Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard steam sterilizer with various pre-programmed cycles and performance testing based on established standards. There is no mention of AI, ML, image processing, or any data-driven learning components.

Therapeutic

No.
The device is a steam sterilizer designed for sterilizing materials used in healthcare facilities, not for treating patients.

Diagnostic

No

This device is a steam sterilizer, designed to sterilize medical materials and instruments. Its function is to assure sterility rather than to diagnose medical conditions or interpret biological data.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical steam sterilizer with different models and door configurations, not a software-only device. While it mentions software validation for cycle operation, the core device is hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the sterilization of materials used in healthcare facilities. This is a process applied to medical devices and materials, not a test performed on biological samples to diagnose a condition.
Device Description: The device is a steam sterilizer, which is a piece of equipment used for sterilization, not for performing in vitro diagnostic tests.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Performance Studies: The performance studies focus on the effectiveness of the sterilization process (sterility assurance level, moisture retention), not on the accuracy or reliability of a diagnostic test.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

Product codes

FLE

Device Description

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.

The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:

Cycle	Pre-treatment	Sterilizing temperature	Sterilizing Time 1)	Drying time 2)	Recommended load 3)
PreVac 270 4S/30D	5 pulses	270 °F	4 min	30 min	Double wrapped instrument trays, max. weight of 25 lbs per tray, Fabric packs
PreVac 270 4S/5D	5 pulses	270 °F	4 min	5 min	Fabric packs 4)
PreVac 275 3S/30D	5 pulses	275 °F	3 min	30 min	Double wrapped instrument trays, max. weight of 25 lbs per tray, Fabric packs
Bowie-Dick Test	5 pulses	273 °F	3.5 min	1 min	One Bowie-Dick-Test-Pack
Gravity 270 15S/30D	Purge	270 °F	15 min	30 min	Double wrapped instrument trays, with non-porous instruments, max. weight of 25 lbs per tray
Liquid 250 45S	Purge	250 °F	45 min	0 min	Liquids, up to 1000 ml in vented or open containers 5)
Air leak Test	Vacuum: 65mbar Test time: 15 min	-	-	-	Empty chamber
Warm up & Air Leak Test	Vacuum: 65mbar Test time: 15 min	270 °F	3 min	3 min	Empty chamber
Warm up	2 pulses	270 °F	3 min	3 min	Empty chamber

Notes for Table 1:

Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.

The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:

Model	Instrument trays, max. 25 Ibs each	Fabric Packs, max. 3.3 lbs each
9-6-12	16	32
9-6-15	20	40
9-6-18	24	48

Table 2: Recommended loads for non-porous and porous load cycles

Model	Volume of liquid in one container	Number of containers
9-6-12	1000 ml	168
9-6-15	1000 ml	210
9-6-18	1000 ml	252

Table 3: Recommended loads for liquid cycle 250 °F

The Belimed Steam Sterilizer MST-H is offered in the following models:

Model	Configuration	Net loading capacity (L)	Chamber size (H x W x D) (mm)	Overall Dimensions (H x W x D) (mm)
9-6-12 HS1	1 door	691	1080 x 660 x 1398	1970 x 1700 x 1714
9-6-12 HS2	2 doors	691	1080 x 660 x 1398	1970 x 1700 x 1714
9-6-15 HS1	1 door	864	1080 x 660 x 1706	1970 x 1700 x 2022
9-6-15 HS2	2 doors	864	1080 x 660 x 1706	1970 x 1700 x 2022
9-6-18 HS1	1 door	977	1080 x 660 x 2014	1970 x 1700 x 2330
9-6-18 HS2	2 doors	977	1080 x 660 x 2014	1970 x 1700 x 2330

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

healthcare 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)

Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of 10-6 reduction. Belimed Sauter AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Steam Sterilizer MST-H, models 9-6-12, 9-6-15, and 9-6-18 were validated to meet the requirements of ANSI/AAMI ST8:2013.

The results of the Belimed Steam Sterilizer MST-H, models 9-6-12, 9-6-15, and 9-6-18 verification studies demonstrate that the sterilizers perform as intended and are summarized as follows:

Empty chamber testing was performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2013, for the PreVac, Gravity and Liquid cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that are corresponding with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the temperature control requirements of Section 4.4.2.5 of ANSI/AAMI ST8.
All PreVac 270 cycles were verified using a single fabric test pack for biological performance, as described in Section 5.5.2 ANSI/AAMI ST8:2013 were qualified according to section 5.5.2.5 of ANSI/AAMI ST8:2013. These cycles demonstrated a sterility assurance level (SAL) of 10-6 through achievement of no growth at half cycle with validation loads. Moisture retention of less than 3 % increase in pre-sterilization test pack weight was demonstrated with a single fabric pack and with full load fabrics, and no wet spots were examined, according to section 5.7.1.4 of ANSI/AAMI ST8:2013.
All PreVac and Gravity instrument cycles were qualified according to section 5.5.4 of ANSI/AAMI ST8:2013. The tests were performed with full load instruments trays, 25lbs each. Instead of cotton wrappers, FDA cleared wrappers (double wrapped) were used. These cycles demonstrated a sterility assurance level of 10-6 through achievement of no growth at half cycle with validation loads, moisture retention of less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper according to section 5.7.2.4 of ANSI/AAMI ST8:2013.
The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6.1 of ANSI/AAMI ST8:2013 and demonstrated a uniform color change throughout the test sheet (FDA cleared test indicator) and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
The liquid cycle was verified according to section 5.5.3 of ANSI/AAMI ST8:2013. This cycle demonstrated a sterility assurance level of 10-6 through achievement of no growth with validation loads and the temperature was above 121°C for at least 12 minutes. The loss of liquid did not exceed 70ml in a 1000ml bottle (unloading temperature 90°C). Additional tests with full load liquids showed the same results.
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 (May 2005)".

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

Sterility Assurance Level (SAL) of 10-6 reduction.
Moisture retention:

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

Image /page/0/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 features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

June 17, 2015

Belimed Sauter AG Michael Hari Head of Medical Engineering Zelgstrasse 8 CH8583 Sulgen, Switzerland

Re: K141879

Trade/Device Name: Belimed Steam Sterilizer MST-H Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 18, 2015 Received: May 20, 2015

Dear Mr. Hari,

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 Federal Register.

1

Page 2 - Mr. Hari

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number:

K141879

Device Name: Belimed Steam Sterilizer MST-H

Indications for Use

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H, models 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.

Type of Use (Select one or both, as applicable) □ Prescription Use (Part 21 CFR 801 Subpart D) 区 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

The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:

Cycle	Pre-treatment	Sterilizing temperature	Sterilizing Time 1)	Drying time 2)	Recommended load 3)
PreVac 270
4S/30D	5 pulses	270 °F	4 min	30 min	Double wrapped instrument
trays, max. weight of 25 lbs
per tray, Fabric packs
PreVac 270
4S/5D	5 pulses	270 °F	4 min	5 min	Fabric packs

| PreVac 275
3S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrument
trays, max. weight of 25 lbs
per tray, Fabric packs |
| Bowie-Dick
Test | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 270
15S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrument
trays, with non-porous
instruments, max. weight of
25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml in
vented or open containers 5) |
| Air leak Test | Vacuum: 65mbar
Test time: 15 min | - | - | - | Empty chamber |
| Warm up & Air
Leak Test | Vacuum: 65mbar
Test time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270 °F | 3 min | 3 min | Empty chamber |

Table 1: Factory programmed Sterilization cycles

Notes for Table 1:

1. Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
1. Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
1. Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
1. Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
1. Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.

4

| Model | Instrument trays,
max. 25 Ibs each | Fabric Packs,
max. 3.3 lbs each |
|--------|---------------------------------------|------------------------------------|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |

The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:

Table 2: Recommended loads for non-porous and porous load cycles

Model	Volume of liquid in one container	Number of containers
9-6-12	1000 ml	168
9-6-15	1000 ml	210
9-6-18	1000 ml	252

Table 3: Recommended loads for liquid cycle 250 °F

The Belimed Steam Sterilizer MST-H is offered in the following models:

| Model | Configuration | Net loading
capacity (L) | Chamber size
(H x W x D) (mm) | Overall Dimensions
(H x W x D) (mm) |
|------------|---------------|-----------------------------|----------------------------------|----------------------------------------|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |

Table 4: Models and dimensions

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510(k) Summary

Date:	June 10, 2015
Submitter's Name / Address:	Belimed Sauter AG
Zelgstrasse 8
CH- 8583 Sulgen / Switzerland
Contact Person:	Michael Hari
Email: michael.hari@belimed.ch
Phone: +41 71 644 86 37
Fax: +41 71 644 85 11
Trade Name:	Belimed Steam Sterilizer MST-H
Models:	9-6-12, 9-6-15 and 9-6-18
Classification:	Steam Sterilizer – Class II, as listed per 21 CFR 880.6880
Product Code: FLE
Predicate Device:	Belimed Steam Sterilizer TOP 5000
Series 9-18 (K021223)

INTENDED USE:

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

DESCRIPTION OF DEVICE:

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.

The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

6

The Belimed Steam Sterilizer MST-H is offered with the following factory-programmed predefined sterilization cycles:

| Cycle | Pre-treatment | Sterilizing
temperature | Sterilizing
Time 1) | Drying
time 2) | Recommended load
3) |
|----------------------------|-------------------------------------|----------------------------|------------------------|-------------------|-------------------------------------------------------------------------------------------------------|
| PreVac 270
4S/30D | 5 pulses | 270 °F | 4 min | 30 min | Double wrapped instrument
trays, max. weight of 25 lbs
per tray, Fabric packs |
| PreVac 270
4S/5D | 5 pulses | 270 °F | 4 min | 5 min | Fabric packs
4) |
| PreVac 275
3S/30D | 5 pulses | 275 °F | 3 min | 30 min | Double wrapped instrument
trays, max. weight of 25 lbs
per tray, Fabric packs |
| Bowie-Dick
Test | 5 pulses | 273 °F | 3.5 min | 1 min | One Bowie-Dick-Test-Pack |
| Gravity 270
15S/30D | Purge | 270 °F | 15 min | 30 min | Double wrapped instrument
trays, with non-porous
instruments, max. weight of
25 lbs per tray |
| Liquid 250 45S | Purge | 250 °F | 45 min | 0 min | Liquids, up to 1000 ml in
vented or open containers 5) |
| Air leak Test | Vacuum: 65mbar
Test time: 15 min | - | - | - | Empty chamber |
| Warm up & Air
Leak Test | Vacuum: 65mbar
Test time: 15 min | 270 °F | 3 min | 3 min | Empty chamber |
| Warm up | 2 pulses | 270°F | 3 min | 3 min | Empty chamber |

Table 1: Factory programmed Sterilization cycles

Notes for Table 1:

1. Only factory set sterilizing time should be utilized with medical devices intended for patient contact.
1. Factory set drying time. These are the minimum validated drying times, which may be extended depending on load conditions and wraps.
1. Recommended load: Refer to table 2 and 3. The load configurations listed in table 2 and 3 are those used during performance testing of the sterilizer models.
1. Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
1. Liquid cycle is not intended to sterilize liquids that are used for direct patient contact.

| Model | Instrument trays,
max. 25 lbs each | Fabric Packs,
max. 3.3 lbs each |
|--------|---------------------------------------|------------------------------------|
| 9-6-12 | 16 | 32 |
| 9-6-15 | 20 | 40 |
| 9-6-18 | 24 | 48 |

The following tables show the recommended loads for the Belimed Steam Sterilizer MST-H:

Table 2: Recommended loads for non-porous and porous load cycles

7

| Model | Volume of liquid in one
container | Number of containers |
|--------|--------------------------------------|----------------------|
| 9-6-12 | 1000 ml | 168 |
| 9-6-15 | 1000 ml | 210 |
| 9-6-18 | 1000 ml | 252 |

Table 3: Recommended loads for liquid cycle 250 °F

The Belimed Steam Sterilizer MST-H is offered in the following models:

| Model | Configuration | Net loading
capacity (L) | Chamber size
(H x W x D) (mm) | Overall Dimensions
(H x W x D) (mm) |
|------------|---------------|-----------------------------|----------------------------------|----------------------------------------|
| 9-6-12 HS1 | 1 door | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-12 HS2 | 2 doors | 691 | 1080 x 660 x 1398 | 1970 x 1700 x 1714 |
| 9-6-15 HS1 | 1 door | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-15 HS2 | 2 doors | 864 | 1080 x 660 x 1706 | 1970 x 1700 x 2022 |
| 9-6-18 HS1 | 1 door | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |
| 9-6-18 HS2 | 2 doors | 977 | 1080 x 660 x 2014 | 1970 x 1700 x 2330 |

Table 4: Models and dimensions

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NONCLINICAL COMPARISON TO PREDICATE DEVICE:

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are very similar to the predicate device.

A summary of the differences to the predicate device is included in Table 5 :

| General Sterilizer
Features | Belimed Steam Sterilizer
TOP5000
Series 9-18 (K021223) | Belimed Steam Sterilizer
MST-H | Substantially
Equivalent or
Different |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Terminal Sterilization of non-
porous and porous heat and
moisture-stabile materials used in
healthcare facilities | Terminal Sterilization of non-
porous and porous heat and
moisture-stabile materials used
in healthcare facilities | Same |
| Operating Principle | The sterilizing agent of the
Belimed Sterilizers MST-H is
steam. Steam is made from
demineralized water and is
therefore non-toxic. Steam is the
preferred method to sterilize
porous an non-porous heat
resistant materials and textiles in
hospitals for more than 100 years.
Preferred sterilization
temperatures are 250 °F, 270 °F
and 275 °F. | The sterilizing agent of the
Belimed Sterilizers MST-H is
steam. Steam is made from
demineralized water and is
therefore non-toxic. Steam is the
preferred method to sterilize
porous an non-porous heat
resistant materials and textiles in
hospitals for more than 100
years. Preferred sterilization
temperatures are 250 °F, 270 °F
and 275 °F. | Same |
| Product code | FLE | FLE | |
| C.F.R: code | 880.6880 Steam Sterilizer | 880.6880 Steam Sterilizer | |
| Class | II | II | |
| Built according to
Standard | ANSI/AAMI ST8:1994
Hospital Steam Sterilizers | ANSI/AAMI ST8:2013
Hospital Steam Sterilizers | Substantially
Equivalent,
(ST8:2013 uses
heavier instrument
load and refers to
new standard
versions) |
| Electrical safety
standard | UL 3101-1
IEC 61010-1 ed1, am1
IEC 61010-2-041 de1 | UL IEC 61010-1: 2004,
IEC 61010-2-040:2005 | Substantially
Equivalent |
| EMC conformity | IEC / EN 61326:2001 / 2002 | IEC / EN 61326:2001 / 2002 | Same |
| Electrical supply | 3 Phase 208V, 60Hz | 3 Phase 208V, 60Hz | |
| 9-6-9 &9-6-12 | Max. current: 13A | Max. current: 13A | Same |
| 9-6-15 & 9-6-18 | Max. current: 20A | Max. current: 20A | |
| Utility supply pressure
requirement
Steam
Water
Compressed air | 2.5 - 3 bar g
2 – 5 bar g
5 - 7 bar g | 2.5 - 3.5 bar g
2 – 5 bar g
5 – 7 bar g | Substantially
Equivalent |
| Steam capacity
requirement:
Model 9-6-9
Model 9-6-12
Model 9-6-15
Model 9-6-18 | 120 kg/h
160 kg/h
200 kg/h
240 kg/h | n/a
100 kg/h
120 kg/h
170 kg/h | Lower,
Substantially
Equivalent |
| Compressed air
capacity requirement: | 10 Nm³/h | 10 Nm³/h | Same |
| Cooling water
requirement:
Model 9-6-9
Model 9-6-12
Model 9-6-15
Model 9-6-18 | 2 m³/h
2.5 m³/h
3 m³/h
3.5 m³/h | n/a
2.4 m³/h
2.8 m³/h
3.2 m³/h | Lower,
Substantially
Equivalent |
| Control devices | | | |
| Vacuum device
Model 9-6-9, 9-6-12
Model 9-6-15, 9-6-18 | Water-ring vacuum pump
90 m³/h
125 m³/h | Water-ring vacuum pump
90 m³/h
125 m³/h | Same |
| Additional gas ejector /
sterilizer runs with
max. cooling water
temperatures | No/
80 °F | Yes, if optional cooling water
loop is not installed
90 °F | Substantially
Equivalent |
| Steam condenser | Shell-and-tube heat exchanger,
stainless steel | Shell-and-tube heat exchanger,
stainless steel | Substantially
Equivalent |
| Air Filtration | 0,2µm, efficiency >99.5%

99.97% for 0.3-micron particles | 0,2µm, efficiency >99.5%
99.97% for 0.3-micron particles | Same |
| Control valves
for steam, vacuum and
condensate | Stainless steel grade 316 L
pneumatically driven piston-valves | Stainless steel grade 316 L
pneumatically driven piston-
valves | Substantially
Equivalent |
| Control valves for
cooling water | Brass
Electric solenoid valves | Fiber-reinforced plastic material
Electric solenoid valves | Substantially
Equivalent |
| Piping material grade | AISI 316L | AISI 316L | Same |
| Pressure vessel | | | |
| Chamber and jacket
material grade | AISI 316L | AISI 316L | Same |
| Chamber construction | Cubic welded structure with all-
round heating ducts | Cubic welded structure with all-
round heating ducts | Same |
| Chamber design
pressure | 39psi | 40psi | Substantially
Equivalent |
| Safety valves | Bronce, ASME approved | Bronce, ASME approved | Same |
| Chamber design
standard | ASME Section VIII, Division 1, for
unfired pressure vessels | ASME Section VIII, Division 1, for
unfired pressure vessels | Same |
| Door material grade | AISI 321 | AISI 321 | Same |
| Door opening | Single or double door
Horizontal door operation
Motor driven | Single or double door
Horizontal door operation
Motor driven | Substantially
Equivalent |
| Door safety:
Door safety bar
Additional door locking
fixture
Number of door limit
switches | Yes
No
Two 'door closed' switches per
door | Yes
Yes
one 'door closed' switch per door
and one 'door closed &
mechanically locked' switch per
door | Substantially
Equivalent |
| Door seal | Compressed air activated | Compressed air activated | Same |
| Chamber sizes
Model:
9-6-9
9-6-12
9-6-15
9-6-18
Control | (H x W x D) in mm:
1080x660x1040
1080x660x1400
1080x660x1700
1080x660x2000 | (H x W x D) in mm:
Not available
1080x660x1398
1080x660x1706
1080x660x2014 | Substantially
Equivalent |
| Control Technology | PLC | PLC | same |
| HMI Technology
loading side | LCD color / 5,7" | TFT color 10" | Different, larger
display |
| HMI Technology
unloading side | BT2-2004 LCD display /
h x w = 35mm x 68mm | LSC display /
h x w=27mmx100mm | Substantially
Equivalent |
| Printer Technology | Matrix Dot technology
42 char /line, paper width 57mm | Thermal technology
42 char /line, paper width 57mm | Substantially
Equivalent
(same Information
on printout) |
| Process control | Automatic through all phases of a
cycle | Automatic through all phases of a
cycle | Same |
| Sterilization process
control | Pressure controlled by an
absolute pressure transmitter | Pressure controlled by an
absolute pressure transmitter | Same |
| Sterilization process
recording | Independent temperature and
pressure sensors for recording | Independent temperature and
pressure sensors for recording | Same |
| Sterilization process
monitoring | Temperature sensor for exposure
temperature monitoring | Temperature sensor for exposure
temperature monitoring | Same |
| Process alarms | Detected errors cause an acoustic
and visual alarm. Alarms are
recorded on the printer.
At cycle end the door on the
unloading side (double door
models) can't be opened. Alarms
must be manually acknowledged
on the load side operating panel. | Detected errors cause an
acoustic and visual alarm. Alarms are
recorded on the printer.
At cycle end the door on the
unloading side (double door
models) can't be opened. Alarms
must be manually acknowledged
on the load side operating panel. | Same |
| Cycle phases | All cycle phases and sterilizer status are monitored on display. Display of:
-Chamber temperature & pressure
-Process status
-Door status
-Alarms, if pending | All cycle phases and sterilizer status are monitored on display. Display of:
-Chamber temperature & pressure
-Process status
-Door status
-Alarms, if pending
Additional process status display for cycle state above the chamber (LED bar display) | Substantially
Equivalent
(Additional
information) |
| Cycle end | Acoustic signal at cycle end
Cycle end Indication on operating panel display. | Acoustic signal at cycle end
Cycle end Indication on operating panel display. | Same |
| Performance: | | | |
| Biological performance | SAL of 10-6 reduction | SAL of 10-6 reduction | |
| (half cycle) | Through achievement of no growth at half cycle with validation loads.
AAMI ST8:1994 | Through achievement of no growth at half cycle with
validation loads.
AAMI ST8:2013 | Same |
| Comply with | | | |
| Moisture retention | Fabrics: