The Getinge 700HC-E 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. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.

Device Description

The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).

The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

AI/ML Overview

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are based on the ability to achieve sterilization of various loads under specified cycle parameters, and dryness of the load where applicable. The study proving the device meets these criteria involved comprehensive performance testing conforming to industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are implicitly defined by the successful demonstration of:

Achieving a sterility assurance level (SAL) of at least 10^-6.
Complete kill of biological indicators (BIs).
Moisture retention within specified limits for fabric and wrapped instrument packs.
Successful Bowie-Dick test for air removal.
Maintaining steady-state thermal conditions within the chamber.
Water loss not exceeding 50ml for liquid loads.

The reported device performance, demonstrated through validation testing against these criteria, confirmed that the sterilizer performs as intended.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Sterility Assurance	Sterility Assurance Level (SAL) of at least 10^-6	Achieved SAL of at least 10^-6 for all validated cycles.
Microbiological Efficacy	Complete kill of biological indicators (BIs)	Complete BI kill demonstrated across all validated cycles.
Temperature Profile	Steady-state thermal conditions consistent with predicated SAL in the load	Demonstrated by empty chamber testing.
Fabric Packs	Moisture retention < 3% increase in pre-sterilization test pack weight, no visible wet spots	Achieved for PREVAC and GRAVITY cycles using fabric packs.
Wrapped Instrument Packs	Moisture retention < 20% increase in pre-sterilization weight of towel, no visible wet spots on outer wrapper	Achieved for PREVAC (excluding PREVAC 2 & 5 with shortened drying times) and GRAVITY cycles using wrapped instrument packs.
Immediate Use (Flash) Cy	Complete BI kill. (Note: Drying not a primary criterion for these short cycles)	Complete BI kill demonstrated.
Liquid Loads	Water loss not exceeding 50ml	Achieved for liquid cycles.
Air Removal (Bowie-Dick)	Successful Bowie-Dick test	Performed successfully, demonstrating proper air removal.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical "sample size" in terms of number of sterilizer units tested or specific quantities of test cycles beyond stating "all cycles were validated." However, the testing was performed for each cycle type available on the Getinge 700HC-E Series Steam Sterilizer, for all three chamber sizes (39 inch, 53 inch, 61 inch), and for various load configurations as detailed in the "Cycles and Load Chart."

Test Sets: The "test set" consisted of various "process challenge devices" and load configurations specified by ANSI/AAMI ST8:2008, including:
- Fabric process challenge packs
- Wrapped instrument process challenge devices
- Unwrapped non-porous process challenge devices
- 3 one-liter flasks for liquid load cycles
- Bowie-Dick test packs
- Empty chambers for thermal mapping.
Data Provenance: The testing was performed according to "industry standards and guidelines," specifically referencing ANSI/AAMI ST8:2008, which is a standard applicable within the United States. The testing appears to be prospective as it validates the performance of the new device model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. Instead, the ground truth is established by objective, standardized methods and criteria defined by the ANSI/AAMI ST8:2008 standard and the expected biological and physical outcomes of sterilization. For example, "complete kill of biological indicators" is an objective, measurable outcome.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the performance testing is determined by objective measurements (e.g., direct observation of BI growth, temperature recordings, weight measurements) against pre-defined thresholds from the ANSI/AAMI ST8:2008 standard, rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (steam sterilizer), not an AI/imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a steam sterilizer, not an algorithm. However, the performance testing described is analogous to a "standalone" performance evaluation of the device itself, as it assesses the sterilizer's function without human intervention beyond operation and monitoring.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on:

Biological Indicators (BIs): Used to confirm the destruction of resistant microorganisms, providing a direct measure of microbial inactivation (sterility assurance).
Physical Measurements:
- Temperature and Time: Achievement of specific temperature and exposure time combinations (expressed as F0 value) within the chamber and load.
- Weight Measurement: To assess moisture retention in fabric and wrapped instrument packs.
- Volume Measurement: To assess water loss in liquid loads.
Chemical Indicators (Bowie-Dick Test): Used to detect air removal efficacy in dynamic-air-removal steam sterilizers.
Industry Standards: Adherence to the criteria and methodologies outlined in ANSI/AAMI ST8:2008 for "Hospital Steam Sterilizers."

8. The Sample Size for the Training Set

Not applicable. This device is a classic medical device (steam sterilizer) and does not involve machine learning or AI, and therefore does not have a "training set." The listed cycles and load configurations were extensively tested as part of the validation, representing the complete range of intended uses.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was used.

Summary

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K120441

510(k) SUMMARY

MAY 3 1 2012

Getinge 700HC-E Series Steam Sterilizer

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Barb Smith, RACSr. Manager, Regulatory AffairsPhone: (585) 214-6049Fax: (585) 272-5299
Date prepared:	February 6, 2012
Proprietary Name:	Model 700HC-E Series Steam Sterilizer
Common Name:	Steam Sterilizer
Device Classification:	Steam Sterilizer (80 FLE)Class II, as listed per 21 CFR 880.6880
Predicate Device:	Getinge Model 400HC/500HC Series Steam Sterilizer [K103504]

Description of Device:

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List of available cycles: Model 733HC-E Steam Sterilizer Cycles and Load Chart

Cycle Type	No. ofCycles	Factory Settings			Load Configuration(Note 1)	Maximum Items perChamber Length
		Exp.Temp.	Exp.Time	DryingTime		1.00 m(39 in.)	1.35 m(53 in.)	1.55 m(61 in.)
vacPREVAC	5	135.0°C(275.0°F)	3 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric Packs	24	32	48
vacPREVAC 2	3	135.0°C(275.0°F)	3 min	3 min(Note 4)	Fabric Packs	24	32	48
vacPREVAC 4	1	132.2°C(270.0°F)	4 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
vacPREVAC 5	1	132.2°C(270.0°F)	4 min	3 min(Note 4)	Fabric packs	24	32	48
vacB & D TEST	1	133.9°C(273.0°F)	3 min,30 sec	0 min	S.M.A.R.T. Pack orequivalent (1 max.) inan EMPTY chamber	1 TestPack	1 TestPack	1 TestPack
grvGRAVITY 1	4	121.1°C(250.0°F)	30 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
grvGRAVITY 2	3	135.0°C(275.0°F)	10 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
grvGRAVITY 3	1	132.2°C(270.0°F)	10 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
iusIMMEDUSE 1(Notes 1, 7)	1	135.0°C(275.0°F)	3 min	30 sec(Note 4)	Unwrapped,nonporousinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	3	3	3
liqLIQUIDS 1	1	121.1°C(250.0°F)	30 min	5.17kPa/min(0.75psi/min)(Note 3)	Each container1000 mL (34 fl oz) orsmaller(Notes 5, 6, 8)	112	154	196
liqLIQUIDS 2	1	121.1°C(250.0°F)	45 min	5.17kPa/min(0.75psi/min)(Note 3)	Each container1000 mL (34 fl oz) orsmaller(Notes 5, 6, 8)	112	154	196
lkLEAK TEST(Note 2)	1	131.1°C(268.0°F)	3 min.	15 mindry, 5minequalize15 mintest	Empty Chamber(other than loadingaccessories)	-	-	-

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Getinge Sourcing LLC FDA 510/k) Summary MAHALE Sprige Staam Starilize

NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.

TABLE NOTES:

1. 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 and were 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.
1. Vacuum leak test parameters are not adjustable.
1. Cooldown rate
1. Items may NOT be dry at the end of the following cycles:
- · IMMEDUSE 1
- · PREVAC2
- PREVAC5

Drying time may be added if required.

1. Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
1. Use vented or open containers only.
1. The recommended minimum exposure time and temperature for unwrapped, nonporous loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 135°C (275°F).
1. A small load of 1000mL (34 fl oz) containers requires an exposure time of 45 min.

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Intended Use:

The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

Comparisons to Predicate Device:

Similarities between the Getinge 700HC-E Series Steam Sterilizer and the identified predicate are:

Intended use is the same: 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.
Operating Principle is the same: Saturated steam is the sterilizing agent. ●
Materials of construction are the same: Vessel material is Stainless Steel . SA240-316Ti. There is no direct patient contact associated with this device.
Cvcle Types: The cvcle types offered are the same; Prevac (135°C, 132°C), . Gravity (121°C, 132°C, 135°C), Immediate Use (135°C) and Liquids 121°C (not for sterilization of liquids used directly for patient contact).
Performance Testing: Factory recommended cycles were tested per industry . standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.

The differences between the Getinge 700HC-E Series Steam Sterilizer and the predicate device (Getinge 400HC/500HC Series Steam Sterilizer) are:

The Getinge 700HC-E Series Steam Sterilizer has larger vessel sizes. . Because of the larger vessel size the chamber closure (door operation and door retaining method) are different. Also the larger chamber sizes require different piping and steam to chamber design to accommodate the increased chamber volume. The larger chamber size also allows for larger loads to be processed. Factory recommended maximum load sizes are tested for effectiveness and clearly identified in product labeling.
The Getinge 700HC-E Series Steam Sterilizer has an updated larger display. . The updated display provides four run screen formats as opposed to three and allows the user to interact with the controls by means of a touch screen.

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Summary of Performance Testing:

Factory recommended cycles were tested per industry standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.

The results of Getinge 700HC-E Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:

Empty chamber testing performed for all cycles as described in ANSI/AAMI . ST8:2008 Hospital Steam Sterilizers section 5.4.2.5. The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load.
All PREVAC and GRAVITY cycles were validated using fabric process . challenge packs as described in ANSI/AAMI ST8:2008 section 5.5.2. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots.
All PREVAC (excluding PREVAC 2 and PREVAC 5 that have shortened drying . times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8:2008 section 5.5.4. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete BI kill and moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper.
All Immediate Use (Flash) cycles were validated using a unwrapped non-. porous process challenge device as described in ANSI/AAMI ST8:2008 section 5.5.5. The results from this testing demonstrated a sterility assurance level of at least 10 6 through achievement of time at temperature sufficient to produce an Fo value of at least 12 and complete BI kill.
Liquid loads cycles were validated using 3 one liter flasks as described in . ANSI/AAMI ST8:2008 section 5.5.3. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and water loss not exceeding 50ml.
Bowie Dick cycle was validated using the Bowie-Dick test pack as described in . ANSI/AAMI ST8:2008 section 5.6.1.1.

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The software validation for the cycle operation was performed according to . FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)".

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 700HC-E Series Steam Sterilizer has the same intended use and technological characteristics as the predicate device. The 700HC-E Series Steam Sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards. Based on the information provided in this premarket notification, it can be concluded that the subject device is substantially equivalent to the predicate device and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Barb Smith Senior Manager Regulatory Affairs Getinge Sourcing, LLC 1777 East Henrietta Road Rochester, New York 14623-3133

MAY 3 1 2012

Re: K120441

Trade/Device Name: Getinge 700HC-E Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: II Product Code: FLE Dated: May1, 2012 Received: May 2, 2012

Dear Ms. 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. 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 Eederal Register.

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Page 2- Ms. Smith

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For G.P. Sheldrick M.D.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K120441

Device Name: Getinge 700HC-E Series Steam Sterilizer

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3 Page 1 of

Edi, litt F. Clamine-Well

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K12044 510(k) Number:

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List of available cycles:

Getinge 700HC-E Series Steam Sterilizer Model 733HC-E Cycles and Load Chart

Cycle Type	No. ofCycles	Factory Settings			Load Configuration(Note 1)	Maximum Items perChamber Length
		Exp.Temp.	Exp.Time	DryingTime		1.00 m(39 in.)	1.35 m(53 in.)	1.55 m(61 in.)
vacPREVAC	5	135.0°C(275.0°F)	3 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
				Fabric Packs	24	32	48
vacPREVAC 2	3	135.0°C(275.0°F)	3 min	3 min(Note 4)	Fabric Packs	24	32	48
vacPREVAC 4	1	132.2°C(270.0°F)	4 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
				Fabric packs	24	32	48
vacPREVAC 5	1	132.2°C(270.0°F)	4 min	3 min(Note 4)	Fabric packs	24	32	48
vacB & D TEST	1	133.9°C(273.0°F)	3 min,30 sec	0 min	S.M.A.R.T. Pack orequivalent (1 max.) inan EMPTY chamber	1 TestPack	1 TestPack	1 TestPack
grvGRAVITY 1	4	121.1°C(250.0°F)	30 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
grvGRAVITY 2	3	135.0°C(275.0°F)	10 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
grvGRAVITY 3	1	132.2°C(270.0°F)	10 min	45 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	10	15	20
					Fabric packs	24	32	48
iusIMMEDUSE 1(Notes 1, 7)	1	135.0°C(275.0°F)	3 min	30 sec(Note 4)	Unwrapped,nonporousinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	3	3	3
liqLIQUIDS 1	1	121.1°C(250.0°F)	30 min	5.17kPa/min(0.75psi/min)(Note 3)	Each container1000 mL (34 fl oz) orsmaller(Notes 5, 6, 8)	112	154	196
liqLIQUIDS 2	1	121.1°C(250.0°F)	45 min	5.17kPa/min(0.75psi/min)(Note 3)	Each container1000 mL (34 fl oz) orsmaller(Notes 5, 6, 8)	112	154	196
lkLEAK TEST(Note 2)	1	131.1°C(268.0°F)	3 min.	15 mindry, 5minequalize, 15 mintest	Empty Chamber(other than loadingaccessories)	-	-	-

. . . . .

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3.55 K120441

NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.

TABLE NOTES:

1. The load configurations listed in these tables are those used during testing validations of the sterilizer. The load configurations follow AAM Standard ST8: Hospital steam sterliizers where applicable (fabric packs are These conligerations form of in ANSI/AAMI ST8 and were made to be consistent with the packs process than one of the STS). 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.

Vacuum leak test parameters are not adjustable.
Cooldown rate
Items may NOT be dry at the end of the following cycles:

· IMMEDUSE 1
· PREVAC2
· PREVAC5

Drying time may be added if required.

Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
Use vented or open containers only.

1. The recommended minimum exposure time and temperature for unwrapped, loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 135°C (275°F).

A small load of 1000 mL (34 fl oz) containers requires an exposure time of 45 min.

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).