Glossary

(NIST) Period of time beginning when a software product is conceived and ending when the product is no longer available for use. The software lifecycle is typically broken into phases denoting activities such as requirements, design, programming, testing, installation, and operation and maintenance.

A set of activities designed to evaluate the process by which products are developed or manufactured.

(IEEE) A planned and systematic pattern of all actions necessary to provide adequate confidence that an item or product conforms to established technical requirements.

(IEEE) The probability that software will not cause the failure of a system for a specified time under specified conditions. The probability is a function of the inputs to and use of the system in the software. The inputs to the system determine whether existing faults, if any, are encountered.

The ability of a program to perform its required functions accurately and reproducibly under stated conditions for a specified period of time.

(IEEE) An evaluation of software elements to ascertain discrepancies from planned results and to recommend improvement. This evaluation follows a formal process. Synonymous: Software Audit.

(IEEE) Analysis of the safety-critical design elements affected directly or indirectly by the change to show the change does not create a new hazard, does not impact on a previously resolved hazard, does not make a currently existing hazard more severe, and does not adversely affect any safety-critical software design element.

(IEEE) Verification that the safety-critical portions of the design are correctly implemented in the code.

(IEEE) Verification that the safety-critical portion of the software design correctly implements the safety-critical requirements and introduces no new hazards.

(IEEE) Analysis evaluating software and interface requirements to identify errors and deficiencies that could contribute to a hazard.

(IEEE) Analysis demonstrating that safety requirements have been correctly implemented and that the software functions safely within its specified environment. Tests may include; unit level tests, interface tests, software configuration item testing, system level testing, stress testing, and regression testing.

Substance made up of organic and/or mineral material(s), forming a deposit on an inert (i.e. non-biological) surface. ISO 14698-3.NOTE: Organic matter contained in soiling can only constitute a nourishing substrate for microorganisms in the presence of water activity which enables their development. This standard only considers wet soiling.

A metal joining process wherein coalescence is produced by heating to suitable temperatures and by using a nonferrous alloy fusible at temperatures below 427ºC (800ºF) and having a melting point below that of the base metals being joined. The filler metal is distributed between closely fitted surfaces of the joint by capillary attraction. In general, solders are lead-tin alloys and may contain antimony, bismuth, and other elements.

Nutrient media that has been solidified, such as by addition of agar.

Cancer cells which grow as a solid mass.

Stated in terms of volume of solvent in milliliters needed to dissolve one gram of solute at a temperature between 15ºC and 25ºC.Very solubleless than 1Freely soluble1 – 10Soluble10 –30Sparingly soluble30 – 100Slightly soluble100 – 1000Very slightly soluble1000 – 10,000Practically Insolublemore than 10,000The term “partly soluble” is used to describe a mixture where only some of the components dissolve.

Generally used in reference to vaccine production. As opposed to a whole live or attenuated virus, a soluble antigen is a fragment of the virus that produces immunity. Also refers to large molecular weight polysaccharides from some bacteria which can act as vaccines.

The silica present in the water that has actually dissolved in the water.

The substance that dissolves to form ions in solution.

A substance, usually a solid or semisolid, that forms a chemically and physically homogeneous mixture with one or more other substances, usually a liquid.

A substance, usually a solid or semisolid, that forms a chemically and physically homogeneous mixture with one or more other substances, usually a liquid.

A substance that is dissolved in a solvent; the part of a solution that is uniformly dispersed in another substance.

A mixture in which the components are uniformly dispersed. All solutions consist of some kind of a solvent (such as water or other liquid) that dissolves another substance, usually a solid.

The interior surfaces of the circuits which are used exclusively for supply and recirculation of cleaning and/or sanitizing solutions.

As defined by IAFP “the interior surfaces of the circuits which are used exclusively for supply and recirculation of cleaning and/or sanitizing solutions”. Stainless steel and higher alloys interior surface finishes shall meet the requirements of Part SF of ASME BPE.