Technical Data Monograph. VERIFY Assert Self-Contained Biological Indicators and VERIFY Assert STEAM Process Challenge Devices

Transcription

1 Technical Data Monograph VERIFY Assert Self-Contained Biological Indicators and VERIFY Assert STEAM Process Challenge Devices

2 Table of Contents 1. Introduction Product Use Application...4 Device Description...5 Interpretation of Chemical Indicators...6 Regulatory Status Technological Review of Early Detection System Biological Indicator Performance Confirmation of compliance with population and resistance performance specifications Compliance to ANSI/AAMI/ISO :2014 Type 5 Integrating Indicator Chemical Indicator Performance Guidance...11 Type 5 integrating indicator Pass and Fail Condition confirmation in saturated steam conditions...11 Confirmation of Stated Value...11 Confirmation of Fail Condition...12 Dry Heat Performance...12 Temperature Coefficient Testing...12 Offsetting/Bleed Testing VERIFY Assert STEAM Process Challenge Devices Test Summary VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles...13 VERIFY Assert STEAM Process Challenge Device for Gravity Cycles Environmental Considerations References

3 1Introduction This Technical Data Monograph illustrates the principles of operation and the performance of the VERIFY Assert Self-Contained Biological Indicators (SCBI) and VERIFY Assert STEAM Process Challenge Devices. Steam Sterility Assurance Monitoring The most common sterilization process utilized in health care facilities for the terminal sterilization of reusable medical devices is moist heat sterilization. Moist heat sterilization, also called steam sterilization, utilizes vaporized steam under high pressures to create lethal conditions within a steam sterilizer. To monitor and confirm the lethality of a sterilization process, several trade organizations and governmental agencies have developed recommended practices when utilizing steam sterilization to sterilize medical devices in healthcare. The most referenced recommendations are published by the Association for the Advancement of Medical Instrumentation (AAMI), the Association for peri-operative Registered Nurses (AORN) and the Centers for Disease Control (CDC). Though the recommendations may differ slightly, all agree that in addition to physical and chemical monitoring devices, steam sterilization processes must be routinely assessed using an appropriate biological challenge. Biological indicators (BI) and process challenge devices (PCD) are utilized to confirm the ability of steam sterilizers to kill large populations of highly resistant bacterial spores. The CDC guidance for Infection Control states that spores used in BIs are more resistant and present in greater numbers than are the common microbial contaminants found on patient care equipment, the demonstration that the biological indicator has been inactivated strongly implies that other potential pathogens in the load have also been killed. All three organizations recommend weekly, preferably daily, verification of the steam sterilization process. Additionally, a biological indicator should be placed in a challenge pack that provides a challenge equivalent to that of a device that would be processed within the load. ANSI/AAMI ST79, Comprehensive guide to steam sterilizers and sterility assurance in health care facilities, provides detailed instructions on the materials and construction of the biological indicator test pack to be used when monitoring steam sterilization processes. In addition to routine monitoring of the sterilizer s performance, biological indicators and challenge packs should be used for monitoring sterilization loads which have an implantable device. The load containing the implantable device is quarantined while awaiting the results of the biological indicator. ANSI/AAMI ST79 also identifies the need to perform qualification testing of the steam sterilizer when it is first installed, relocated and whenever a major repair has been completed. The VERIFY Assert SCBI and VERIFY Assert STEAM Process Challenge Devices have been designed to meet the requirements of these organizations for routine monitoring, load monitoring and qualification of steam sterilization processes for which they are labeled. 3

4 2Product Use Application: The VERIFY Assert Self Contained Biological Indicators are self-contained biological indicators designed to be used with standard steam sterilization cycles (See Table 1) for routine monitoring, product testing and qualification of steam sterilization processes. When used in conjunction with the VERIFY Incubator for Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes. The VERIFY Assert STEAM Process Challenge Devices for Dynamic Air Removal and Gravity Cycles are disposable biological test packs designed to be used with standard steam sterilization cycles (See Table 1) for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The VERIFY Incubator for Assert SCBI is designed for exclusive use with the VERIFY Assert SCBI and VERIFY Assert STEAM Process Challenge Devices. The incubator is used to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 C for a fluorescent result within 40 minutes. 4

5 Device Description: The VERIFY Assert Self Contained Biological Indicators are self-contained biological indicators consisting of a high population of Geobacillus stearothermophilus spores and defined media. A two-ply label allows removal of the top label for application of the lot and expiration date of the SCBI to paper documentation system. The bottom label is imprinted with a process indicator for steam as defined by ANSI/AAMI/ISO The defined media is held within the cap using a laminated foil. The twist cap design provides a smooth one step process to release the media from the cap and seal the SCBI from contamination. A simple flick of the wrist releases the media from the cap to the base of the vial. The SCBI is intended to be incubated and final results read by the VERIFY Incubator for Assert SCBI within 40 minutes. The VERIFY Assert STEAM Process Challenge Devices (PCD) are disposable biological indicator test packs containing a VERIFY Assert SCBI and an integrating indicator. The VERIFY Assert STEAM PCD for Dynamic Air Removal Cycles includes a Type 5 chemical integrator that meets ANSI/AAMI/ISO :2014 requirements for Type 5 integrating indicators. The VERIFY Assert STEAM PCD for Gravity Cycles includes a chemical integrator that meets FDA requirements for chemical integrators. The VERIFY Assert STEAM Process Challenge Devices (PCD) are designed with a transparent plastic housing sealed with a laminate foil. The VERIFY Assert SCBI and the chemical integrator are placed within this housing. The transparent housing allows immediate visibility of the integrator s results prior to opening the PCD. The expiration date is encoded in the lot number imprinted on the PCD. 5

6 The PCD design includes a small channel which acts as a tortuous pathway for steam to reach the biological indicator and chemical integrator housed within the PCD. Both the plastic housing and laminated foil are impermeable to the steam and the narrow channel is the only pathway for air removal and steam penetration, making this design an appropriate challenge to the steam sterilization process. The VERIFY Incubator for Assert SCBI is a compact, tabletop incubator that functions at C. It consists of two independent heating blocks, each containing four numbered wells for incubation of processed or control VERIFY Assert SCBIs. Each well is designed to fit the specific shape of the VERIFY Assert SCBI. An LCD screen provides prompts, test results or error messages that might occur during operation. Test results may be downloaded from the incubator to an optional printer. Interpretation of Chemical Indicators Interpretation of steam process indicator on SCBI: The process indicator for steam is located on the bottom label of the SCBI. This process indicator is a Type 1 process indicator as defined by ANSI/AAMI/ISO :2014. The indicator will start pink and change to brown following exposure to steam. Unexposed Pass 6

7 Interpretation of Type 5 integrating indicator used in the VERIFY Assert STEAM PCD for Dynamic Air Removal Cycles: The Type 5 integrating indicator used within the VERIFY Assert STEAM PCD for Dynamic Air Removal Cycles is a moving front indicator that is designed with a pellet which, when exposed to all the critical parameters of sterilization, will melt and its dye will migrate across the window. The integrator demonstrates passing results when the dark bar has completely traveled to within the ACCEPT area of the window. VERIFY Dark bar must STEAM enter blue Integrating Indicator 5CM i5 accept area 1 1 VERIFY STEAM Integrating Indicator 5CM i5 1 REJECT (NO) XXX.XXXX-XX-XX VERIFY STEAM Integrating Indicator 5CM i5 REJECT (NO) XXX.XXXX-XX-XX REJECT (NO) XXX.XXXX-XX-XX ACCEPT (OK) Dark bar must enter blue accept area ACCEPT (OK) Dark bar must enter blue accept area ACCEPT (OK) UNPROCESSED PASS FAIL Interpretation of integrating indicator used in the VERIFY Assert STEAM PCD for Gravity Cycles: When exposed to all the critical parameters of sterilization, this integrating indicator will demonstrate a color change from yellow to blue/purple. The indicator is considered passing when the starting yellow color has completely changed to blue/purple. COLOR REFERENCE GUIDE BEFORE USE FAIL PASS FAIL Colors are an approximation Regulatory Status: The VERIFY Assert Self-Contained Biological Indicators and VERIFY Assert STEAM Process Challenge Devices have been cleared for release into interstate commerce as Type II Medical Devices as defined by the US Food and Drug Administration. See Table 1 for pertinent 510(k) premarket notification numbers. 7

8 Table (k) Matrix for VERIFY Assert SCBI, VERIFY Assert STEAM PCD and VERIFY Incubator for Assert SCBI Reorder Number LCB031 Description Sterilization Cycles 510(k) Number VERIFY Assert Self Contained Biological Indicator 270 F/132 C 4 minute Prevacuum Steam 270 F/132 C 4 minute Steam-Flush Pressure-Pulse Steam (SFPP) 275 F/135 C 3 minute Prevacuum Steam 275 F/135 C 3 minute SFPP Steam 250 F/121 C 30 minute Gravity Steam 270 F/132 C 15 minute Gravity Steam K LCB032 LCB033 VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles 270 F/132 C 4 minute Prevacuum Steam 270 F/132 C 4 minute SFPP Steam 275 F/135 C 3 minute Prevacuum Steam 275 F/135 C 3 minute SFPP Steam K LCB043 VERIFY Assert STEAM Process Challenge Device for Gravity Cycles 250 F/121 C 30 minute Gravity Steam Sterilization 270 F/132 C 15 minute Gravity Steam K LCB030 VERIFY Incubator for Assert SCBI Not applicable K

9 3Technological Review of Early Detection System The VERIFY Assert SCBI has been designed to allow confirmation of negative growth within 40 minutes of incubation in conjunction with the dedicated VERIFY Incubator that has been developed specifically for use with the VERIFY Assert SCBIs. The VERIFY Assert SCBI utilizes spores of Geobacillus stearothermophilus. Following sterilization, the SCBI is activated and incubated using the VERIFY Incubator. Any viable spores present will begin to germinate upon contact with the defined media containing the fluorescent substrate 4-methylumbelliferyl-α-D-glucopyranoside(MUD). The enzyme α-glucosidase reacts with the MUD, to produce a fluorescent signal. A general schematic of the reaction between α-glucosidase and its substrate is illustrated in Figure 1. 4-methylumbelliferyl-α-Dglucopyranoside (MUD) α-d-glucosidase glucose 4-methylumbelliferone fluorescence Figure 1: General reaction schematic of the α- glucosidase activity on the substrate MUD If the SCBI was properly sterilized, no viable Geobacillus stearothermophilus spores are present in the SCBI, and therefore no increase in fluorescence. A positive growth response read by the VERIFY Incubator for Assert SCBI results from the presence of α-glucosidase, indicating inappropriate sterilization of the SCBI. The fluorescent signal that is generated from the reaction between α-glucosidase and MUD is read by the VERIFY Incubator for Assert SCBI. Each well of the VERIFY Incubator for Assert SCBI has its own individual LED and detector to monitor the potential fluorescence generated as a result of the reaction with α-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user either by audible and visual means for a growth response or by visual means only for a no growth result. Please refer to the Operator s Manual for the VERIFY Incubator for Assert SCBI for more detail and operation instructions. 9

10 4Biological Indicator Performance The VERIFY Assert SCBI is a biological indicator with an enzyme-based early-readout detection system. The performance of the VERIFY Assert SCBI was tested using methods defined in per ANSI/AAMI/ISO :2006 Sterilization of health care products Biological Indicators Part 1: General Requirements and ANSI/AMI/ISO :2006 Sterilization of health care products Biological Indicators Part 3: Biological indicators for moist heat sterilization processes. The SCBI s population and resistance information is provided with each box of product. ANSI/AAMI/ISO :2006 and :2006 specify requirements for biological indicators designed to monitor moist heat sterilization processes. Table 2 lists a few of those requirements. Table 2. Performance requirements for biological indicators intended for moist heat sterilization as identified by ANSI/AAMI/ISO and Specifications VERIFY Assert SCBI Specifications Indicator organism: Geobacillus stearothermophilus Geobacillus stearothermophilus Spore population 1.0 x 10 5 cfu/scbi 1.0 x 10 6 to 4.0 x 10 6 cfu/scbi D-value at 121 C (250 F) 1.5 minutes Z value 6 C Note: US FDA requires Z value 10 C D-value at 121 C (250 F) is 1.5 minutes Z value is 10 C Confirmation of compliance with population and resistance performance specifications Test Objective: To confirm compliance with the population and resistance performance of the SCBI. Test Method: Three lots of VERIFY Assert SCBIs were tested for population of viable spores and resistance within a steam resistometer. D-values were determined at 121 C, 132 C, and 135 C using Holcomb-Spearman-Karver D-value calculations. Z-value calculations were based on the slope of the curve generated from the D-values. Resistance was then confirmed using the Survival/Kill calculation: Survival time = not less than (log10 nominal population -2) x D-value Kill time = not more than (log10 nominal population + 4) x D-value Test Articles: 3 lots of VERIFY Assert SCBIs Test Results: Population and resistance test results are presented in Table 3. Survival/Kill testing was confirmed for all 3 lots evaluated and are presented in Table 4. Table 3. Confirmation of population and resistance profiles for 3 lots of VERIFY Assert SCBIs 10 Lot Population 1121 C D-value 132 C D-value 135 C D-value Z-value x x x

11 Table 4. Confirmation of Survival and Kill Times for 3 lots of VERIFY Assert SCBIs Lot Survival Exposure time Test Results (#positive/#tested) Kill Exposure time Test Results (#positive/#tested) / / / / / /50 5Compliance to ANSI/AAMI/ISO :2014 Type 5 Integrating Indicator Chemical Indicator Performance Guidance Integrating indicators are designed to react to all the critical parameters of sterilization. The SVs (stated values) are generated to be equivalent to or exceed the performance of biological indicators. The integrating indicators within the VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles were tested to demonstrate performance to Type 5 integrating indicator standards. This included: Type 5 integrating indicator standards according to ANSI/AAMI/ISO :2014 using a steam resistometer meeting requirements specified in ANSI/AAMI/ISO 18472:2006. Dry heat test requirements according to ANSI/AAMI/ISO :2014. Type 5 integrating indicator Pass and Fail condition confirmation in saturated steam conditions Confirmation of Stated Value (SV) Test Objective: To demonstrate that the indicators show a passing result (reach endpoint) at the minimum SV for the integrating indicator meeting the requirements of Type 5 integrating indicators as defined in ANSI/AAMI/ISO :2014. Test Method: Three lots of indicators were tested to determine the SV at 121 C, 128 C, 132 C, and 135 C within a steam resistometer. Indicators were tested independent of the Process Challenge Device (PCD) Acceptance Criteria: A SV of 16.5 at 121 C and 1.2 at 135 C. 128 C and 132 C do not have a minimum SV requirement per ANSI/AAMI/ISO Test Results: As presented in Table 5, all integrating indicators met the acceptance criteria. Table 5. Confirmation of Integrator Stated Value Exposure Temperature ( C) Exposure Time (min) Results #Pass/#Tested 1Lot 1 Lot 2 Lot 3 BI Results /9 9/9 9/9 3/ /9 9/9 9/9 3/ /9 9/9 9/9 3/ /9 9/9 9/9 3/3 Acceptance Criteria Met YES YES YES YES 11

12 Confirmation of Fail Condition Test Objective: To demonstrate that the indicators fail at the SV with conditions of -15% time and -1 C for the integrating indicator meeting the requirements of Type 5 integrating indicators as defined in ANSI/AAMI/ISO Test Method: Three lots of indicators were tested to evaluate a fail condition at 121 C, 128 C, 132 C, and 135 C within a steam resistometer. Indicators were tested independent of the Process Challenge Device (PCD) Acceptance Criteria: A fail result at -15% time and -1 C for each SV. Test Results: As presented in Table 6, all integrating indicators met the acceptance criteria. Table 6. Confirmation of Fail Conditions for Chemical Integrator Exposure Temperature ( C) Exposure Time (min) Results #Pass/#Tested 1Lot 1 Lot 2 Lot 3 BI Results /9 0/9 0/9 3/ /9 0/9 0/9 3/ /9 0/9 0/9 3/ /9 0/9 0/9 3/3 Acceptance Criteria Met YES YES YES YES Dry Heat Performance Test Objective: To demonstrate that the indicators do not reach their end point when exposed to dry heat at 140 ± 2 C for 30 ± 1 min. Test Method: Three lots of indicators were tested to evaluate if endpoint was achieved when held in a dry heat oven. Indicators were tested independent of the Process Challenge Device (PCD) Acceptance Criteria: 100% of indicators tested from three lots shall not reach the end point. Test Results: As presented in Table 7, all integrating indicators met the acceptance criteria. Table 7. Confirmation of Fail Conditions for Chemical Integrator Exposure Temperature ( C) Exposure Time (min) Results #Pass/#Tested 1Lot 1 Lot 2 Lot /9 0/9 0/9 Acceptance Criteria Met YES YES YES Temperature Coefficient Testing Test Objective: To demonstrate that the indicators have a temperature coefficient of not less than 10 C and not more than 27 C with a correlation coefficient of not less than 0.9. Test Method: Plot log SV vs. temperature. Acceptance Criteria: All lots have a temperature coefficient of 10 C and 27 C with a correlation coefficient of not less than 0.9. Test Results: As presented in Table 8, all integrating indicators met the acceptance criteria. 12

13 Table 8. Temperature Coefficient Results for Chemical Integrator Lot Temperature Coefficient Correlation Coefficient Acceptance Criteria Met YES YES YES Offsetting/Bleed Testing Test Objective: To demonstrate that the indicators shall not offset or bleed, penetrate the substrate to which it s applied or materials in which it is in contact. Test Method: Indicators are processed in a steam sterilizer at 135 C and observed for transference of materials that are placed in intimate contact with the indicator. Acceptance Criteria: No transference onto plain material from the indicator ink or text ink shall occur. Test Results: As presented in Table 9, all integrating indicators met the acceptance criteria. Table 9. Temperature Coefficient Results for Chemical Integrator Lot Exposure Time (min) Result #offsetting/#tested Acceptance Criteria Met 1 3 0/3 YES 2 3 0/3 YES 3 3 0/3 YES 6VERIFY Assert STEAM Process Challenge Devices Test Summary VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles - LCB032/ LCB033 The performance of the VERIFY Assert STEAM PCD is equivalent to the biological indicator 16-towel test pack as defined in ANSI/ AAMI ST79. Table 10 compares the performance of the VERIFY Assert STEAM PCD for Dynamic Air Removal Cycles against that of the ANSI/AAMI ST79: towel biological indicator test pack. Test Objective: To demonstrate that the PCD for dynamic air removal is as resistant as the 16-towel biological indicator test pack as defined in ANSI/AAMI ST79:2012. Test Method: Three lots of PCDs and SCBIs in the 16-towel pack were tested in defined exposure conditions using a steam sterilizer. Acceptance Criteria: The performance of the SCBI in the PCD is as resistant as the SCBI in the 16-towel pack. Test Results: As presented in Table 10, the SCBIs showed comparable resistance in either the 16-towel pack or the PCD 13

14 Table 10. Comparison of VERIFY Assert STEAM Process Challenge Devices to the standard ANSI/AAMI ST79 16-towel biological indicator test pack Exposure Conditions Integrator # Fail 16-Towel Test Pack* #positive/#tested SCBI Fluorescence SCBI Growth Integrator Process Challenge Device* #positive/#tested SCBI Fluorescence SCBI Growth Aborted Cycle 132 C Prevac 18/18 18/18 18/18 72/72 72/72 72/ C Prevac 18/18 18/18 18/18 72/72 72/72 72/ C SFPP 18/18 18/18 18/18 72/72 72/72 72/ C SFPP 18/18 18/18 17/17 72/72 72/72 72/72 Full Cycle 132 C Prevac 4 minutes 0/18 0/18 0/18 0/72 0/72 0/ C Prevac 3 minutes 0/21 0/21 0/21 0/74 0/72 0/ C SFPP 4 minutes 0/21 0/21 0/21 0/73 0/72 0/ C SFPP 3 minutes 0/21 0/21 0/21 0/74 0/72 0/72 *Results are combined for three lots of test articles The performance of the VERIFY Assert STEAM PCD is more resistant than the SCBI external to the PCD. Table 11 compares the performance of the VERIFY Assert STEAM PCD for Dynamic Air Removal Cycles against that of an SCBI external to the PCD. Test Objective: To demonstrate that the PCD for dynamic air removal is more resistant than a VERIFY Assert SCBI external to the PCD. Test Method: Three lots of PCDs and external SCBIs were tested in defined exposure conditions using a steam sterilizer. Acceptance Criteria: The PCD is more resistant than an external SCBI. Test Results: As presented in Table 11, the PCDs showed greater resistance than an external SCBI. Table 11. Comparison of VERIFY Assert STEAM Process Challenge Devices to an External SCBI Exposure Conditions Process Challenge Device* (#grow/#tested) External SCBI* (#grow/#tested) C Prevac 18/18 0/ C Prevac 18/18 0/18 *Results are combined for three lots of test articles VERIFY Assert STEAM Process Challenge Device for Gravity Cycles - LCB043 The performance of the VERIFY Assert STEAM PCD is equivalent to the biological indicator 16-towel test pack as defined in ANSI/ AAMI ST79:2012. Table 12 compares the performance of the VERIFY Assert STEAM PCD for Gravity Cycles against that of the ANSI/AAMI ST79 16-towel biological indicator test pack when exposed to two common gravity steam sterilization cycles. Test Objective: To demonstrate that the PCD for gravity cycles is as resistant as the 16-towel biological indicator test pack as defined in ANSI/AAMI ST79:2012. Test Method: Three lots of PCDs and SCBIs in the 16-towel pack were tested in defined exposure conditions using a steam sterilizer.

15 Acceptance Criteria: The performance of the SCBI in the PCD is as resistant as the SCBI in the 16-towel pack. Test Results: As presented in Table 12, the SCBIs showed comparable resistance in either the 16-towel pack or the PCD. Table 12. Comparison of VERIFY Assert STEAM Process Challenge Devices for Gravity Cycles to the ANSI/AAMI ST79 16-towel biological indicator test pack Exposure Conditions Integrator # Fail 16-Towel Test Pack* #positive/#tested SCBI Fluorescence SCBI Growth Aborted Cycle Integrator Process Challenge Device* #positive/#tested SCBI Fluorescence SCBI Growth 121 C Gravity 18/18 18/18 18/18 73/73 72/72 72/ C Gravity 18/18 18/18 18/18 72/72 72/72 72/72 Full Cycle 121 C Gravity 30 minutes 0/18 0/18 0/18 0/72 0/72 0/ C Gravity 15 minutes 0/18 0/18 0/18 0/72 0/72 0/72 *Results are combined for three lots of test articles The performance of the VERIFY Assert STEAM PCD is more resistant than the SCBI external to the PCD. Table 13 compares the performance of the VERIFY Assert STEAM PCD for Gravity Cycles against that of an SCBI external to the PCD. Test Objective: To demonstrate that the PCD for gravity cycles is more resistant than a VERIFY Assert SCBI external to the PCD. Test Method: Three lots of PCDs and external SCBIs were tested in defined exposure conditions using a steam sterilizer. Acceptance Criteria: The PCD is more resistant than an external SCBI. Test Results: As presented in Table 13, the PCD displayed greater resistance than the external SCBI. Table 13. Comparison of VERIFY Assert STEAM Process Challenge Devices to an External SCBI Exposure Conditions Process Challenge Device* (#grow/#tested) External SCBI* (#grow/#tested) 121 C Gravity 18/18 0/ C Gravity 20/20 0/19 *Results are combined for three lots of test articles. 15

16 7Environmental Considerations STERIS Corporation is committed to environmental impact issues. From the design of our products to the way we package them, we consider issues such as recyclability and reduced waste streams. The VERIFY Assert Self Contained Biological Indicator and VERIFY Assert STEAM Process Challenge Device use biodegradable and recyclable SBS board packaging. Cases are composed or recyclable corrugated cardboard. The VERIFY Assert STEAM Process Challenge Device is composed of plastic pack sealed with laminate foil. The plastic pack is constructed using polypropylene. The compact design of the PCD eliminates the waste associated with traditional paper pack style biological indicator test packs. The process indicators and integrating indicators are manufactured in the absence of lead or other heavy metals. The packaging and product components for the PCD and SCBI do not intentionally contain latex or dry natural rubber. 16

17 8References 1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 2. ANSI/AAMI/ISO :2014 Sterilization of health care products - Chemical indicators- Part 1: General Requirement ANSI/AAMI/ISO :2006 Sterilization of health care products - Biological indicators- Part 1: General Requirements. 4. ANSI/AAMI/ISO :2006 Sterilization of health care products - Biological indicators- Part 3: Biological Indicators for moist heat sterilization processes. 17

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