Machine readable sterilization indicator for monitoring articles to be sterilized
First Claim
Patent Images
1. A sterilization indicator for monitoring the effectiveness of a sterilization process, the sterilization indicator being capable of being read by a code reader, the sterilization indicator comprising:
- (a) a substrate having a surface, (b) sterilizing agent sensitive means for responding to a sterilization process, said sterilizing agent sensitive means being associated with said surface of said substrate, said sterilizing agent sensitive means being arranged in at least a portion of a readable code to provide;
(i) a first indication to the code reader prior to the sterilization indicator being exposed to a sterilization process, and (ii) a second indication to the code reader after the sterilization indicator is exposed to at least a portion of the sterilization process, and wherein the first indication is different than said second indication.
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Abstract
A sterilization indicator having sterilizing agent sensitive indicia is described. The indicator allows a sterilization cycle to be monitored without the need for a user to subjectively distinguish between color, quality or intensity of display patterns.
188 Citations
32 Claims
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1. A sterilization indicator for monitoring the effectiveness of a sterilization process, the sterilization indicator being capable of being read by a code reader, the sterilization indicator comprising:
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(a) a substrate having a surface, (b) sterilizing agent sensitive means for responding to a sterilization process, said sterilizing agent sensitive means being associated with said surface of said substrate, said sterilizing agent sensitive means being arranged in at least a portion of a readable code to provide;
(i) a first indication to the code reader prior to the sterilization indicator being exposed to a sterilization process, and (ii) a second indication to the code reader after the sterilization indicator is exposed to at least a portion of the sterilization process, andwherein the first indication is different than said second indication. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
a) after exposure to a previously stabilized condition of dry heat at 140 degrees Celsius (plus or minus two degrees Celsius) for 30 minutes (plus or minus one minute), the sterilization indicator shows either no change or a change that is markedly different from the change occurring after exposure to the steam sterilization process; and
b) the second indication shall not occur until the sterilization indicator has been exposed to saturated steam for not less than 2 minutes at 121 degrees Celsius (+3/−
0 degrees Celsius); and
c) the second indication shall occur after the sterilization indicator is subjected to saturated steam for not more than 10 minutes at 121 degrees Celsius (+3/−
0 degrees Celsius).
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15. A sterilization indicator according to claim 1 wherein said sterilizing agent sensitive means is adapted for use in a predetermined steam sterilization process and is selected so that the sterilization indicator satisfies the 134 degree Celsius test defined in Section 6.1 of Sterilization of Health Care Products—
- Chemical Indicators—
Part 1;
General Requirements, ANSI/AAMI ST 60—
(1996) (referencing the test methods described in ANSI/AAMI ST 45—
1992, Bier/Steam vessels) in that;a) after exposure to a previously stabilized condition of dry heat at 140 degrees Celsius (plus or minus two degrees Celsius) for 30 minutes (plus or minus one minute), the sterilization indicator shows either no change or a change that is markedly different from the change occurring after exposure to the steam sterilization process; and
b) the second indication shall not occur until the sterilization indicator has been exposed to saturated steam for not less than 20 seconds at 134 degrees Celsius (+3/−
0 degrees Celsius); and
c) the second indication shall occur after the sterilization indicator is subjected to saturated steam for not more than 2 minutes at 134 degrees Celsius (+3/−
0 degrees Celsius).
- Chemical Indicators—
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16. A sterilization indicator according to claim 1 wherein said sterilizing agent sensitive means is selected so that the sterilization indicator reacts to all critical parameters over a specific range of a predetermined sterilization process.
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17. A sterilization indicator according to claim 16 wherein the predetermined sterilization process is a steam sterilization process and the critical parameters are time, temperature and saturated steam.
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18. A sterilization indicator according to claim 16 wherein the predetermined sterilization process is an ethylene oxide sterilization process and the critical parameters are time, temperature, humidity and ethylene oxide concentration.
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19. A sterilization indicator according to claim 1 wherein the first indication is null indication.
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20. A sterilization indicator according to claim 16 wherein the predetermined sterilization process is a liquid peracetic acid sterilization process.
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21. A sterilization indicator according to claim 16 wherein the predetermined sterilization process is a hydrogen peroxide sterilization process.
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22. A sterilization indicator according to claim 21 wherein the sterilization process is a vapor phase hydrogen peroxide process.
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23. A sterilization indicator according to claim 22 wherein the sterilization process includes a plasma phase.
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24. A sterilization indicator according to claim 1 wherein the sterilization indicator comprises indicator tape.
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25. A sterilization indicator according to claim 1 wherein the sterilization indicator comprises a label.
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26. A sterilization indicator according to claim 1 wherein said sterilizing agent sensitive means is adapted for use in a predetermined steam sterilization process and is selected so that the sterilization indicator satisfies the 134 degree Celsius test defined in Section 6.1 of Sterilization of Health Care Products—
- Chemical Indicators—
Part 1;
General Requirements, ANSI/AAMI ST 60—
(1996) (referencing the test methods described in ANSI/AAMI ST 45—
1992, Bier/Steam vessels) in that;a) the second indication shall not occur until the sterilization indicator has been exposed to saturated steam for not less than 20 seconds at 134 degrees Celsius (+3/−
0 degrees Celsius); and
b) the second indication shall occur after the sterilization indicator is subjected to saturated steam for not more than 2 minutes at 134 degrees Celsius (+3/−
0 degrees Celsius).
- Chemical Indicators—
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27. A chemical indicator for monitoring the effectiveness of a sterilization process, the sterilization indicator being capable of being read by a code reader, the chemical indicator comprising:
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a substrate having a surface, sterilizing agent sensitive ink sized and shaped in at least a portion of a bar code, said sterilizing agent sensitive ink being adapted provide a first indication to the code reader prior to the sterilization indicator being exposed to a sterilization process, and a second indication to the code reader after the sterilization indicator is exposed to at least a portion of the sterilization process, and wherein the first indication is different than said second indication. - View Dependent Claims (28)
a) after exposure to a previously stabilized condition of dry heat at 140 degrees Celsius (plus or minus two degrees Celsius) for 30 minutes (plus or minus one minute), the sterilization indicator shows either no change or a change that is markedly different from the change occurring after exposure to the steam sterilization process; and
b) the second indication shall not occur until the sterilization indicator has been exposed to saturated steam for not less than 20 seconds at 134 degrees Celsius (+3/−
0 degrees Celsius); and
c) the second indication shall occur after the sterilization indicator is subjected to saturated steam for not more than 2 minutes at 134 degrees Celsius (+3/−
0 degrees Celsius).
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29. A chemical indicator for monitoring the effectiveness of a sterilization process, the chemical indicator comprising:
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a substrate having a surface, sterilizing agent sensitive ink sized and shaped in a bar code, said bar code having a first color prior to the sterilization indicator being exposed to a sterilization process, and a second color after the sterilization indicator is exposed to at least a portion of the sterilization process, and wherein the first color is different than said second color. - View Dependent Claims (30, 31, 32)
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Specification