sterility assurance level


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level

 [lev´el]
relative position, rank, or concentration.
l's of care the six divisions of the health care system: preventive care, primary care, secondary or acute care, tertiary care, restorative care, and continuing care.
background level the usual intensity of a chemical or other stimulus in the environment.
confidence level the probability that a confidence interval does not contain the population parameter.
l's of consciousness see levels of consciousness.
lowest observed adverse effect level (LOAEL) (lowest observed effect level (LOEL)) in studies of the toxicity of chemicals, the lowest dosage level at which chronic exposure to the substance shows adverse effects; usually calculated for laboratory animals.
no observed adverse effect level (NOAEL) (no observed effect level (NOEL)) in studies of the toxicity of chemicals, the highest dosage level at which chronic exposure to the substance shows no adverse effects; usually calculated for laboratory animals.
level of significance a statistical measure that serves as the cutoff point used to determine whether a null hypothesis is retained or rejected; the probability of incorrectly rejecting the null hypothesis (see Type I error).
sterility assurance level (SAL) the probability that a process makes something sterile (see sterilization). An SAL of 10−6 is the recommended probability of survival for organisms on a sterilized device. This level means that there is less than or equal to one chance in a million that an item remains contaminated or nonsterile.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.
References in periodicals archive ?
(11.) Sterility Assurance Level: The probability of a microorganism's being present on a product unit after sterilization
"People are saying that if we don't have to drive the sterility assurance level to such a low value, that would open the door for products that are difficult to sterilize because they're so sensitive to sterilization processes, particularly radiation."
Most manufacturers of single use bioprocess systems employ the [VD.sub.max] methods to substantiate a radiation sterilization dose to achieve a SAL (Sterility Assurance Level) of [10.sup.-6].
The use of biological materials in medical devices that can support microbial growth dictates rapid sterilization to avoid increases in bioburden that could risk invalidating the required sterility assurance level."
Better sterility assurance level and reduced particle presence--The higher sterility assurance level is obtained through the concept of keeping the vial always closed.