(528 days)
The predicate product was marketed prior to May 28. 1976
Not Found
No
The device is a chemical indicator strip that changes color based on physical conditions (temperature and time). The description explicitly states the basic formula and concept haven't changed significantly since 1932, and the performance evaluation relies on visual interpretation by human panels. There is no mention of any computational analysis, image processing, or learning algorithms.
No
This device is a chemical indicator strip used to verify that sterilization conditions were met in steam sterilizers. It does not exert any therapeutic effect on a patient.
No
This device is an indicator strip that shows whether sterilization conditions were met. It does not diagnose a medical condition or disease in a patient. Instead, it confirms the efficacy of a sterilization process for equipment.
No
The device is a chemical indicator strip, which is a physical product that changes color based on exposure to sterilization conditions. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the conditions within a steam sterilizer to ensure that sterilization parameters (temperature and time) were met. This is a quality control measure for the sterilization process itself, not a test performed on a biological sample from a patient to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a chemical indicator strip that changes color based on exposure to steam and temperature. This is a physical/chemical reaction, not a biological or biochemical test performed on a sample.
- Anatomical Site / Patient Age Range: These are listed as "Not Applicable," which is consistent with a device that does not interact with a patient.
- Input Imaging Modality / AI/ML Mentions: These are listed as "Not Applicable" or "Not Found," which are less common for IVDs that often involve analysis of biological samples, sometimes with imaging or AI assistance.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that definition. It is a process indicator for a medical device sterilization process.
N/A
Intended Use / Indications for Use
SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The SteriTec product is similar in design, composition and function to the:
ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam
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)
Laboratory tests were performed to substantiate and verify that the performance of the submitted Starilled product performed ins described These tests were performed by an independent testing laboratory.
Test 1 - Completed Sterilization Cycle:
3 Minutes (@) 132°C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the center of a steam bier vessel along with a spore strip and sterilized at 132°C. (270°F) for three minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips. The test spore strips from each run and the control spore strip were tested. All of the test spore strips showed a complete kill while the control strip showed all survivors. All indicator strips passed this test.
Test 2 - Incomplete Sterilization Cycle:
20 Seconds (a), 132 °C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the conter of a steam bier vessel along with a spore strip and sterilized at 132 °C (270°F) for only 20 seconds, to simulate improper sterilization conditions.
Results: All indicator strips showed incomplete color change (none turned to black), indicating improper sterilization conditions and proper functioning of the strips. The test spore strips for each run and the control spore strip were tested. All of the test spore strips and the control strip showed all survivors. All indicator strips passed this test.
Test 3 - Performance Data for Storage of Cross-Check Strips
A. Cross-Checks Strips stored under normal conditions:
SteriTec CROSS CHECKS sterilization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10 ~38°C (50-100°F) and humidity
Results: The strips were examined for correct indicator color (white). All strips appeared unchanged by the storage process.
B. Cross-Checks Strips stored under normal conditions than sterilized.
Sterilier CROSS-CHECKS sterifization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10°-38°C (50-100°F) and himidity. The indicator strips were placed in the center of a gravity steam sterilizer and sterilized at 121 "( (250°F) for fifteen minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by normal storage.
C. Cross-Checks Strips subjected to extreme tomperature.
SteriTec CROSS-CHECKS sterifization indicator strips were stored in a constant temperature chamber at 578 C. (134" F.) for eight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed and examined The color of the strip had NOT changed from its original normal white color.
D. Cross-Checks Strips subjected to extreme temperature then sterilized.
Cross-Check strips were stored in a constant temperature chamber at 57° C. (134" F.) for eight (8) days. Strips were placed in the conter of a gravity steam sterilizer and sterilized at 121 °C (250 "F) for fifteen minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance cansed by storage in extreme heat conditions.
E. Cross-Checks Strips subjected to extreme humidity.
SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jai was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days.
Results: Following storage the strips were removed and examined. The color of the strip had NOT changed from its original normal white color.
F. Cross-Checks Strips subjected to extreme humidity then sterilized.
SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The hell jar was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days. The indicator strips were placed in the center of a gravity steam sterilized and sterilized at 121 "C (250"F) for fillecn minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme humidity conditions.
G. Cross-Checks Strips subjected to extreme temperature and humidity.
SteriTec Cross-Check sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° F.) for cight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed und examined. The color of the strip had changed from its original white color to a light tan.
H. Cross-Checks Strips subjected to extreme temperature and humidity then sterilized.
SteriTec Cross-Check sterilization indicator stored in a vacuum desiceator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° I'.) for eight (8) days.
Results: Following the fifteen minute sterilization cycle, the test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme heat and humidity conditions.
Test 4 - Performance Data for Cross-Checks Strips sterilized at various sterilization temperatures and sterilization times:
(1) SteriTec Cross-Checks sterilization indicator strips catalog numbers CI 102 and CI 111 were subjected to a steam sterilization eveles for 3 minutes at the following sterilization temperatures: 124 °C, 128°C, 130°C, 132°C, 134°C. Approximately 300 strips along with 12 hiological spore strips were run at each temperature range.
(2) SteriTec sterilization indicator strips catalog numbers C1 102 and CI 111 were subjected to a steam sterifization cycles at 132°C for the following times: 3 min, 3½ min, 2½ min, 1 min, 2 min. Approximately 300 strips along with 12 biological spore strips were run at each temperature range.
Interpretation of Results: To make the interpretation as objective as possible a panel of three people sclected by the independent laboratory were used to make the PASS/FAIL determinations. These results are shown in Tables I and 2. Since a fow of the results from the first set of interpreters were considered outside the product specifications another set of three interpreters were hired by Steritor to again make the interpretations of the same indivators described in (1) and (2) above. These interpreters were all nurses who generally have more experience in chemical indicator interpretations. These results are shown in Tables 3 and 4.
Conclusion: Results of performance testing of the SteriTee Cross-Checks Indicator Strips indicate that the submitted product, SteriTec Cross-Checks, performed as specified and in all cases completed a color change unly after the blological spore strips tested at the same time under the same conditions, had expired. The interpretations of the second set of interpreters (Nurses) were more uniform in their determinations of whether or not the indicators passed or failed.
Tables 1, 2, 3, and 4 provide "Additional Performance Testing" data for Cross-Checks CI 102 and CI 111 under various sterilization times and temperatures, interpreted by both the initial panel and nurse interpreters. The tables show Pos (Positive color change), Neg (Negative color change), and Bio +/- (Biological Spore Strip results). These tables present raw counts of strips for 'Pos' and 'Neg' and the number of positive/total biological spore strips for each condition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The predicate product was marketed prior to May 28. 1976
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/3 description: The image shows the number 19 in bold font. The number is next to a black rectangle. The number and rectangle are on a white background.
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Steam Sterilization Indicator Strip FDA S10(k) Application
510(k) SUMMARY
510(k) PREMARKET NOTIFICATION SUMMARY
SUBMITTER:
Image /page/0/Picture/8 description: The image shows the company information for STERITEC PRODUCTS MFG. CO., INC. Their address is 680 Atchison Way - Suite 600, Castle Rock, CO 80104, and their phone number is (303) 660-4201. The establishment registration number is 2028456, and the date is AUGUST 12, 1996.
TOM ROLL Printed name of person required to submit 510(k)
Signature of person required to submit 310(k)
PRESIDENT Title of person submitting 510(k)
The
CROSS-CHECKS Steam Steritzation Indicator Strip Proprietary Name: Common/Usuul Name: Steam Sterilization Indicator Classification Name: Physical/Chemical Sterilization Indicator Classification: Class II
1
P03
K951113 p.29110
SteriTex Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Addlication Revised August 12, 1996 as requested by Reviewer PAGE - 2
510(k) SUMMARY
Identification of Predicate devices:
The SteriTec product is similar in design, composition and function to the:
- . ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam
The predicate product was marketed prior to May 28. 1976
Description of 510(k) submission device.
Intended use:
SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.
Comparison to Predicate device
The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932.
Luboratory resting
Laboratory tests were performed to substantiate and verify that the performance of the submitted Starilled product performed ins described These tests were performed by an independent testing laboratory
The following tests were performed.
Test 1 - Completed Sterilization Cycle
- 3 Minutes (@) 132°C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the center of a steam bier vessel along with a spore strip and sterilized at 132°C. (270°F) for three minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips. The test spore strips from each run and the control spore strip were tested. All of the test spore strips showed a
2
K951113 p.3d/10
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviews PAGE - 3
SIU(k) SUMMARY
complete kill while the control strip showed all survivors. All indicator strips passed this test.
Test 2 - Incomplete Sterilization Cycle
20 Seconds (a), 132 °C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the conter of a steam bier vessel along with a spore strip and sterilized at 132 °C (270°F) for only 20 seconds, to simulate improper sterilization conditions. Results: All indicator strips showed incomplete color change (none turned to black), indicating improper sterilization conditions and proper functioning of the strips. The test spore strips for each run and the control spore strip were tested. All of the test spore strips and the control strip showed all survivors. All indicator strips passed this test.
Test 3 - Performance Data for Storage of Cross-Check Strips
-
A. Cross-Checks Strips stored under normal conditions SteriTec CROSS CHECKS sterilization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10 ~38°C (50-100°F) and humidity
Results: The strips were examined for correct indicator color (white). All strips appeared unchanged by the storage process. -
મ . Cross-Checks Strips stored under normal conditions than sterilized. Sterilier CROSS-CHECKS sterifization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10°-38°C (50-100°F) and himidity. The indicator strips were placed in the center of a gravity steam sterilizer and sterilized at 121 "( (250°F) for fifteen minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by normal storage. -
ে. Cross-Checks Strips subjected to extreme tomperature.
SteriTec CROSS-CHECKS sterifization indicator strips were stored in a constant temperature chamber at 578 C. (134" F.) for eight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed and examined The color of the strip had NOT changed from its original normal white color.
3
K951113 p.4.
SteriTec Products Mfg. Co,, Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 4
510(k) SUMMARY
-
D. Cross-Checks Strips subjected to extreme temperature then sterilized. Cross-Check strips were stored in a constant temperature chamber at 57° C. (134" F.) for eight (8) days. Strips were placed in the conter of a gravity steam sterilizer and sterilized at 121 °C (250 "F) for fifteen minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance cansed by storage in extreme heat conditions. -
E. Cross-Checks Strips subjected to extreme humidity. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jai was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days.
Results: Following storage the strips were removed and examined. The color of the strip had NOT changed from its original normal white color. -
F. Cross-Checks Strips subjected to extreme humidity then sterilized. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The hell jar was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days. The indicator strips were placed in the center of a gravity steam sterilized and sterilized at 121 "C (250"F) for fillecn minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme humidity conditions. -
Cross-Checks Strips subjected to extreme temperature and humidity. G. SteriTec Cross-Check sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° F.) for cight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed und examined. The
4
2
POS
K95///3
p.5df
Sterilice Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 5
510ik) SUMMARY
- color of the strip had changed from its original white color to a light tan. 11. Cross-Checks Strips subjected to extreme temperature and humidity then sterilized.
SteriTec Cross-Check sterilization indicator stored in a vacuum desiceator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° I'.) for eight (8) days Results: Following the fifteen minute sterilization cycle, the test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme heat and humidity conditions.
Test 4 - Performance Data for Cross-Checks Strips sterilized at various sterilization temperatures and sterilization times
- SteriTec Cross-Checks sterilization indicator strips catalog (1) numbers CI 102 and CI 111 were subjected to a steam sterilization eveles for 3 minutes at the following sterilization temperatures: 124 "C 130°C 132°C 134°C. 128°C Approximately 300 strips along with 12 hiological spore strips were run at each temperature range.
- SteriTec sterilization indicator strips catalog numbers C1 102 and (2) CI 111 were subjected to a steam sterifization cycles at 132°C for the following times:
3 min 3% min 2% min 1 min 2 min Approximately 300 strips along with 12 biological spore strips were run at each temperature range.
Interpretation of Results:
To make the interpretation as objective as possible a panel of three people sclected by the independent laboratory were used to make the PASS/FAIL determinations. These results are shown in Tables I and 2. Since a fow of the results from the first set of interpreters were considered outside the product specifications another set of three interpreters were hired by Steritor to again make the interpretations of the same indivators described in (1) and (2) above. These interpreters were all nurses who generally have more experience in chemical indicator interpretations. These results are shown in Tables 3 and 4.
Conclusion:
Regults of performance testing of the SteriTee Cross-Checks Indicator Strips indicate that the submitted product, SteriTec Cross-Checks, performed as
5
Image /page/5/Picture/2 description: The image contains handwritten text. The text on the top left reads 'K951113'. On the top right, the text reads 'P02'. The text on the bottom reads 'p6y10'.
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 6
510(k) SUMMARY
specified and in all cases completed a color change unly after the blological spore strips tested at the same time under the same conditions, had expired. The interpretations of the second set of interpreters (Nurses) were more uniform in their determinations of whether or not the indicators passed or failed.
6
| Steritec Products Mfg. Co., Inc. |
|---|
| CROSS-CHECKS Chemical Sterilization Indicator |
| FDA 510(k) Application |
| Revised August 12, 1996 as requested by Reviewer |
| PAGE - 7 |
8YWMΩS (1)015
| TABLE 1 | ||||||
|---|---|---|---|---|---|---|
| Additional Performance Testing-Cross-Checks CI 102 | ||||||
| 3 Minutes Sterilization Time at: | ||||||
| 124°C | 128°C | 130°C | 132°C | 134°C | ||
| Pos | ||||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | ||||||
| 0 | ||||||
| 275 | ||||||
| 12/12 | 0 | |||||
| 300 | ||||||
| 1/12 | 108 | |||||
| 183 | ||||||
| 0/12 | 342 | |||||
| 92 | ||||||
| 0/12 | 292 | |||||
| 0 | ||||||
| 0/12 | ||||||
| 132°C for: | ||||||
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minutes | ||
| Pos | ||||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| -:- | Pos | |||||
| Neg | ||||||
| Bio | ||||||
| +/- | ||||||
| 0 | ||||||
| 292 | ||||||
| 9/12 | 17 | |||||
| 275 | ||||||
| 0/12 | 142 | |||||
| 150 | ||||||
| 0/12 | 342 | |||||
| 92 | ||||||
| 0/12 | 292 | |||||
| 0 | ||||||
| 0/12 | ||||||
| TABLE 1 |
ARBITATI
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1788187877
| Additional Performance Testing -Cross-Checks CI 111 | |||||
|---|---|---|---|---|---|
| 124°C | 128°C | 130°C | 132°C | 134°C | |
| 3 Minutes Sterilization Time at: | |||||
| Pos | 0 | 0 | 292 | 233 | 292 |
| Neg | 300 | 300 | 0 | 217 | 0 |
| Bio | |||||
| +/- | 12/12 | 9/12 | 1/12 | 0/12 | 0/12 |
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minutes | |
| 132°C for: | |||||
| Pos | 0 | 0 | 283 | 192 | 233 |
| Neg | 300 | 0 | 0/12 | 108 | 0/12 |
| Bio | |||||
| +/- | 9/12 | 0/12 | 0 | 0/12 | 0/12 |
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| Additional Performance Testing-Cross-Checks CI 102(Nurse Interpreters) | |||||
|---|---|---|---|---|---|
| 3 Minutes Sterilization Time at: | |||||
| 124°C | 128°C | 130°C | 132°C | 134°C | |
| Pos | Neg | Bio | |||
| +/- | Pos | Neg | Bio | ||
| +/- | |||||
| 0 | 275 | 12/12 | 300 | 1/12 | 92 |
| Pos | Neg | Bio | |||
| +/- | Pos | Neg | Bio | ||
| +/- | |||||
| 200 | 0/12 | 400 | 50 | 0/12 | 300 |
| 1 minute | 2 minutes | 2 ½ minutes | |||
| 132°C for: | |||||
| 3 minutes | 3 ½ minutes | ||||
| Pos | Neg | Bio | |||
| +/- | Pos | Neg | Bio | ||
| +/- | |||||
| 0 | 300 | 9/12 | 300 | 0/12 | 133 |
| Pos | Neg | Bio | |||
| +/- | Pos | Neg | Bio | ||
| +/- | |||||
| 167 | 0/12 | 400 | 50 | 0/12 | 300 |
| Pos | Neg | Bio | |||
| +/- | |||||
| 0 | 0/12 |
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| Additional Performance Testing-Cross-Checks CI 111(Nurse Interpreters)
| 3 Minutes Sterilization Time at: | |||||
|---|---|---|---|---|---|
| 124°C | 128°C | 130°C | 132°C | 134°C | |
| Pos | Pos | Pos | Pos | Pos | |
| Neg | Neg | Neg | Neg | Neg | |
| Bio | |||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | |||||
| 0 | |||||
| 275 | |||||
| 12/12 | 0 | ||||
| 292 | |||||
| 1/12 | 50 | ||||
| 250 | |||||
| 0/12 | 458 | ||||
| 8 | |||||
| 0/12 | 300 | ||||
| 0 | |||||
| 0 | |||||
| 132°C for: | |||||
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minute | |
| Pos | Pos | Pos | Pos | Pos | |
| Neg | Neg | Neg | Neg | Neg | |
| Bio | |||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | Bio | ||||
| +/- | |||||
| 0 | |||||
| 275 | |||||
| 9/12 | 0 | ||||
| 283 | |||||
| 0/12 | 142 | ||||
| 150 | |||||
| 0/12 | 458 | ||||
| 8 | |||||
| 0/12 | 292 | ||||
| 0 | |||||
| 0 |
ל בתחתונה ב
: saj ● N SA9) ในระบ ระบับเซตรี=809
(IA){) ກັນຂອງ ຈາກ່າສົງຈັດລົງຈ
- SYNOPSIS
- DESCRIPTION
- 10 dio