume Not specified Not specified
Delivery time, ARO 6 weeks 7 months 24 weeks Not specified

Year first sold 1997 : 1997 : 1998 1955 1978 Not specified

Number installed
USA NA NA None NA
Worldwide 2 : 5 : Not 1,150 20 Not specified
specified
Fiscal year January to December January to December January to December Not specified
OTHER SPECIFICATIONS Pneumatic or elec- None specified. None specified. Computer controlled;
tric door lock; door reserve timer;
lock block system; vacuum; results
parameter-controlled recorded up to 10
system; vacuum pump; times; leak-test
vacuum test. device; 3 steriliza-
tion programs.
Complies w/Japanese
Ministry of Labor's
Boiler Pressure-
Vessel Code and the
Japan Pharmaceutical
Affairs Law.

Colons separate data on similar models of a device.

* Specifications current as of September 1999.
** Specifications current as of May 2001.
*** Also available as 150 x 130 x 250 cm (59.1 x 51.2 x 98.4 in).

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 17
Healthcare Product Comparison System

Product Comparison Chart

MODEL STERIS STERIS 3M HEALTH CARE 3M HEALTH CARE

Eagle 3017 Eagle Series Steri-Vac 4XL : Steri-Vac 8XL

3048 : 3058 Steri-Vac 5XL
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) No No Yes Yes

CHAMBER
Size, m3 (ft3) 0.14 (4.9) 0.68 (24) : 0.11 (3.9) : 0.22 (7.8)
0.85 (30) 0.14 (4.9)

Jacket material Anodized aluminum Steel with nickel- Anodized aluminum Anodized aluminum
clad interior

TYPE OF GAS 100% EtO single-use HCFC blend 100% EtO single-use 100% EtO single-use
cartridges cartridges cartridges
STANDARD CYCLE
Chamber pressure,
psig NA * Up to 12 NA * NA *
Warm temp, °C (F) 54 (129.2) 54 (129.2) 55 (131) 55 (131)
Cold temp, °C (F) 38 (100.4) 38 (100.4) 37 (98.6) 37 (98.6)
Full cycle time, hr 2.5 warm, 6 cold 3 warm, 7.7 cold 2.5 warm, 5.5 cold : 3.75 warm, 5.5 cold **
2.75 warm, 4.75 cold **
EtO exposure, hr 1 warm, 4.5 cold 2.2 warm, 6.7 cold 1 warm, 4 cold 1 warm, 4 cold

DOOR(S)
Configuration Single or double Single or double Single *** Single, opt double
Operation Manual, self-locking Manual or power Manual, self-locking Manual, self-locking

Hinge
1 door Right side Left or right Front right side Front right side

2 doors Left side Left or right (both) NA : Back left side Back left side

LOADING EQUIPMENT 2 baskets, height- Shelves, racks, 2 baskets, optional 3 baskets, optional
adjustable loading cars, carriages, transfer cart transfer cart
car trays

IN-CHAMBER AERATION Up to 100 hr Up to 100 hr Up to 100 hr Up to 100 hr

RECORDER Printer controller Printer controller Graphic and Graphic and

alphanumeric alphanumeric
recorder recorder

AUDIBLE ALARMS Yes Yes Yes Yes

INSTALLATION
1-door sterilizer Cabinet-enclosed, Cabinet-enclosed, Cabinet-enclosed, Freestanding or
recessed, rack mount recessed recessed, rack mount † recessed

2-door sterilizer Double stacked Through 1 or 2 NA : Cabinet- Freestanding or

partition walls enclosed, recessed, recessed
pass-through
CO2 ADAPTABLE No No No No
HCFC ADAPTABLE No Yes No No
SINGLE-USE 100% EtO Yes No Yes Yes

Colons separate data on similar models of a device. This is the first of

* Negative-pressure system. two pages covering
** Without a hood, the cycle incorporates an additional 3 hr mandatory aeration time. the above model(s).
*** The Steri-Vac 5XL has an optional double-door configuration. These specifications
†
Can be placed on an elevated, stationary rack for ease of servicing and for loading and unloading. continue onto the
next page.

18 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

Product Comparison Chart

MODEL STERIS STERIS 3M HEALTH CARE 3M HEALTH CARE

Eagle 3017 Eagle Series Steri-Vac 4XL : Steri-Vac 8XL

3048 : 3058 Steri-Vac 5XL
UTILITY REQUIREMENTS
VAC, phase 100, 120, 240, 120, 1-phase; 200, 220, 1-phase 220, 1-phase
1-phase 230/460, 3-phase
Power, kW Not specified Not specified 1.4 1.6

Steam, avg psig NA 50-80 NA NA

Water, avg psig See footnote * 20-50, cold water See footnote * See footnote *
H x W x D, cm (in) 73.7 x 83.8 x 94 91.4 x 61 x 121.9 70 x 80 x 72 179 x 94 x 109
(29 x 33 x 37) (36 x 24 x 48) : (27.5 x 31.5 x 28.3) (70.5 x 37 x 42.9)
91.4 x 61 x 152.4 : 79 x 76 x 89
(36 x 24 x 60) (31.1 x 29.9 x 35)
with hood,
58.5 x 76 x 89
(23 x 29.9 x 35)
without hood

WEIGHT, kg (lb) 136.1 (299) Not specified 94 (207) : 127 (279) 340 (750)

PURCHASE INFORMATION
Price $32,500-34,500 $116,000-162,000 $29,975-31,995 $47,750

Gas cost/cycle $10 Not specified Not specified Not specified

Warranty 1 year, parts; 90 1 year, parts; 90 6 months, parts and 6 months, parts and
days, labor days, labor; 15 labor ** labor **
years, vessel agreement
Service contract Not specified Not specified Not specified Not specified
Delivery time, ARO Not specified Not specified Not specified Not specified

Year first sold 1994 Not specified 1981 : 1991 1995

Number installed
USA Not specified Not specified Not specified Not specified
Worldwide Not specified Not specified Not specified Not specified

Fiscal year January to December January to December Not specified Not specified
OTHER SPECIFICATIONS Built-in Envirogard Built-in Envirogard Localized vent Localized vent
exhaust hood; exhaust hood; system; error codes; system; error codes;
battery backup; battery backup; power interruption power interruption
supervisor access supervisor access restart; vacuum- restart; user codes;
code; aerate-pause code; aerate-pause operated cartridge vacuum-operated
capability; optional capability; optional puncture; all- cartridge puncture;
kit for seismic kit for seismic negative pressure all-negative
installations. installations. cycle; optional pressure cycle;
relative humidity optional relative
monitor; custom humidity control;
cycles upon request. custom cycles upon
Meets requirements request. Meets
of CSA, TUV, and UL. requirements of CE
and CUL.

Colons separate data on similar models of a device.

* An external water connection is not required. Unit has a self-contained reservoir for distilled water.
** Optional preventive maintenance agreement.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 19
Healthcare Product Comparison System

Product Comparison Chart

MODEL XINHUA

EOS360 : EOS600 :
EOS1000
WHERE MARKETED Not specified

FDA CLEARANCE Submitted

CE MARK (MDD) No

CHAMBER
Size, m3 (ft3) 0.36 (12.7) :
0.6 (21.2) :
1.0 (35.3)

Jacket material Anodized aluminum

TYPE OF GAS Not specified

STANDARD CYCLE
Chamber pressure,
psig 22
Warm temp, °C (F) 54 (129.2)
Cold temp, °C (F) 38 (100.4)
Full cycle time, hr 3.5 warm, 8 cold

EtO exposure, hr 2 warm, 6 cold

DOOR(S)
Configuration Single or double
Operation Manual or power

Hinge
1 door Customized

2 doors Customized

LOADING EQUIPMENT Shelves : Shelves :

Cart

IN-CHAMBER AERATION Up to 100 hr

RECORDER Dual pen, circular

chart

AUDIBLE ALARMS Visual

INSTALLATION
1-door sterilizer Floor

2-door sterilizer Floor

CO2 ADAPTABLE Yes

HCFC ADAPTABLE No
SINGLE-USE 100% EtO No

Colons separate data on similar models of a device. This is the first of

two pages covering
the above model(s).
These specifications
continue onto the
next page.

20 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Sterilizing Units, Ethylene Oxide

Product Comparison Chart

MODEL XINHUA

EOS360 : EOS600 :
EOS1000
UTILITY REQUIREMENTS
VAC, phase 220, 1-phase;
380, 3-phase
Power, kW 16 : 16.5 : 20

Steam, avg psig Not specified

Water, avg psig 21-43

H x W x D, cm (in) 150 x 90 x 167
(59.1 x 35.4 x 65.7)
: 210 x 112 x 190
(82.7 x 44 x 74.8) :
260 x 112 x 190 :
(102.4 x 44 x 74.8)
for 1-door models;
see footnote for
2-door models *

WEIGHT, kg (lb) 600 (1,323) :

1,200 (2,646) :
1,800 (3,969)

PURCHASE INFORMATION
Price Not specified

Gas cost/cycle Not specified

Warranty 1 year

Service contract Not specified

Delivery time, ARO Not specified

Year first sold 1992

Number installed
USA Not specified
Worldwide 80 : 100 : 120

Fiscal year Not specified

OTHER SPECIFICATIONS None specified.

Colons separate data on similar models of a device.

* 2-door models: 120 x 90 x 167 cm (47.2 x 35.4 x 65.7 in) : 170 x 112 x 190 cm (66.9 x 44 x 74.8 in) : 220 x 112 x 190 cm
(86.6 x 44 x 74.8 in).

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 21