Glossary

Molds that cannot reproduce by sexual means. Some pathogenic fungi such as Trichophyton, which causes athlete’s foot, belong to this family.

This German rating system, also available in several European, Asian, and South American countries, takes an outcome-oriented approach to evaluating building performance. Construction products are assessed in terms of their use in the wider building design context, as they will only deliver the expected benefits when used appropriately. The system evaluates products’ impact on overall building performance.

Device registration number (ORA AofC code)

Development

A person, or group, that designs and/or builds and/or documents and/or configures the hardware and/or software of computerized systems.

Development is used in the following context within this document: Control system development can be split into two main activities, software development and system build. The software development is concerned with how the Functional Specification will be translated into software functionality. The system build concerns itself with assembly of predefined hardware element to translate the software input/outputs into system functionality.

(ANSI) A systematic approach to software creation that defines development phases and specifies the activities, products, verification procedures, and completion criteria for each phase.

Synonym: Coding Standards.

(ICH Q3B (R2)) Studies conducted to scale-up, optimize, and validate the manufacturing process for a drug product.

(IEEE) Testing conducted during the development of a system or component, usually in the development environment by the developer.

The involved disciplines at an organization that conducted the original development (method, product, or process).

(ICH Q7) Departure from an approved instruction or established standard.

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.

A pressure relief device designed to remain open after operation. Generally refers to a rupture disk or breaking pin device.

The dew point is the temperature to which a given parcel of humid air must be cooled, at constant barometric pressure, for water vapor to condense into water. The condensed water is called dew. The dew point is a saturation temperature.

The dew point is the temperature to which a given parcel of humid air must be cooled, at constant barometric pressure, for water vapor to condense into water. The condensed water is called dew. The dew point is a saturation temperature.

Dextran is a complex, branched glucan (polysaccharide made of many glucose molecules) composed of chains of varying lengths (from 10 to 150 kilodaltons). It is used medicinally as an antithrombotic (anti-platelet), to reduce blood viscosity, and as a volume expander in anemia.

An intermediate polysaccharide compound resulting from the hydrolysis of starch to maltose by amylase enzymes.

Division of Food Contact Notifications (CFSAN)

Data Flow Diagram

Division of Facilities Engineering and Maintenance (NCTR)

Dairy and Food Industries Supply Association (E-3-A Standards)

Division of Food Labeling, Standards, and Compliance (CFSAN)