(139 days)
Not Found
No
The document describes a standard steam sterilizer with a control system that monitors and sequences cycle phases. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
This device is a sterilizer for surgical instruments and linens, not a device used for treating or diagnosing patients.
No
Explanation: This device is a sterilizer, used for the sterilization of medical instruments and linens, not for diagnosing medical conditions.
No
The device description clearly states it is a "Steam Sterilizer" and describes physical components and processes involving pressurized steam, indicating it is a hardware device with a control system, not software only.
Based on the provided information, the Getinge GSS610N21 Series Steam Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical devices and materials (surgical instruments, linens) used in healthcare facilities. This is a process performed on devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a steam sterilization process, which is a method of disinfection/sterilization, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Getinge GSS610N21 Series Steam Sterilizer does not fit this definition.
N/A
Intended Use / Indications for Use
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters
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)
| Test Performed | Device Description | Test Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| Biological Performance Tests | ||||
| Sterilization Efficacy Validation Biological Performance with a fabric PCD | GSS610N21 | AAMI ST8:2013 (R2018) §5.5.2 | Sterility Assurance Level (SAL) 10-6 | Pass |
| Biological Performance with liquid loads | GSS610N21 | AAMI ST8:2013 (R2018) §5.5.3 | Sterility Assurance Level (SAL) 10-6 | Pass |
| Biological Performance with a wrapped instrument PCD | GSS610N21 | AAMI ST8:2013 (R2018) §5.5.4 | Sterility Assurance Level (SAL) 10-6 | Pass |
| Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items | GSS610N21 | AAMI ST8:2013 (R2018) §5.5.5 | Sterility Assurance Level (SAL) 106 | Pass |
| Physical Performance Test | ||||
| Chamber Temperature Profile | GSS610N21 | AAMI ST8:2013 (R2018) §5.4.2.5 | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
| Mechanical Air Removal Test | GSS610N21 | AAMI ST8:2013 (R2018) §5.6.1 | Load reaching exposure temperature within 10 secs Color change on BD chemical indicator sheet | Pass Pass |
| Air Leak Rate Test | GSS610N21 | AAMI ST8:2013 (R2018) §5.6.2 | Average leak rate of 1 mmHg (0.13 kPa) (0.019 psia) per minute or less over the measured time interval. | Pass |
| Moisture Retention Rest | GSS610N21 | AAMI ST8:2013 (R2018) §5.7 |
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2022
Maquet GmbH % Barb Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Wayne, New Jersey 07470
Re: K214120
Trade/Device Name: GSS610N21 Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 13, 2022 Received: April 14, 2022
Dear Barb Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Getinge GSS610N21 Steam Sterilizer
Indications for Use (Describe)
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Please see "GSS610N Load chart table" (1 page) as attachment to this form.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a sans-serif font, with a stylized asterisk symbol to the right. The asterisk is made up of four arrow-like shapes pointing outwards from a central point. The color of the logo is a dark blue.
| Cycle Type | Factory Settings | | | Load Configuration
(Note 1) | Maximum Items for
Model 61021
[2100 mm or 82.7 in
chamber length] |
|--------------------------|----------------------|------------------|--------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Exp.
Temp. | Exp.
Time | Drying
Time | | |
| P1 PREVAC 1 | 135.0°C
(275.0°F) | 3 min | 16 min | Full instrument packs | 36 |
| P2 PREVAC 2 | 135.0°C
(275.0°F) | 3 min | 3 min | Full fabric packs | 80 |
| P3 PREVAC 4 | 132.2°C
(270.0°F) | 4 min | 30 min | Full instrument packs | 36 |
| P4 PREVAC 5 | 132.2°C
(270.0°F) | 4 min | 5 min | Full fabric packs | 80 |
| P5 B & D TEST | 134°C
(273.0°F) | 3 min,
30 sec | 0 min | 1 B&D Test Pack in an EMPTY
chamber (other than loading
accessories) | 1 B&D Test Pack |
| P6 GRAVITY 1 | 121.1°C
(250.0°F) | 30 min | 45 min | Full instrument packs | 36 |
| | | | | Full fabric packs | 80 |
| P7 GRAVITY 2 | 135.0°C
(275.0°F) | 10 min | 45 min | Full instrument packs | 36 |
| | | | | Full fabric packs | 80 |
| P8 GRAVITY 3 | 132.2°C
(270.0°F) | 15 min | 45 min | Full instrument packs | 36 |
| | | | | Full fabric packs | 80 |
| P9 IUSS 1
Vac | 135.0°C
(275.0°F) | 3 min | 1 min | Full instrument packs | 1 |
| P10 IUSS 2
Grav | 135.0°C
(270.0°F) | 10 min | 30 sec | Full instrument packs | 1 |
| P11 IUSS 3
Grav | 132.2°C
(270.0°F) | 4 min | 1 min | Full instrument packs | 1 |
| P12
Vented
Bottles | 121.1°C
(250.0°F) | 45 min | 3kPa/min
(0.44 psi/
min)
(Note 2) | Each container 1000 mL (34 fl
oz) or smaller (Note 3) | 3 |
Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
- The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAM Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 and were made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAM Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
2. Cooldown rate
- Use vented or open containers only.
4
GETT
510(k) Summary Getinge GSS610N21 Series Steam Sterilizer K214120
| Submitted by | Maquet GmbH |
|---|---|
| Kehler Strasse 31 | |
| Rastatt DE-BW | |
| Germany 76437 |
- Contact person Barb Smith Sr. Regulatory Affairs Specialist Phone: 585-370-6101 Email: barb.smith@getinge.com
- K214120 510(k) number
- Date Prepared December 22, 2021
Proprietary Device Name
- Trade Name: Getinge GSS610N21 Series Steam Sterilizer
Models: 610N21 82.7 inch (2100 mm) long chamber Common Name: Steam Sterilizer Classification: Steam Sterilizer (21CFR880.6880, Product Code 80 FLE)
Predicate Devices
[K201927] Getinge GSS610N Series Steam Sterilizer Getinge Models 610N10, 610N14 and 610N15. SE Date 03/01/2021
5
Image /page/5/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is in a dark blue color.
Description of Device
The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters
Indications for Use
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Cycles and Load Chart
| Cycle Type | Factory Settings | | | Load Configuration
(Note 1) | Maximum
Items for
Model
61021
[2100 mm or
82.7 in
chamber
length] |
|---------------|----------------------|---------------------|-------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Exp.
Temp. | Exp.
Time | Drying Time | | |
| P1 PREVAC 1 | 135.0°C (275.0°F) | 3 min | 16 min | Full instrument packs | 36 |
| P2 PREVAC 2 | 135.0°C
(275.0°F) | 3 min | 3 min | Full fabric packs | 80 |
| P3 PREVAC 4 | 132.2°C (270.0°F) | 4 min | 30 min | Full instrument packs | 36 |
| P4 PREVAC 5 | 132.2°C (270.0°F) | 4 min | 5 min | Full fabric packs | 80 |
| P5 B & D TEST | 134°C (273.0°F) | 3 min,
30
sec | 0 min | 1 B&D Test Pack in an EMPTY
chamber (other than loading
accessories) | 1 B&D Test
Pack |
| P6 GRAVITY 1 | 121.1°C (250.0°F) | 30 min | 45 min | Full instrument packs
Full fabric packs | 36
80 |
| P7 GRAVITY 2 | 135.0°C (275.0°F) | 10 min | 45 min | Full instrument packs
Full fabric packs | 36
80 |
| P8 GRAVITY 3 | 132.2°C (270.0°F) | 15 min | 45 min | Full instrument packs
Full fabric packs | 36
80 |
Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart
6
| P9 IUSS 1
| Vac | 135.0°C (275.0°F) | 3 min | 1 min | Full instrument packs | 1 |
|---|---|---|---|---|---|
| P10 IUSS 2 | |||||
| Grav | 135.0°C (270.0°F) | 10 min | 30 sec | Full instrument packs | 1 |
| P11 IUSS 3 | |||||
| Grav | 132.2°C (270.0°F) | 4 min | 1 min | Full instrument packs | 1 |
| P12 | |||||
| Vented Bottles | 121.1°C (250.0°F) | 45 min | 3kPa/min | ||
| (0.44 psi/min) | |||||
| (Note 2) | Each container 1000 mL (34 fl oz) | ||||
| or smaller (Note 3) | 3 |
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAMI Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 andwere made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
-
- Cooldown rate
-
- Use vented or open containers only.
Technological Characteristics Table:
Shown below is a comparison of the subject device Getinge GSS610N21 Series Steam Sterilizer versus the predicate device (Getinge GSS610N Series Steam Sterilizer models 610N10, 610N14, 610N15). The GSS610N21 sterilizer is the largest model in the GSS610N series of steam sterilizers:
| Item | Getinge GSS610N
[Predicate device]
K201927 | Getinge GSS610N21
[Subject Device] | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Pressure Vessel | | | |
| Chamber Sizes | Model 610N10: 26.4" x
42.5" x 40.9" (672 x1080
x1040 mm) | Model 610N21: 26.4" x
42.5" x 82.7" (672 x 1080
x 2100 mm) | Different Chamber
Sizes |
| | Model 610N14: 26.4" x
42.5" x 55.1" (672 x1080
x1400 mm) | | Different Chamber
Sizes |
| Item | Getinge GSS610N
[Predicate device]
K201927 | Getinge GSS610N21
[Subject Device] | Comparison |
| | Model 610N15: 26.4" x
42.5" x 60.6" (672
x1080 x1540 mm) | | Different Chamber
Sizes |
| Chamber Volumes | Model 610N10: Single Door
26.52 Cu Ft (751L), Double
Door 26.59 Cu Ft (753L)
Model 610N14: Single Door
35.73 Cu Ft (1012L),
Double Door 35.77 Cu Ft
(1013L)
Model 610N15: Single Door
39.3 Cu Ft (1113L), Double
Door 39.34 Cu Ft (1114L) | Model 610N21: Double Door
53.67 Cu Ft
(1520L) | The chamber
volumes correspond
to the chamber sizes.
Only double door
configuration
available for
subject device. |
| ASME Pressure Vessel | All pressure vessels are
built to ASME Sect. VIII,
Div. 1 | All pressure vessels are built
to ASME Sect. VIII, Div. 1 | Same |
| "U" Stamped Unfired
Pressure Vessel) | Chamber: 45 psi
Jacket: 45 psi | Chamber: 45 psi
Jacket: 45 psi | Same |
| Material of Jacket | Stainless Steel (SA240-
304) | Stainless Steel (SA240- 304 ) | Same |
| Material of Chamber | Stainless Steel (SA240-
316L ) | Stainless Steel (SA240-316L ) | Same |
| Vacuum method | Vacuum pump standard. | Vacuum pump standard. | Same |
| Chamber Closure | | | |
| Door Operation | Horizontal opening/closing
door design operated by
an electrical motor. | Horizontal opening/closing
door design operated by an
electrical motor. | Same |
| Safety and Interlocks | | | |
| Door switch
system/steam to
chamber interlock | Electro-mechanical logic | Electro-mechanical logic | Same |
| Cycles | | | |
| Types of cycles offered | Prevac 132.2°C, 4
min; 135°C, 3 min,
Gravity 121°C, 30 min;
135°C 10 min; 132.2°
15 min; | Prevac 132.2°C, 4 min;
135°C, 3 min,
Gravity 121°C, 30 min;
135°C 10 min; 132.2° 15
min; | Same |
| Item | Getinge GSS610N
[Predicate device]
K201927 | Getinge GSS610N21
[Subject Device] | Comparison |
| | IUSS 135°C, 3 min,;
135C, 10 min; 132.2°C
4 min
Vented Bottles 121°C
45min.
BD Test | IUSS 135°C, 3 min,;
135C, 10 min; 132.2°C 4
min
Vented Bottles 121°C
45min.
BD Test | |
| Maximum Load
Capacities | Reference chart for
maximum loads within
GSS610N - up to 25lbs
per tray | Reference chart for
maximum loads within
GSS610N21 - up to 25lbs
per tray | Maximum load
increases with
larger chamber size |
| Utility Requirements
Primary
Electrical
Connection | GSS610N are available for
connection to:
208V 3ph 60Hz (Not
GSS61015N with integrated
electrical heated steam
boiler)
460V 3ph 60Hz
480V 3ph 60Hz | Available for connection to:
208V 3ph 60Hz (Not
GSS61021N with integrated
electrical heated steam
boiler) 460V 3ph 60Hz
480V 3ph 60Hz
600V 3ph 60Hz | Same
Limited for
Subject device due
to dual boilers |
7
Image /page/7/Picture/0 description: The image shows the logo for Getinge. The word "GETINGE" is written in a bold, sans-serif font in a dark blue color. To the right of the word is a stylized asterisk symbol, which is also in a dark blue color. The asterisk is made up of four curved arrows pointing inward.
8
Image /page/8/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is simple and modern.
Summary of Performance Testing
Shown below is a summary of the non-clinical testing that was performed with this device:
| Test
Performed | Device
Description | Test Method | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------|-----------------------|------------------------------------|-----------------------------------------|---------|
| Biological Performance Tests | | | | |
| Sterilization
Efficacy Validation
Biological
Performance with
a fabric PCD | GSS610N21 | AAMI ST8:2013
(R2018)
§5.5.2 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Biological
Performance with
liquid loads | GSS610N21 | AAMI ST8:2013
(R2018)
§5.5.3 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Biological
Performance with
a wrapped
instrument PCD | GSS610N21 | AAMI ST8:2013
(R2018)
§5.5.4 | Sterility Assurance
Level (SAL) 10-6 | Pass |
510k Summary GSS610N21_
9
Image /page/9/Picture/0 description: The image shows the logo for GETINGE. The text "GETINGE" is written in a bold, sans-serif font, with each letter in uppercase. To the right of the text is an abstract symbol that looks like four stylized arrows pointing towards the center. The logo has a blue color.
| Biological
performance of
immediate-use
steam sterilization
for single-wrapped
or unwrapped
nonporous items | GSS610N21 | AAMI ST8:2013
(R2018)
§5.5.5 | Sterility Assurance
Level (SAL) 106 | Pass |
|-------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------|
| Physical Performance Test | | | | |
| Chamber
Temperature
Profile | GSS610N21 | AAMI ST8:2013
(R2018)
§5.4.2.5 | +3°C (or +6°F) and -
0°C (or -0°F) of the
selected sterilization
exposure temperature | Pass |
| Mechanical Air
Removal Test | GSS610N21 | AAMI ST8:2013
(R2018)
§5.6.1 | Load reaching
exposure temperature
within 10 secs
Color change on BD
chemical indicator
sheet | Pass
Pass |
| Air Leak Rate Test | GSS610N21 | AAMI ST8:2013
(R2018)
§5.6.2 | Average leak rate of 1
mmHg (0.13 kPa) (0.019
psia) per minute or less
over the measured time
interval. | Pass |
| Moisture
Retention Rest | GSS610N21 | AAMI ST8:2013
(R2018)
§5.7 |