The Amsco Century Medium Steam Sterilizer 26" x 26" is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and is available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Leak Test and DART (Bowie-Dick) cycles.

Device Description

The Amsco Century Medium Steam Sterilizer 26" x 26" is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Medium Steam Sterilizer 26" x 26" is substantially equivalent with the predicate device Amsco Century Medium Steam Sterilizer, K010865, cleared May 31, 2001.

The Amsco Century Medium Steam Sterilizer 26" x 26" is offered in the following configurations:

26" x 26" x 39" (660 mm x 660 mm x 991 mm)
26" x 26" x 49" (660 mm x 660 mm x 1245 mm)
26" x 26" x 61" (660 mm x 660 mm x 1520 mm)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Amsco Century Medium Steam Sterilizer 26" x 26":

This document describes the validation of a medical device (a steam sterilizer), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies (like expert involvement, MRMC studies, or training/test set details) are not applicable in the context of this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by ANSI/AAMI ST8-1994)	Reported Device Performance (Amsco Century Medium Steam Sterilizer)
All Cycles (SFPP, Wrap/SFPP, Gravity, Prevac, Liquid):	All Cycles: Demonstrated a sterility assurance level (SAL) of at least 10⁻⁶ (or 10⁻⁴ for some cycles, 10th for LIQUID, specific values are inconsistently described in the text, but the general requirement is 10⁻⁶). This was achieved through:
For Fabric Test Packs (SFPP, Gravity, Prevac cycles):
* Sterility Assurance Level (SAL) of at least 10⁻⁶ probability of survival	* Achieved an F₀ value of at least 12 (indicating sufficient time-at-temperature for sterilization and achieving a SAL of at least 10⁻⁶ or 10⁻⁴ depending on the cycle as inconsistently indicated).
* Moisture retention of less than 3% increase in pre-sterilization test pack weight	* Moisture retention of less than 3% increase in pre-sterilization test pack weight (for SFPP, Gravity, Prevac).
* No evidence of wet spots	* No evidence of wet spots (for SFPP, Gravity, Prevac).
For Full Load Instrument Trays (Wrap/SFPP, Prevac cycles):
* Sterility Assurance Level (SAL) of at least 10⁻⁶ probability of survival	* Achieved a SAL of at least 10⁻⁶ using half-cycle analysis.
* Moisture retention of less than 20% increase in pre-sterilization weight of the towel	* Moisture retention of less than 20% increase in pre-sterilization weight of the towel.
* No evidence of wet spots on the outer wrapper	* No evidence of wet spots on the outer wrapper.
For Liquid Cycles (250°F (121°C), 45 minutes, 3 x 1000 mL flasks):
* Sterility Assurance Level (SAL) of at least 10⁻⁶ (implied by "appropriate safety factor" and F₀ value)	* Achieved a SAL of at least "10th" (presumably 10⁻⁶ or 10⁻⁴, but the text literally says "10th" which is an error) through achievement of an F₀ value of at least 12.
* Water loss not exceeding 50 mL	* Water loss not exceeding 50 mL.
* Automatic sealing of the flask closure	* Automatic sealing of the flask closure.
For DART cycle (Bowie-Dick Test Pack):
* Uniform color change throughout the test sheet, as described in ANSI/AAMI ST8 Section 5.6.1.	* Demonstrated a uniform color change throughout the test sheet.
Software Validation:
* Meet FDA's moderate level of concern recommendations for software in medical devices (Guidance 5/29/98).	* Software validation for cycle operation was performed according to FDA's moderate level of concern recommendations.
Safety and Performance Requirements:
* UL Electromedical Code 3101	* Complies with UL Electromedical Code 3101 (certified by ITS).
* CSA Standard C22.2 No. 1010-1	* Complies with CSA Standard C22.2 No. 1010-1 (certified by ITS).
* ASME, Section VIII, Division 1 for unfired pressure vessels	* Complies with ASME, Section VIII, Division 1 for unfired pressure vessels.
Overall Effectiveness:
* Complete kill of biological indicators	* Effectiveness of sterilizer function and exposure time recommendations is demonstrated by complete kill of biological indicators.
* Verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10⁻⁶ probability of survival	* Demonstrated a sterility assurance level of at least 10⁻⁶ (or as specified for individual cycles, e.g., 10th for liquid, and 10⁻⁴ for some fabric pack cycles; there appears to be inconsistency in the reported SAL values, but the guiding principle is achieving a high SAL).

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

Sample Size: The document does not specify a numerical sample size in terms of the number of unique sterilization cycles performed for each test condition. Instead, it refers to the "verification studies" and indicates that "All [Cycle Type] cycles verified using..." were "qualified according to Section X.X.X ANSI/AAMI-ST8". The ANSI/AAMI ST8 standard would dictate the number of runs required for validation (e.g., typically 3 successful consecutive runs for each defined load and cycle).
Data Provenance: The studies were "verification studies" conducted by STERIS as part of their product development and regulatory submission. This implies they are prospective studies performed in a controlled, laboratory-like setting using the actual device. The country of origin is not explicitly stated for the data, but given the company's US location and submission to FDA, it is highly likely the testing was conducted in the United States or under US quality standards.

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

This information is not applicable in the context of a sterilizer validation study. The "ground truth" (i.e., whether sterilization was successful) is established through objective, scientific methods specified in the ANSI/AAMI ST8 standard, primarily:
- Biological Indicators (BIs): These contain resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are cultured after the cycle. If there's no growth, it indicates a successful kill.
- Physical Parameters: Monitoring temperature, pressure, and time, and calculating F₀ values.
- Chemical Indicators/Dye Tests: Like the Bowie-Dick test, which shows uniform color change for successful air removal.
- Gravimetric Analysis: Measuring moisture retention.
Therefore, "experts" in the sense of radiologists reviewing images for ground truth are not involved. Instead, the "ground truth" is determined by the objective results of these standardized tests.

4. Adjudication Method for the Test Set

Not Applicable. Since objective, quantifiable parameters and biological indicators, as per scientific standards (ANSI/AAMI ST8), determine success or failure, there is no need for an adjudication method by human observers for conflicting interpretations. The tests yield clear pass/fail results.

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 physical device (sterilizer), not an AI/ML system that assists human readers with diagnostic or interpretive tasks. Therefore, no MRMC study was performed, and there is no "human reader improvement with AI."

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

Not Applicable. This is a physical device performing a physical process. The "algorithm" refers to the sterilizer's internal control software and the factory-programmed cycles, which operate autonomously to achieve sterilization. The performance of the sterilizer itself (as a "standalone" system) is what these validation studies demonstrate. There is no human intervention during the sterilization process itself, only in loading/unloading and selecting the appropriate cycle.

7. The Type of Ground Truth Used

The ground truth used is primarily biological (complete kill of biological indicators) and physical/chemical (achievement of specified F₀ values, temperature/time profiles, moisture retention, water loss, uniform color change in Bowie-Dick tests, automatic flask seal), as defined by the ANSI/AAMI ST8 standard.
The overall "ground truth" reflects the sterility assurance level (SAL), which is a statistically defined probability of a non-sterile item, directly measured or inferred from the efficacy of spore inactivation.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is designed, engineered, and then validated against a set of predetermined performance standards.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The performance parameters and criteria for the sterilizer were established by industry standards (ANSI/AAMI ST8) and scientific principles of sterilization.

Summary

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K020747

510(k) SUMMARY

Submitter Information

Lori Haller, Manager, Regulatory Affairs STERIS Corporation 2424 West 23rd Street Erie, Pennsylvania 16506 (814) 870-8559 Date Summary Prepared: May 8, 2002

Introduction

The Amsco Century Medium Steam Sterilizer 26" x 26" is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Medium Steam Sterilizer 26' x 26" is substantially equivalent with the predicate device Amsco Century Medium Steam Sterilizer, K010865, cleared May 31, 2001.

The Amsco Century Medium Prevacuum Steam Sterilizer 26" x 26" is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-A):

CYCLES	STERILIZETEMPERATURE	STERILIZETIME	DRYTIME	RECOMMENDED LOAD
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack.
Prevac	270°F (132°C)	4 minutes	20 minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg) each.Fabric Packs. Refer to Table 2 for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 2 for recommended quantities.
Liquid	250°F (121°C)	45 minutes	N/A	Refer to Table 3 for recommended quantities.

Tablo 1-4

The Amsco Century Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-B):

Table 1-B

CYCLES	STERILIZETEMPERATURE	STERILIZETIME	DRYTIME	RECOMMENDED LOADS
SFPP	270°F (132°C)	4 minutes	20minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Wrap/SFPP	270°F (132°C)	4 minutes	20minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg)each. Non-Porous Goods only. Referto Table 2 for recommendedquantities.

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Prevac	270°F (132°C)	4 minutes	20minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg)each. Fabric Packs. Refer to Table 2for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.

The following table lists STERIS's recommended loads by sterilizer size:

Table 2	· I A L M H M H H
STARI	WRAPPED INSTRUMENT TRAYS	મ છે. વિદ્યાર તા
16" x 26" "
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26" x 26" -	Complete Collection Colline and Child Child Annual Child A for contrasted on Microsoft of Since And Property Property of Property of

The following table is a guideline for the liquid cycle processing:

Table 3

NUMBER OF CONTAINERS	VOLUME OF LIQUID INONE CONTAINER	MINIMUM RECOMMENDEDSTERILIZE TIME AT 250°F(121°C)
3	1000 mL	45 minutes

Effectiveness

Effectiveness of sterilizer function and exposure time recommendations is demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° probability of survival. STERIS validates its sterilization cveles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). Prior to release, the Amsco Century Medium Steam Sterilizer 26" x 26" will be validated to meet the requirements of ANSI/AAMI ST8, Third Edition, January, 1994.

The results of the Amseo Century Medium Steam Sterilizer 26" x 26" verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:

All SFPP cycles verified using the fabric test pack, described in Section 5.5.1.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSU/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All WRAP/SFPP cycles verified using full load instrument trays, described in 5.5.3.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.3 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.

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All GRAVITY cycles verified using the fabric test pack, described in Section 5.5.1.1 of t ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, a moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All PREVAC cycles verified using the fabric test pack, described in Section 5.5.1.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.1 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 104 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
All PREVAC cycles verified using full load instrument trays, described in 5.5.3.1 of . ANSI/AAMI-ST8, were qualified according to Section 5.5.3 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 using balf-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All LIQUID cycles verified using three 1,000 ml flasks, described in Section 5.5.2.1 of the t ANSI/AAMI-ST8, were qualified according to Section 5.5.2 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
The DART cycle verified using the Bowie-Dick Test Pack, as described in 5.6.1.1 of the . ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet.
The software validation for the cycle operation was performed according to FDA's moderate � level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98). "

Safety

STERIS sterilizers including the Amsco Century Medium Steam Sterilizer 26" x 26" have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Arnsco Century Medium Steam Sterilizer 26" x 26" complies with the following requirements:

Underwriters Laboratory (UL) Electromedical Code 3101 as certified by Intertek Testing . Services (ITS).
Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by . Intertek Testing Services.
. American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels.

Hazards - Failure of Performance

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

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To avoid failure, the user must ensure that the materials, instruments and devices to be sterilized are thoroughly cleaned, the manufacturer's instructions for use are followed, the cycle to be used for each type of sterilizer load has been validated, the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incidence of sterilizer malfunction or sterilization process failure is relatively rare. Further, there are no known reports in the literature of patient infections that have resulted from steam sterilizer failures. The technology designed into STERIS steam sterilizers including the Amsco Century Medium Steam Sterilizer 26" x 26" provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

User Information

STERIS conducts in-house training and has developed a series of user training videos that provide helpful information about the appropriate use of steam sterilizers. STERIS further provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed Operator Manual and other labeling. STERIS also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image within the circle appears to be a stylized representation of a human figure or a symbol related to health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2003

Ms. Lori Haller Manager, Regulatory Affairs Steris Corporation 2424 West 23rd Street Erie, Pennsylvania 16506

Re: K020747

Trade/Device Name: Amsco Century Medium Sterilizer 26 Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: March 5, 2002 Received: March 7, 2002

Dear Ms. Haller:

This letter corrects our substantially equivalent letter of May 17, 2002 regarding the product code.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Haller

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runres

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT DEVICE NAME: AMSCO CENTURY MEDIUM STEAM STERILIZER 26" X 26"

INDICATIONS FOR USE:

The Amsco Century Medium Steam Sterilizer 26" x 26" is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and is available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-. Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, WRAP/SFPP, Prevacuum, . Gravity, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Century Medium Prevacum Sterilizer 26" x 26" is equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 1-A):

CYCLES	STERILIZETEMPERATURE	STERILIZETIME	DRYTIME	RECOMMENDED LOAD
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack.
Prevac	270°F (132°C)	4 minutes	20 minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg)each. Fabric Packs. Refer to Table 2for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Liquid	250°F (121°C)	45 minutes	N/A	Refer to Table 3 for recommendedquantities.

Table 1-A

The Amsco Century Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-B):

Table 1-BCYCLES	STERILIZETEMPERATURE	STERILIZETIME	DRYTIME	RECOMMENDED LOADS
SFPP	270°F (132°C)	4 minutes	20minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Wrap/SFPP	270°F (132°C)	4 minutes	20minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg)each. Non-Porous Goods only.Refer to Table 2 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	20minutes	Double-wrapped Instrument Trays,maximum weight of 17 lbs (7.7 kg)each. Fabric Packs. Refer to Table2 for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.

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The following table lists STERIS recommended loads by sterilizer size:

Table 2

STERILIZER SIZE	WRAPPED INSTRUMENT TRAYS	FABRIC PACKS
26" x 26" x 39"
26" x 26" x 49"
womany and survey and served and service and many and mores.26" x 26" x 61"	11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

The following table is the guideline for liquid cycle processing:

Table 3

NUMBER OF CONTAINERS	VOLUME OF LIQUID INONE CONTAINER	MINIMUM RECOMMENDEDSTERILIZE TIME AT 250°F(121°C)
3	1000 mL	45 minutes

The Amsoo Century Medium Steam Sterilizer 26" x 26" is offered in the following configurations:

26" x 26" x 39" (660 mm x 660 mm x 991 mm) .
26" x 26" x 49" (660 mm x 660 mm x 1245 mm) .
26" x 26" x 61" (660 mm x 660 mm x 1520 mm) .

(Please Do Not Write Below This Line - Continue on Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

John Lovell

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K020747

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).