Tissue release based on dosimetry instead of sterility testing
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Dosimetric Release
,Tissue produced from one donor at one time using one set of instruments and supplies
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Lot
Any entity that receives, stores, and provides tissue directly to an end-user for
transplantation. Tissue dispensing services may or may not be tissue banks,
depending on what other functions they perform
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Tissue Dispensing Service
Indicates mandatory compliance
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Shall/Must
Any material that is used in the processing of tissue, including, but not limited to,
incoming tissue, water, alcohol, acid, containers, and closures
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, In-Process Material
The probability of a single viable microorganism
occurring on a product after sterilization
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Sterility Assurance Level (SAL)
An undesirable effect or untoward complication in a recipient consequent to or
reasonably related to tissue transplantation
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Adverse Outcome
Conformance to pre-established specifications, attributes, requirements, regulations,
and/or standards
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Quality
, The identification of tissue, reagents, supplies, materials, and equipment as not suitable
for use, or that has not yet been characterized as being suitable for use
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Quarantine
Indicates recommended compliance
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Should/May
Activities performed to systematically observe and record data to characterize the
environment to identify conditions under which the potential may exist for contamination
or cross-contamination of tissue
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Environmental Monitoring
The time interval from asystole to subjecting vascular tissue to transport solution and wet
ice temperatures at recovery
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Dosimetric Release
,Tissue produced from one donor at one time using one set of instruments and supplies
Give this one a try later!
Lot
Any entity that receives, stores, and provides tissue directly to an end-user for
transplantation. Tissue dispensing services may or may not be tissue banks,
depending on what other functions they perform
Give this one a try later!
Tissue Dispensing Service
Indicates mandatory compliance
Give this one a try later!
Shall/Must
Any material that is used in the processing of tissue, including, but not limited to,
incoming tissue, water, alcohol, acid, containers, and closures
Give this one a try later!
, In-Process Material
The probability of a single viable microorganism
occurring on a product after sterilization
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Sterility Assurance Level (SAL)
An undesirable effect or untoward complication in a recipient consequent to or
reasonably related to tissue transplantation
Give this one a try later!
Adverse Outcome
Conformance to pre-established specifications, attributes, requirements, regulations,
and/or standards
Give this one a try later!
Quality
, The identification of tissue, reagents, supplies, materials, and equipment as not suitable
for use, or that has not yet been characterized as being suitable for use
Give this one a try later!
Quarantine
Indicates recommended compliance
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Should/May
Activities performed to systematically observe and record data to characterize the
environment to identify conditions under which the potential may exist for contamination
or cross-contamination of tissue
Give this one a try later!
Environmental Monitoring
The time interval from asystole to subjecting vascular tissue to transport solution and wet
ice temperatures at recovery
Give this one a try later!
