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Condition:
- Weight: 0.21 lb
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Learn more:
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MFR:
Crosstex International
Ships from MFI Medical
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MPN: SSI100
- Phone: (800) 483-7433
Frequently asked questions
Is this integrator compatible with all steam sterilization cycles?
Yes, the Crosstex Steamplus Class 5 Integrator is designed for high versatility and reliable performance across various common steam sterilization methods. It is fully compatible with the following cycle types:<ul><li>Gravity cycles</li><li>Pre-vacuum cycles</li><li>Flash cycles</li></ul>As a Class 5 integrating indicator, this product offers the highest level of chemical sterility assurance, equivalent in performance claims to a biological indicator. This broad compatibility ensures immediate and dependable readout verification across all specified cycles.
Does this integrator provide an immediate readout?
Yes, the Crosstex Steamplus Class 5 Integrator is designed to provide an immediate readout, which enables the rapid assessment and verification of the sterilization cycle effectiveness immediately upon completion.
As a high-assurance chemical indicator, it offers several key features:
- Class 5 Performance: This integrator meets the rigorous performance claims of ST-60 and ISO 11140-1:2005 for Class 5 indicators, providing the highest level of chemical sterility assurance.
- Clear Results: It features distinct, easy-to-interpret pass/fail criteria.
- FDA Cleared: It is FDA cleared as equivalent in performance to a biological indicator for chemical monitoring.
- Versatile Use: The strip functions reliably across gravity, pre-vacuum, and flash steam sterilization cycles.
Are the integrators FDA cleared for assured performance?
Yes, the Crosstex Steamplus Class 5 Integrator is FDA cleared.
This high-assurance chemical indicator is specifically:
- FDA Cleared as equivalent in performance to a biological indicator (BI) for chemical monitoring.
- Tested to meet rigorous standards for Class 5 integrators, including ST-60 and ISO 11140-1:2005.
It provides the highest level of sterility assurance available from a chemical indicator, offering immediate readout confirmation for gravity, pre-vacuum, and flash steam cycles.
Does the integrator replace biological sterilization indicators?
No, the Crosstex Steamplus Class 5 Integrator does not replace the routine use of a biological indicator (BI). It is intended to complement, not substitute, mandatory BI testing protocols.
While it does not replace a BI, this integrator provides the highest tier of chemical sterility assurance:
- Highest Classification: It is a Class 5 Integrating Integrator, meeting rigorous ST-60 and ISO 11140-1:2005 performance standards.
- Performance Equivalence: It is FDA Cleared as functionally equivalent in performance to a biological indicator, offering high sterility assurance.
- Immediate Results: It provides a distinct pass/fail immediate readout suitable for gravity, pre-vacuum, and flash steam sterilization cycles.
Does the Class 5 Integrator offer immediate results?
Yes, the Crosstex Steamplus Class 5 Integrator is engineered for immediate readout, offering rapid and definitive verification of your steam sterilization process.
Key features regarding its performance include:
- Immediate Verification: Provides distinct pass/fail criteria immediately after the cycle concludes, allowing for quick interpretation of results.
- High Assurance: As a Class 5 Integrating Indicator, it offers the highest level of chemical assurance and is functionally equivalent in performance to a biological indicator (BI).
- Versatile Compatibility: It is reliable for use in all major steam sterilization cycles, including gravity, pre-vacuum, and flash cycles.
Does this Class 5 integrator offer the highest sterility assurance?
Yes, the Crosstex Steamplus is a Class 5 Integrating Integrator, providing the highest level of sterility assurance available from a chemical indicator.
This high level of assurance is based on its rigorous design and performance:
- Highest Classification: It is tested against the rigorous performance claims of ST-60 and ISO 11140-1:2005 standards.
- BI Equivalence: The integrator is FDA cleared as functionally equivalent in performance to a biological indicator (BI), offering maximum chemical verification.
- Immediate Results: It provides a fast, distinct pass/fail criteria and is suitable for use in gravity, pre-vacuum, and flash steam sterilization cycles.
Important Note: Although the Class 5 integrator offers exceptional chemical verification, it is designed to complement, and does not replace, the requirement for routine biological indicator testing.
Is this a high-performance Class 5 integrator?
Yes, the Crosstex Steamplus is confirmed as a Class 5 Integrating Integrator, offering the highest level of sterility assurance available from a chemical indicator.
This integrator meets rigorous performance claims and regulatory requirements:
- Standards Compliance: It is tested against the demanding ST-60 and ISO 11140-1:2005 standards.
- Regulatory Status: It is FDA cleared as equivalent in performance to a biological indicator.
This high performance ensures reliable monitoring across all major steam sterilization cycles, including gravity, pre-vacuum, and flash cycles.
Does this integrator meet high-performance standards?
Yes, the Crosstex Steamplus is a Class 5 Integrating Indicator, which represents the highest level of chemical indicator assurance. It is designed to provide sterility assurance functionally equivalent to a biological indicator (though it does not replace routine biological monitoring).
It is rigorously tested and compliant with key industry standards:
- ST-60
- ISO 11140-1:2005
This indicator is FDA Cleared and versatile, suitable for gravity, pre-vacuum, and flash steam sterilization cycles.
Which sterilization cycles are these integrators compatible with?
The Crosstex Steamplus Class 5 Integrator is designed for versatility, providing high-level sterility assurance across common steam sterilization processes. It is compatible with the following cycles:
- Gravity
- Pre-vacuum
- Flash steam sterilization
This integrator meets stringent performance claims tested to ST-60 and ISO 11140-1:2005 standards, and provides an immediate pass/fail readout for efficient assessment.
How long are the integrator strips?
The Crosstex Steamplus Class 5 Integrator strips are specifically designed for ease of use and handling. Each strip measures 4 inches long, facilitating easy removal from sterilization packs after the cycle is complete.