Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard steam sterilizer and does not mention any AI or ML capabilities.

Therapeutic

No
The device is a steam sterilizer designed to sterilize medical instruments and materials, not to treat patients.

Diagnostic

No
The device is a steam sterilizer, designed to sterilize medical instruments and materials, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly identifies the device as a "Steam Sterilizer," which is a physical piece of equipment used for sterilization. The summary also mentions "hardware components" in the context of verification and validation.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to sterilize medical items in healthcare facilities using high-pressure steam. This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose or monitor a condition.
Device Description: The description clearly states it's a "Steam Sterilizer" and its function is to sterilize and dry items.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents

The device is classified as a Class II Medical Device with Product Code FLE, which corresponds to a "Sterilizer, Steam, Hospital". This classification further confirms it's a sterilization device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-A012PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012. ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities. Sakura Sterilizer ASSR-A012. ASSR-A012W. ASSR-A012W. ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are available in the following configuration.

26.5" x 37.5" x 53" chamber size, Single or Double Door Prevacuum and Gravity

Product codes (comma separated list FDA assigned to the subject device)

FLE

Device Description

The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities.

The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120149

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).

Summary

0

JAN - 6 2014

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: K132439 -----------

1. Submitter's Identification: Sakura Seiki Co., Ltd. 46-1, Shinden Chikuma, Nagano 387-0018 Japan Phone: 81-26-273-3583 Fax: 81-26-273-2584
  Date Summary Prepared: January 3, 2014

2. Name of the Device:

Proprietary name: Sakura Steam Sterilizer ASSR-A012 Sakura Steam Sterilizer ASSR-A012W Sakura Steam Sterilizer ASSR-A012P Sakura Steam Sterilizer ASSR-A012PW Skytron Integrity 270 Steam Sterilizer Skytron Integrity 270 VP Steam Sterilizer

Common Name: Steam Sterilizer Regulation: 21CFR Part 880.6880, Class II Product Code: FLE

3. Common or Usual Name:

Common name: Steam Sterilizer Classification name: Sterilizer, Steam

4. Predicate Device Information:

Skytron Integrity 215 Steam Sterilizer, Skytron Integrity 215 SG Steam Sterilizer, K120149

5. Description:

The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-

1

AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities.

The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.

6. Intended Use:

Sakura Steam Sterilizer ASSR-A012. ASSR-A012W. ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012, ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities. Sakura Steam Sterilizer ASSR-A012, ASSR-A012W, ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are available in the following configuration.

26.5" x 37.5" x 53" chamber size, Single or Double Door Prevacuum and Gravity Sakura Steam Sterilizer ASSR-AO12 is a single door.

Sakura Steam Sterilizer ASSR-AO12W is a double door (pass through).

Sakura Steam Sterilizer ASSR-AO12P is a single door with vacuum pump. Sakura Steam Sterilizer ASSR-AO12PW is a double door (pass through) with vacuum pump.

Skytron Integrity 270 Steam Sterilizer is a single or double door (pass through). Skytron 270 VP Steam Sterilizer is a single or double door (pass through) with vacuum pump.

Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-AQ12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.

| Cycle | Validated Loads | Sterilize
Temp | Sterilize
Time | Dry Time |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|------------|
| Flash 1
(IU 1) | One unwrapped,
nonporous instrument no
heavier than 0.22 lbs. (100
gram) | 270 F (132 C) | 3 minutes | 1 minute |
| Flash 2
(IU 2) | Maximum of sixteen (16)
unwrapped instrument | 270 F (132 C) | 4 minutes | 1 minute |
| | | | | |
| | trays, maximum weight 25
pound (11.3 kg) each.
The maximum of three (3)
2 mm inside diameter
(minimum) and 400 mm
long (maximum) lumen
instruments per cycle load. | | | |
| Prevacuum
270 | Maximum of sixteen (16)
double-wrapped
instrument trays,
maximum weight 25
| 270 F (132 C) | 4 minutes | 30 minutes |
| Prevacuum
275 | Maximum of sixteen (16)
double-wrapped
instrument trays,
maximum weight 25
pound (11.3 kg) each.
The maximum of three (3)
2 mm inside diameter
(minimum) and 400 mm
long (maximum) lumen
instruments per cycle load. | 275 F (135 C) | 3 minutes | 30 minutes |
| Express
Prevacuum
(IU 3) | Maximum of sixteen (16)
single wrapped instrument
trays, maximum weight 25
pound (11.3 kg) each.
The maximum of three (3)
2 mm inside diameter
(minimum) and 400 mm
long (maximum) lumen
instruments per cycle load.
This cycle is intended for
immediate use and the
wrap used for this cycle is
not intended to be a sterile
barrier. | 270 F (132 C) | 4 minutes | 3 minutes |
| Gravity 1 | Maximum of thirty-two (32)
-fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes |
| Gravity 2 | Maximum of sixteen (16)
double-wrapped
instrument trays,
maximum weight 25
pound (11.3 kg) each. | 270 F (132 C) | 15 minutes | 30 minutes |
| Liquid | Three (3) 1,000 mill-liter
containers with vented | 250 F (121 C) | 45 minutes | 0 minutes |
| | closures. This cycle is
intended for non-patient
contacting devices only. | | | |
| Leak Test | Empty Chamber, test time
of 15 minutes. | N/A | N/A | N/A |
| Warm Up | Empty Chamber | 270 F (132C) | 4 minutes | 3 minutes |
| Bowie-Dick Test | Bowie-Dick Test Pack | 273 F (134 C) | 3.5 minutes | 2 minutes |

2

·

ﺘ

3

Note:

"IU" means "Immediate Use" cycle. 产

ン Liquid cycle is for non-patient contact use only.

7. Technological Characteristics

Comparison to Predicate Device

Sakura Steam Sterilizer Comparison to Legally Marketed Predicate

| Item Description | Sakura Steam
Sterilizer ASSR-
AO12, -AO12W, -
AO12P, -
AO12PW /
Skytron Integrity
270, 270 VP
Steam Sterilizer | Predicate
Product
(Sakura Steam
Sterilizer
ASSV-AB09,
09E
Skytron
Integrity 215,
215 SG Steam
Sterilizer,
K120149) | Substantially
Equivalent or
Different | | | | | | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication for Use | Sakura Steam
Sterilizer / Skytron
Integrity Steam
Sterilizer is
designed and
optimized for use
in health care
facilities. Sakura
Steam Sterilizer /
Skytron Integrity
Steam Sterilizer
incorporates high-
pressure steam to
sterilize non-
porous and
porous, heat and
moisture-stable
items and
materials used in | Sakura Steam
Sterilizer /
Skytron Integrity
Steam Sterilizer
is designed and
optimized for
use in health
care facilities.
Sakura Steam
Sterilizer /
Skytron Integrity
Steam Sterilizer
incorporates
high-pressure
steam to
sterilize non-
porous and
porous, heat
and moisture-stable | Same | | | | | | |
| | the health care
facilities. | stable items and
materials used
in the health care facilities. | | | | | | | |
| | Single Phase,
120VAC, 60Hz | Single Phase,
120VAC, 60Hz | Same | | | | | | |
| Electrical | 3 Phases,
208VAC, 60 Hz,
15 Amps.
Or, 3 Phase,
480VAC, 60 Hz, 7
Amps.
(For Vacuum
Pump option) | No Vacuum
Pump | Different | | | | | | |
| Frame | Carbon steel | Carbon steel | Same | | | | | | |
| Chamber | SUS 316L | SUS 316L | Same | | | | | | |
| Chamber Size &
Volume | 26.5 in x 37.5 in x
53 in | 21.5 in x 21.5 in
x 38 in | Substantially
Equivalent | | | | | | |
| | 32.3 ft3 | 11.1 ft3 | | | | | | | |
| System Weight -
Dry (no utilities,
no cabinet) | For Integrity 270:
Single Door -
1,516 kg / 3,335
lbs.
Double Door -
1,714 kg / 3,771
lbs. | For integrity
215: 760kg /
1675 lbs. For
Integrity 215
SG:
830 kg / 1830
lbs. | Substantially
Equivalent | | | | | | |
| | SUS SA-240 type
304L | SUS SA-240
type 304L | Same | | | | | | |
| Jacket | ASME section VIII,
Div. 1 | ASME section
VIII, Div. 1 | Same | | | | | | |
| Door | SUS 316L,
emergency
manual door
opening system | SUS 316L,
emergency
manual door
opening system | Same | | | | | | |
| Door | Single or double
door (pass
through) | Single Door | Substantially
Equivalent | | | | | | |
| Door Opening
Method | Manual Swing
type (open/close)
with power lock-up
by elevation of
door. | Automated
vertical sliding
door with foot
pedal | Substantially
Equivalent. | | | | | | |
| Door Seal | Steam activated
door seal | Steam activated
door seal | Same | | | | | | |
| Insulation | The entire exterior
surface of vessel | The entire
exterior surface | Same | | | | | | |
| | | | | | | | | | |
| | is insulated with
glass wool
insulation
materials.
Thickness: 25mm
Specific gravity:
24kg/m³ | of vessel is
insulated with
glass wool
insulation
materials.
Thickness:
25mm
Specific gravity:
24kg/m³ | | | | | | | |
| | Industrial grade
brass or SUS | Industrial grade
brass or SUS | Same | | | | | | |
| Control Valve | Actuated by
electric solenoid or
motor or manual
shutoff valves. | Actuated by
electric solenoid
or motor or
manual shutoff
valves. | Same | | | | | | |
| Piping | Stainless Steel
(SUS 304) or
flared copper | Stainless Steel
(SUS 304) or
flared copper | Same | | | | | | |
| Safety (pressure
relief) valves | ASME approved. | ASME
approved. | Same | | | | | | |
| Steam Source | House steam | House steam or
integrated
steam
generator. | Same | | | | | | |
| Steam Capacity
Requirement
(from house
steam) | 220 lbs./Hour | 100 lbs./Hour | Substantially
Equivalent. | | | | | | |
| Vacuum System | Water ejector as
standard
specification, and
the vacuum pump
option is available. | Water ejector as
standard
specification. | Substantially
Equivalent | | | | | | |
| Air Filtration | Cellulose-medium
type.
Main filter element
Material:
Polypropylene
Pre-filter element
Material: Cellulose
with phenol
impregnated.
Two filters are
used consisting of
one pre-filter and
the main filter:
Pre-filter: Fuji 6R- | Cellulose-
medium type.
Main filter
element
Material:
Polypropylene
Pre-filter
element
Material:
Cellulose with
phenol
impregnated.
Two filters are
used consisting
of one pre-filter | Same | | | | | | |
| | PALL (R1F070)
with the efficiency
of greater than
99.9999% for 0.3
micron particles.
(Refer to Exhibit
19 "Filter
Information - Pall
and Fuji "and
Exhibit 21 "Air
Filter
Replacement
Information") | filter:
Pre-filter: Fuji
6R-60
Main Filter:
PALL (R1F070)
with the
efficiency of
greater than
99.9999% for
0.3 micron
particles.
(Refer to Exhibit
19 "Filter
Information -
Pall and Fuji
"and Exhibit 21
"Air Filter
Replacement
Information") | | | | | | | |
| Control | Automatic
operation through
all phases of
sterilization cycle. | Automatic
operation
through all
phases of
sterilization
cycle. | Same | | | | | | |
| | Cycle parameters
can be selected
and programmed
by operator. | Cycle
parameters can
be selected and
programmed by
operator. | Same | | | | | | |
| | All cycle phases
are monitored
visually. | All cycle phases
are monitored
visually. | Same | | | | | | |
| | Cycle completion
indications are
monitored both
audibly and
visually. | Cycle
completion
indications are
monitored both
audibly and
visually. | Same | | | | | | |
| | Color liquid crystal
touch-panel
display. | Color liquid
crystal touch-
panel display. | Same | | | | | | |
| | Cycle progress
and information on
time, pressure and
temperature,
including any fault
statements, are
indicated on the
40-character | Cycle progress
and information
on time,
pressure and
temperature,
including any
fault statements,
are indicated on | Same | | | | | | |
| | impact printer. | the 40-character
impact printer. | | | | | | | |
| | Factory
programmed
operation cycles
are provided as
standardized
sterilizing cycles. | Factory
programmed
operation cycles
are provided as
standardized
sterilizing
cycles. | Same | | | | | | |
| Access (security)
Code | Requires entry of
a 4-digit access
code to operate
sterilizer and/or
change the cycle
values. | Requires entry
of a 4-digit
access code to
operate sterilizer
and/or change
the cycle values. | Same | | | | | | |
| | Temperature
readouts are both
in Fahrenheit or
Centigrade. | Temperature
readouts are
both in
Fahrenheit or
Centigrade. | Same | | | | | | |
| Temperature | Impact printer
provides recording
of time,
temperature,
pressure, cycle
number, sterilizer
number and date
for each cycle. | Impact printer
provides
recording of
time,
temperature,
pressure, cycle
number,
sterilizer number
and date for
each cycle. | Same | | | | | | |
| Printer Device | Included as
standard. Printed
on all pertinent
cycle data on 2
1/4 inch wide
paper. | Included as
standard.
Printed on all
pertinent cycle
data on 2 1/4
inch wide paper. | Same | | | | | | |
| Integrated Water
recirculation
system | Stainless Steel
reservoir with a
brass-recirculating
pump, provided as
standard. | Stainless Steel
reservoir with a
brass-
recirculating
pump, provided
as standard. | Same | | | | | | |
| Factory
Programmed
Cycle #s
(Including Liquid
cycle as Option) | 8 | 8 | Same | | | | | | |
| Factory-Programmed Sterilization Cycle - Prevacuum Configuration | | | | | | | | | |
| Flash 1
(IU 1) | 270 F. (132 C)
degree sterilize | 270 F. (132 C)
degree sterilize | Same | | | | | | |
| Flash 2
(IU 2) | temp., 3 min.
sterilize time, 1
min. dry time.
Unwrapped
nonporous, a
single instrument. | temp., 3 min.
sterilize time, 1
min. dry time.
Unwrapped
nonporous, a
single instrument. | Substantially
Equivalent | | | | | | |
| | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 1
min. dry time.
Maximum of
sixteen (16)
unwrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 1
min. dry time.
Maximum of six
(6) unwrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | | | | | | | |
| | Prevacuum 270 | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 30
min. dry time.
Maximum of
sixteen (16)
double wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 30
min. dry time.
Maximum of six
(6) double
wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | Substantially
Equivalent | | | | |
| | | Prevacuum 275 | | 275 F. (135 C)
degree sterilize
temp., 3 min.
sterilize time 30 | | 275 F. (135 C)
degree sterilize
temp., 3 min.
sterilize time 30 | Substantially
Equivalent | | |
| | | | | | | min. dry time.
Maximum of
sixteen (16)
double wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | | min. dry time.
Maximum of six
(6) double
wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | |
| | | | | Express
Prevacuum
(IU 3) | | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 3
min. dry time.
Maximum of
sixteen (16) single
wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | | 270 F. (132 C)
degree sterilize
temp., 4 min.
sterilize time, 3
min. dry time.
Maximum of six
(6) single
wrapped
instrument trays,
maximum weight
25 pound (11.3
kg) each. The
maximum of three
(3) 2 mm inside
diameter
(minimum) and
400 mm long
(maximum) lumen
instrument per
cycle load. | Substantially
Equivalent |
| | | Factory-Programmed Sterilization Cycle - Gravity Configuration | | | | | | | |
| | | Gravity 1 | | 250 F (121 C)
degree sterilize
temp. 30 min.
sterilize time, 15
min. dry time.
Maximum of thirty-
two (32) -fabric
packs. | | 250 F (121 C)
degree sterilize
temp. 30 min.
sterilize time, 15
min. dry time.
Maximum of
twelve (12) -fabric
packs. | Substantially
Equivalent | | |
| | Gravity 2 | 270 F (132 C)
degree sterilize
temp., 15 min.
sterilize time, 30 | | 270 F (132 C)
degree sterilize
temp., 15 min.
sterilize time, 30 | Substantially
Equivalent | | | | |
| | | min. dry time.
Maximum of
sixteen (16)
double wrapped
instruments,
maximum weight
25 pounds (11.3 | | min. dry time.
Maximum of six
(6) double
wrapped
instruments,
maximum weight
25 pounds (11.3 | | | | | |
| | Liquid Cycle
(Option) | kg) per tray.
250 F (121 C)
degree sterilize
temp., 45 min.
sterilize time.
Maximum of three
(3) 1,000 mill-liter
containers. | | kg) per tray.
250 F (121 C)
degree sterilize
temp., 45 min.
sterilize time.
Maximum of three
(3) 1,000 mill-liter
containers. | Same | | | | |
| SAL LEVEL
Based on
ANSI/AAMI
ST8: 2008
Section 5.5.2.5-a) |