(148 days)
U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change
The U&U Bowie-Dick Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST66. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.
Here's an analysis of the provided text regarding the U&U Bowie-Dick Test Pack, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Item | Code Requirement | Reported Device Performance |
|---|---|---|
| Visual inspection | Inspect the Cleanliness of Bowie-dick test pack. | PASS |
| Dimensions | Width: 140±1mmLength: 140±1mmHeight: 18±1mm | PASS |
| Endpoint Color | Dark brown/black | Black |
| Indicator Format | The bowie-dick internal indicator ink shall beuniformly distributed on its substrate paper tocover not less than 30 % of the test area of thesubstrate paper. the indicator ink printed / thesubstrate paper ≥ 30% | 66% |
| Indicator Color Change Performance | The bowie-dick internal indicator system shallshow a uniform color after exposure to saturatedsteam at 134°C for 3.5 min. | PASS |
| Internal Indicator Color Change Fault Performance | Color change fault condition (the temperature atthe center of the bowie-dick test pack is 2°Clower than the temperature of the chamber drainat the beginning of the final 1 min of a 3.5 mincycle at 134 °C). After exposure to conditionsused to produce a color change fault condition inthe bowie-dick test pack. the internal indicatorshall show a non-uniform color change. | PASS |
| Air Permeance Performance | The bowie-dick test pack shall have an airporosity not less than 1.7 µm/(Pa·s) when testedin accordance with ISO 5636-3 at an air pressureof 1.47 kPa | PASS |
| Toxicity (In Vitro Cytotoxicity - MTT cytotoxicity test) | Under the conditions of cytotoxicity study, the viability of 100% extract of the test article was 76 %. It can be considered that the article extracts had not a cytotoxic potential. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of Bowie-Dick test packs) used for each performance test condition (e.g., number of units tested for temperature difference, number for steam exposure, etc.). It generally refers to "performance testing in dynamic-air-removal steam sterilizer, biocompatibility, storage condition, shelf life."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to have been generated internally by the manufacturer during "validation studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and therefore not provided in the document. The device (Bowie-Dick Test Pack) is a chemical indicator designed to demonstrate a physical change (color change) based on specific sterilization conditions. The ground truth is established by the physical and chemical properties of the indicator and its interaction with steam and air, not by expert human interpretation of a complex image or data set. The "PASS" result for each test indicates objective measurement against a defined standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on physical and chemical reactions observable against defined criteria, not on subjective interpretation requiring 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 device is a chemical indicator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study is not relevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical and chemical design.
7. The Type of Ground Truth Used
The ground truth used is primarily based on objective measurement against established physical and chemical standards and conditions. Specifically:
- Engineering and Material Specifications: Dimensions, air permeance, indicator format (ink coverage).
- Defined Sterilization Parameters: Saturated steam at 134°C for 3.5 minutes.
- Defined Fault Conditions: 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack and the drain temperature.
- Biocompatibility Standards: In vitro cytotoxicity results (e.g., cell viability percentage).
- Visual Color Change: Objective observation of color change to dark brown/black or non-uniform change.
These are derived from internationally recognized standards such as ANSI/AAMI/ISO 11140-5, AAMI ST66, and ISO 5636-3.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a training set. The performance is based on its physical design and chemical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2015
U&U Medical Technology Co., Ltd. C/O Ms. Li Qian Official Correspondent CARELIFE (USA), Inc. 1580 Boggs Rd. Suite 500/600 Duluth, Georgia 30096
Re: K143629
Trade/Device Name: U&U Bowie-Dick Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator/Physical/Chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: April 15, 2015 Received: April 20, 2015
Dear Ms. Li Qian:
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 - Ms. Li Qian
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 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/Resourcesfor You/Industry/default.htm. 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 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K143629
Device Name U&U Bowie-Dick Test Pack
Indications for Use (Describe)
U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
Rev 0.03 15/05/15
Sec 005_510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
Date Prepared: 2015-05-15 Submission Numbers for Pre-Submission: K143629
1. Submitter Name and Address:
| Name: | U&U Medical Technology Co., Ltd |
|---|---|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,ChinaRM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China |
| Contactor Name: | Garfield Wang |
| TEL: | +86-13902471751 |
| E-mail: | Wangxuebo_11@hotmail.com |
US Agent:
| Name: | CARELIFE (USA) INC. |
|---|---|
| Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 |
| TEL: | 404 6612228 |
| Contact person : | Ms. LI QIAN liqian@shanghaicarelife.com |
2. Submission Devices Information:
Trade/Proprietary Name: U&U Bowie-Dick Test Pack Common Name: Bowie-Dick Test Pack Classification name: indicator, physical/chemical sterilization process Class: II FDA review panel code: General Hospital Product code: JOJ Regulation Number: 21 CFR 880.2800
3. Predicate Devices Information:
| Trade Name: | 3M Comply Bowie-Dick Type Lead Free Test Pack |
|---|---|
| 510(K) Number: | K093199 |
| Manufacturer: | 3M Health Care |
4. Devices Description:
The U&U Bowie-Dick Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST66. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.
Model Number:
{4}------------------------------------------------
510(k) Submission
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EÈ1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Bowie-Dick Test Pack]
Rev 0.03 15/05/15
| RefNumber | ModelNumber | Description | Size |
|---|---|---|---|
| UUBD0001 | UUBDTP | U&U Bowie-Dick Test Pack | 140X140X18mm |
5. Intended Use:
U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-airremoval prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change
6. Technical Design and Performance Characteristics:
The U&U Bowie-Dick Test Pack uses impermeable lavers on the top and bottom to direct steam and enhances the air capture qualities. A precisely controlled pad of porous substrate is used to establish a matrix for the formation of an air bubble and to act as a reservoir of air simulating the towels in a conventional large towel pack.
The reticulated foam layer acts as a steam pathway for the control of air bubble alignment and insulates the indicator from radiant heat emanating from the hot surface of the sterilizer chamber. Air is evacuated from the chamber and the test pack during the pre-vacuum cycle. If an air leak is present, air will bleed back into the chamber as a vacuum is pulled. Since air is much cooler and heavier than steam, it will be forced to the bottom of the chamber near the drain when the steam valves opens. As pressure begins to increase, the air and then the steam enters the pack from the sides and top of the reticulated foam pathway at the top of the pack. The steam pressure compresses the air into a bubble and pushes it toward the bottom of the pack. As the steam pressure increases, the air bubble is squeezed smaller and smaller until the pressure stabilizes.
7. SUBSTANTIAL EQUIVALENCE DISCUSSION:
U&U Medical Technology Co., Ltd is claiming substantial equivalence for its U&U Bowie-Dick Test Pack to the 3M Comply Bowie-Dick Type Lead Free Test Pack (K093199) based on test data obtained during validation studies. We have demonstrated with testing that the U&U Bowie-Dick Test Pack performs consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C (+1° /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5. Under these conditions, the indicator sheet would demonstrate a non-uniform color change. The U&U Bowie-Dick Test Pack is also comparable to other commercially available Bowie Dick test packs cleared by the FDA.
Comparison table:
| Element ofComparison | Submission Device | Predicate Device K093199 |
|---|---|---|
| Intended Use | U&U Bowie-Dick Test Pack are designedfor testing air removal efficiency of | The 3MTM Comply Tm Bowie-Dick Type LeadFree Test Pack is designed for testing air |
| dynamic-air-removal prevacuum steamsterilizers operating at 134 °C (273°F) for3.5 minutes. The U&U Bowie-Dick TestPack is for single use and will demonstratea uniform color change from yellow to darkbrown/black when proper sterilizationconditions are met and no air is present. Ifenough air is present to create a 2°C (+1°/-0°C) temperature difference between thecenter of the Bowie-Dick Test Pack, asidentified in ANSI/AAMI/ISO 11140-5, andthe drain temperature at the beginning ofthe final one minute of a three and halfminute cycle the U&U Bowie-Dick TestPack will demonstrate a non-uniform colorchange | removal efficiency of 132- 134 °C(270- 273 F )dynamic-air-removal steam sterilizers. | |
| Raw Materials | Impermeable Layer - Frame BoardReticulated Foam - PolyurethanePorous Substrate - Food Packaging BoardIndicator Sheet - Indicator ink & paperDisposable Wrap - Polypropylene WrapLabel - Paper & Hotmelt Adhesive | Impermeable Layer - Frame BoardReticulated Foam - PolyurethanePorous Substrate - Food Packaging BoardIndicator Sheet - Inicator ink & paperDisposable Wrap - Polypropylene WrapLabel - Paper & Hotmelt Adhesive |
| Indicator Agent | Indicator Ink - Lithium carbonate (5-10%),Triethylamine(1-5%) , Normal Propanol(1-5%) | Indicator Ink - unknown |
| ChemicalIndicator Type | Air Removal Indicator For Test Pack | Air Removal Indicator For Test Pack |
| Endpoint Color | Dark brown/Black | Dark brown/Black |
| SterilizationMethod | dynamic-air-removal steam sterilizer | dynamic-air-removal steam sterilizer |
| Indictor ColorChangePerformance | The bowie-dick internal indicator systemshall show a uniform color after exposureto saturated steam at 134°C for 3.5 min. | The bowie-dick internal indicator system shallshow a uniform color after exposure to saturatedsteam at 134°C for 3.5 min. |
| InternalIndicator ColorChange FaultPerformance | Color change fault condition (thetemperature at the center of the bowie-dick test pack is 2°C lower than thetemperature of the chamber drain at thebeginning of the final 1 min of a 3.5 mincycle at 134 °C). After exposure toconditions used to produce a color changefault condition in the bowie-dick test pack.the internal indicator shall show a non-uniform color change. | Color change fault condition (the temperature atthe center of the bowie-dick test pack is 2°Clower than the temperature of the chamber drainat the beginning of the final 1 min of a 3.5 mincycle at 134 °C). After exposure to conditionsused to produce a color change fault condition inthe bowie-dick test pack. the internal indicatorshall show a non-uniform color change. |
| RecommendedStorageConditions: | Store in a dry (<50% RH) condition at roomtemperature [15-30°C (59-86°F)] andprotect from direct light. Do not store nearstrong alkaline or acidic products such ascleaning or disinfecting agents. After usethe indicator will not change visually within24 months when stored at above conditions. | Store in a dry (<50% RH) condition at roomtemperature [15-30°C (59-86°F)] and protectfrom direct light. Do not store near strongalkaline or acidic products such as cleaning ordisinfecting agents. After use the indicator willnot change visually within 24 months whenstored at above conditions. |
| Shelf Life | The U&U BOWIE-DICK Test Pack has a 2-year shelf life from the date of manufacturewhen stored at recommended conditions.The expiration date is printed on the labelthat secures the test pack. | The 3M™ Comply™ Bowie-Dick Type Lead FreeTest Pack has a 2-year shelf life from the date ofmanufacture when stored at recommendedconditions. The expiration date is printed on thelabel that secures the test pack. |
{5}------------------------------------------------
510(k) Submission
U&U ChangZhou Medical Packaging Technology Co., Ltd
Dongzhou Village,Hengshanqiao,Changzhou,Liangsu,China
U&U (Shanghai) Medical Technology Co., Limited
RM EE1002 1/F Buildin
15/05/15 Rev 0.03
{6}------------------------------------------------
U&U ChangZhou Medical Packaging Technology Co., Ltd
Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China
U&U (Shanghai) Medical Technology Co., Limited
RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China
[Bowie-Dick Test Pack]
| PackageMaterial | Paper Box |
|---|---|
| --------------------- | ----------- |
| Paper Box | |
|---|---|
| -- | ----------- |
510(k) Submission
Rev 0.03 15/05/15
8. Recommended Storage Conditions:
Store in a dry (<50% RH) condition at room temperature [15-30°C (59-86°F)] and protect from direct light. Do not store near strong alkaline or acidic products such as cleaning or disinfecting agents. After use the indicator will not change visually within 24 months when stored at above conditions.
9. Non-Clinical Testing:
Validation of the U&U Bowie-Dick Test Pack included performance testing in dynamic-airremoval steam sterilizer, biocompatibility, storage condition, shelf life. All results, from testing meet the predetermined acceptance criteria.
All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Premarket Notification [5 10(k)] Submissions for Chemical Indicators,". And AAMI ST66: Sterilization of healthcare products - Chemical indicators - Part 2: Class 2 indicators for air removal test. And AAMI/ANSI/ISO 11140-5 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal test sheets and packs
| Testing Items | Code Requirement | Test Result |
|---|---|---|
| Visual inspection | Inspect the Cleanliness of Bowie-dick test pack. | PASS |
| Dimensions | Width: 140±1mmLength: 140±1mmHeight: 18±1mm | PASS |
| Endpoint Color | Dark brown/black | Black |
| Indicator Format | The bowie-dick internal indicator ink shall beuniformly distributed on its substrate paper tocover not less than 30 % of the test area of thesubstrate paper. the indicator ink printed / thesubstrate paper ≥ 30% | 66% |
| Indicator ColorChangePerformance | The bowie-dick internal indicator system shallshow a uniform color after exposure to saturatedsteam at 134°C for 3.5 min. | PASS |
| Internal IndicatorColor Change FaultPerformance | Color change fault condition (the temperature atthe center of the bowie-dick test pack is 2°Clower than the temperature of the chamber drainat the beginning of the final 1 min of a 3.5 mincycle at 134 °C). After exposure to conditionsused to produce a color change fault condition inthe bowie-dick test pack. the internal indicatorshall show a non-uniform color change. | PASS |
| Air PermeancePerformance | The bowie-dick test pack shall have an airporosity not less than 1.7 µm/(Pa·s) when testedin accordance with ISO 5636-3 at an air pressureof 1.47 kPa | PASS |
| Toxicity | Non-toxic; In Vitro Cytotoxicity (MTT cytotoxicitytest) Test Result: Under the conditions ofcytotoxicity study, the viability of 100% extract of | PASS |
{7}------------------------------------------------
510(k) Submission
15/05/15
Rev 0.03
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Bowie-Dick Test Pack]
| the test article was 76 %. It can be consideredthat the article extracts had not a cytotoxicpotential. | ||
|---|---|---|
| ---------------------------------------------------------------------------------------------------------------- | -- | -- |
10. Conclusion:
U&U Medical Technology Co., Ltd is claiming substantial equivalence for its U&U Bowie-Dick Test Pack to the 3M Comply Bowie-Dick Type Lead Free Test Pack (K093199) based on test data obtained during validation studies. We have demonstrated with testing that the U&U Bowie-Dick Test Pack performs consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C (+1° /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5. Under these conditions, the indicator sheet would demonstrate a non-uniform color change.
11. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject U&U Bowie-Dick Test Pack is substantially equivalent and is as safe and as effective as the legally marketed predicate device, 3M Comply Bowie-Dick Type Lead Free Test Pack cleared under K093199'.
END
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).