Glossary Terms (Simple List)
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Sterility Assurance Level (SAL)
Probability that a batch of product is sterile. (TR28)
Probability of a single viable microorganism occurring on or in an item after sterilization. Note: The term SAL takes a quantitative value, generally 10-6. When applying this quantitative value to assurance of sterility, an SAL of 10-6 has a lower value but provides a greater assurance of sterility than an SAL of 10-3. (TR3) (TR61)
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Sterility Test
Test performed to determine if viable microorganisms are present. (TR28) (TR62)
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Sterilization
A process used to render a product free of viable organisms with a specified probability. (TR01) (TR30) (TR69)
A process by which something is rendered sterile (i.e., moist heat, dry heat, chemical, irradiation); normally validated at 106 organism reduction. (TR70)
Validated process used to render product free from viable microorganisms (TR13) (TR26)
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Sterilization Cycle
A sequence of defined operating parameters (e.g., time, temperature and pressure) and conditions required to render an item sterile. (TR01) (TR30) (TR48)
A sequence of defined operating parameters (e.g., time and temperature) required to render an item sterile. (TR3)
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Sterilization Process
A process used to render a product free of viable organisms with a specified probability. (TR3)
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Sterilization Run
Execution of a sterilization cycle. (TR01)
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Sterilizer Specification
Documents that define sterilizer system attributes and how they should be met. (TR48)
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Sterilizer Specification (Design Specification (DS))
A set of specifications and information related to the installation features including equipment, hardware and software) of the system that will ensure the realization of the user requirements. [Synonym: Detailed Design Specification (DDS] (TR48)
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Sterilizer Specification (Functional Specification (FRS))
A description of functional attributes and operational characteristics of the system that will ensure fulfillment of the user requirements. [Synonym: Functional Requirement Specification, Functional Design Specification] (TR48)
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Sterilizer Specification (User Requirement Specification (URS))
A description of features and performance requirements of a system that will fulfill the needs of the end user. (TR48)