LogoFDA 510(k) Search
K Number
K202524
Device Name
Standard Sterilizable Tray
Manufacturer
Implant Direct Sybron Manufacturing, LLC
Date Cleared
2021-01-28

(149 days)

Product Code
KCT
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time. - (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time. - The tray is intended for sterilization of non-porous loads. - Do not stack trays during sterilization. - The tested Tray represents the worst case validated load of 667.52 grams. - Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
Device Description
The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray. The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.
More Information

K200858

Not Found

No
The device is a physical tray for organizing and sterilizing dental instruments. The description focuses on materials, dimensions, and sterilization parameters, with no mention of software, algorithms, or data processing.

No.
The device is a sterilizable tray designed to organize, steam sterilize, and transport dental instruments, not to directly treat or diagnose a medical condition.

No

The device is a tray designed to organize, steam sterilize, and transport dental instruments. It does not perform any diagnostic functions.

No

The device description clearly outlines physical components made of polyphenylsulfone and silicone rubber, indicating it is a hardware device, not software only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
  • Device Function: The Standard Sterilizable Tray is designed to hold, organize, and sterilize dental instruments. Its function is to prepare instruments for use on a patient, not to analyze samples from a patient.
  • Intended Use: The intended use clearly states it's for holding, organizing, steam sterilizing, and transporting dental surgical and prosthetic instruments. This is a function related to the preparation and handling of medical devices, not diagnostic testing.
  • Device Description: The description details the materials and components of a tray designed for holding instruments, not for performing diagnostic tests.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples
    • Detecting specific analytes (e.g., glucose, antibodies, DNA)
    • Providing diagnostic information about a patient's condition

Therefore, based on the provided information, the Standard Sterilizable Tray is a medical device used for the processing of other medical devices, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
(2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.

  • The tray is intended for sterilization of non-porous loads.
  • Do not stack trays during sterilization.
  • The tested Tray represents the worst case validated load of 667.52 grams.
  • Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

Product codes

KCT

Device Description

The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.

The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.

The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.

The Standard Sterilizable Tray is available either empty or loaded with surgical and prosthetic instruments to support endosseous dental implants and abutments that are not subject devices to this submission. The empty tray, along with a complete load of instruments, weighs a maximum of 667.52 grams. The variable Inner Tray offers two configuration options to allow for the assembly of supporting surgical and prosthetic instruments.

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

Not Found

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)

The device underwent non-clinical testing for:

  • Biocompatibility (ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity): Passed, observed morphological grade 2 (mild) or better.
  • Continued performance during useful life (ISO 17664 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices): Passed, no visual degradation, silicone retention performance.
  • Effectiveness of recommended cleaning process (TIR30- A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices And TIR 12- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers): Passed,

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

January 28, 2021

Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362

Re: K202524

Trade/Device Name: Standard Sterilizable Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 21, 2020 Received: December 28, 2020

Dear Reina Choi:

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.

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

1

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 (OS) 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,

for Clarence W. Murray, III, PhD Acting 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) K202524

Device Name Standard Sterilizable Tray

Indications for Use (Describe)

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

  • (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.

  • The tray is intended for sterilization of non-porous loads.

  • Do not stack trays during sterilization.

  • The tested Tray represents the worst case validated load of 667.52 grams.

  • Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

| Model Name | Model
Number | Max # of
Instruments | Max Load (g) | Vent to volume
Ratio (in⁻¹) |
|---------------------------------|-----------------|-------------------------|--------------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | | 385.2 | 0.021 |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | | 384.2 | 0.021 |

Type of Use (Select one or both, as applicable)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

_ Prescription Use (Part 21 CFR 801 Subpart D)

3

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4

K202524

510(k) Summary

I. SUBMITTER

Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Contact Person: Reina Choi, Requlatory Affairs Manager E-mail: reina.choi@implantdirect.com Phone: (818) 307-3132

Date Prepared: January 27, 2021

II. DEVICE

Name of Device: Standard Sterilizable Tray Common or Usual Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Classification Name: Sterilization Wrap (21 CFR 880.6850) Requlatory Class: II Product Code: KCT

III.PREDICATE DEVICE

Primary Predicate: Mini Sterilizable Tray (K200858)

IV. DEVICE DESCRIPTION

The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.

The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.

The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.

5

| Model name | Model
number | Max # of
Instruments | Max load
(g) | Vent to volume
ratio (in⁻¹) |
|------------------------------|-----------------|-------------------------|-----------------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| InterActive™ Surgical
Kit | CISK | 34 | 662.70 | 0.021 |

The Standard Sterilizable Tray is available either empty or loaded with surgical and prosthetic instruments to support endosseous dental implants and abutments that are not subject devices to this submission. The empty tray, along with a complete load of instruments, weighs a maximum of 667.52 grams. The variable Inner Tray offers two configuration options to allow for the assembly of supporting surgical and prosthetic instruments.

V. INDICATIONS FOR USE

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

  • (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
  • The tray is intended for sterilization of non-porous loads.
  • Do not stack trays during sterilization.
  • The tested Tray represents the worst case validated load of 667.52 grams.
  • Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

| Model Name | Model
Number | Max # of
Instruments | Mass(g) | Vent to volume
Ratio (in⁻¹) |
|---------------------------------|-----------------|-------------------------|---------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | | 385.2 | 0.021 |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | | 384.2 | 0.021 |

6

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| Technological
characteristics | Subject Device
(K202524) | | Primary Predicate
(K200858) | | Comparison | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-----------|
| | Standard Sterilizable Tray | | Mini Sterilizable Tray | | | |
| Manufacturer | Implant Direct Sybron Manufacturing, LLC | | Implant Direct Sybron Manufacturing, LLC | | Same | |
| General design | Plastic tray with locking lid co-molded silicone and
silicone grommet supports and stainless steel
component | | Plastic tray with locking lid co-molded
silicone and silicone grommet supports
and stainless steel components | | Same | |
| Dimensions | 7.3 in x 5.5 in x 2.4 in | | 5.5 in x 4.0 in 2.25 in | | Different | |
| Materials | Base - Radel 5000
Lid - Radel 5000
Inner tray - Radel 5000
Tooling support - Silicone
Pan - Stainless steel | | Base - Radel 5000
Lid - Radel 5000
Inner tray - Radel 5000
Tooling support - Silicone
Pan - Stainless steel
Bracket - Stainless steel | | Same | |
| Air permeance | Yes | | Yes | | Same | |
| Design Characteristic | Maximum
number of
instruments | CSSK | 46 | CSSKM | 21 | Different |
| | | CISK | 34 | CISKM | 20 | |
| | | | | CDSKL | 36 | |
| | | | | CDSKS | 32 | |
| | | | | CPKM | 14 | |
| | Mass of
maximum
sterilization load | CSSK | 667.52g | CSSKM | 278.50 g | Different |
| | | CISK | 662.70g | CISKM | 276.60 g | |
| | | | | CDSKL | 354.10 g | |
| | | | | CDSKS | 209.10 g | |
| | | | | CPKM | 262.55 g | |
| | Vent to volume
ratio | CSSK | 0.021 in-1 | CSSKM | 0.082 in-1 | Different |
| | | CISK | 0.021 in-1 | CISKM | 0.082 in-1 | |
| | | | | CDSKL | 0.087 in-1 | |
| | | | | CDSKS | 0.087 in-1 | |
| | | | | CPKM | 0.087 in-1 | |

7

| Technological
characteristics | | Subject Device
(K202524)
Standard Sterilizable Tray | | | Primary Predicate
(K200858)
Mini Sterilizable Tray | | Comparison | |
|----------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|-----------------|
| Sterility | | Non-sterile | | | Non-sterile | | Same | |
| Sterilization
method | | Moist heat gravity or pre vacuum | | | Moist heat gravity or pre vacuum | | Same | |
| Reusable | | Yes | | | Yes | | Same | |
| Intended use | | Perforated instrument cassette system to hold
dental instruments in place during transport, steam
sterilization, and storage | | | Perforated instrument cassette system
to hold dental instruments in place
during transport, steam sterilization, and
storage | | Same | |
| Indication for Use | | The Standard Sterilizable Tray is designed to hold
various dental surgical and prosthetic instruments
in order to organize, steam sterilize, and transport
the instruments between uses. The tray is to be
enclosed in an FDA cleared steam sterilizable
wrap (Maximum thickness KC300) and sterilized
in an FDA cleared sterilizer for one of the
following cycles:

(1) Prevacuum Steam – At 132°C for 4 minutes
with a 20 minutes dry time.
(2) Gravity Steam – At 132°C for 15 minutes with
a 30 minutes dry time.

  • The tray is intended for sterilization of non-
    porous loads.
  • Do not stack trays during sterilization.
  • The tested Tray represents the worst case
    validated load of 667.52 grams.
  • Implant Direct Sybron Manufacturing LLC
    does not make any lumen claims for the
    Standard Sterilizable Tray. | | | The Mini Sterilizable Tray is designed to
    hold various dental surgical and
    prosthetic instruments in order to
    organize, steam sterilize, and transport
    the instruments between uses. The tray
    is to be enclosed in an FDA cleared
    steam sterilizable wrap and sterilized in
    an FDA cleared sterilizer for one of the
    following cycles:

(1) Prevacuum Steam – At 132°C for 4
minutes with a 20 minutes dry time.
(2) Gravity Steam - At 132°C for 15
minutes with a 30 minutes dry time.

  • The trays are intended for sterilization
    of non-porous loads.
  • Do not stack trays during sterilization.
  • The tested Tray represents the worst
    case validated load of 354.10 grams.
  • Implant Direct Sybron Manufacturing
    LLC does not make any lumen claims
    for the Mini Sterilizable Tray. | | Similar | |
    | | | Model
    Name | Model
    Number | Max #
    of | Mass
    (g) | Vent to
    volume | Model Name | Model
    Number |
    | Technological
    characteristics | Subject Device
    (K202524)
    Standard Sterilizable Tray | | | Primary Predicate
    (K200858)
    Mini Sterilizable Tray | | Comparison | | |
    | | | Instruments | Ratio
    (in-1) | | | | | |
    | | Standard
    Surgical Kit | CSSK | 46 | 667.52 | 0.021 | Standard Surgical Kit Mini
    CSSKM | | |
    | | Standard
    Surgical Kit
    Empty | SSK | | 385.2 | 0.021 | Standard Surgical Kit Mini
    Empty
    SSKM | | |
    | | InterActiveTM
    Surgical Kit | CISK | 34 | 662.70 | 0.021 | InterActiveTM Surgical Kit
    Mini
    CISKM | | |
    | | InterActiveTM
    Surgical Kit
    Empty | ISK | | 384.2 | 0.021 | InterActiveTM Surgical Kit
    Mini Empty
    ISKM | | |
    | | | | | | | Drill Stop Kit – Long
    CDSKL | | |
    | | | | | | | Drill Stop Kit – Long
    Empty
    DSKL | | |
    | | | | | | | Drill Stop Kit - Short
    CDSKS | | |
    | | | | | | | Drill Stop Kit - Short
    Empty
    DSKS | | |
    | | | | | | | Prosthetic Kit
    CPKM | | |
    | | | | | | | Prosthetic Kit Empty
    PKM | | |
    | | | | | | | Drill Stop Kit Bracket Set -
    Long
    DSK-
    BKTL | | |
    | | | | | | | Drill Stop Kit Bracket Set -
    Short
    DSK-
    BKTS | | |
    | | | | | | | Replacement Kit Pan
    PAN | | |

8

9

Comparison Between Subject Device and Predicate

The Standard Sterilizable Tray is larger in size than the predicate and made of same materials as the predicate. The use of Standard Sterilizable Tray has been validated through biocompatibility and sterilization testing. Therefore, this does not raise new questions of substantial equivalence.

The vent to volume ratio for the Standard Sterilizable Tray is 0.021 in 1 while the predicate vent to volume ratio is 0.087 in-1. While the Standard Sterilizable Tray has a lower vent to volume ratio, this has been demonstrated to not be an issue through sterilization validation testing.

The Standard Sterilizable Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the Standard Sterilizable Trav is 667,52g, while the predicate's maximum sterilization load is 354.10g. While the Standard Sterilizable Tray has a larger weight and more instruments, this has been demonstrated to not be an issue through sterilization testing and has been validated to assure a SAL of 10-6.

The Standard Sterilizable Trays and predicate device have the same intended use. The indication for use is the same except for and various versions of inner tray for the predicate and the weight of the validated trays.

| Testing

MethodologyPurposeAcceptance CriteriaResults
ISO 10993-5
Biological
evaluation of
medical devices —
Part 5: Tests for in
vitro cytotoxicityThe purpose of
the testing is to
observe the
cytoxicity
potential of the
device extract.Morphological Grade 2
(mild) or betterPass
ISO 17664
Processing of
health care
products —
Information to be
provided by the
medical device
manufacturer for
the processing of
medical devicesThe purpose of
this testing is to
verify the
continued
performance of
the device
during its
useful life.No visual degradation,
silicone retention
performancePass
TIR30- A
compendium of
processes,
materials, test
methods, and
acceptance criteria
for cleaning
reusable medical
devices
And TIR 12-
Designing, testing
and labeling
reusable medical
devices for
reprocessing in
health care
facilities: A guide
for medical device
manufacturersThe purpose of
this testing is to
verify the
effectiveness of
the
recommended
cleaning
process.