Glossary

An organization that sets standards for electronic products and components which are adopted by the safety standards agencies of many countries.

An organization that sets international standards. It deals with all fields except electrical and electronics which is governed by IEC. Synonymous: International Standards Organization.

Provides consistent and technically advanced requirements that can be used across the country to provide comprehensive regulations of modern plumbing systems. Setting minimum regulations for plumbing facilities in terms of performance objectives, the IPC provides for the acceptance of new and innovative products, materials, and systems.

Formerly, Consultive Committee for International Telephony and Telegraphy. An international organization for communications standards.

International Research on Permanent Authentic Records in Electronic Systems

The stage in the cell cycle when the cell is not dividing; the stage follows telophase of one division and extends to the beginning of prophase in the next division. DNA replication occurs during this stage.

Possible SQL Injection attack, value has been removed

(IEEE) A computer program that translates and executes each statement or construct of a computer program before translating and executing the next. The interpreter must be resident in the computer each time a program (source code file) written in an interpreted language is executed.

The suspension of a process to handle an event external to the process.

A technique to notify the CPU that a peripheral device needs service, i.e., the device has data for the processor or the device is awaiting data from the processor. The device sends a signal, called an interrupt, to the processor. The processor interrupts its current program, stores its current operating conditions, and executes a program to service the device sending the interrupt. After the device is serviced, the processor restores its previous operating conditions and continues executing the interrupted program. A method for handling constantly changing data.

A software tool which analyzes potential conflicts in a system as a result of the occurrences of interrupts.

The objective is to explore the data of a given batch run, to understand events chronologically. Here, all information comes from a unique batch run. This differs from : Inter Batch.

The route of administration for certain parenteral drugs into muscle tissue. Procedure is called an injection.

The route of administration of certain parenteral drugs into veins. Procedure is called an infusion.

A segment of DNA sequence of a eukaryotic gene, not represented in the mature (final) mRNA transcript, because it is spliced out of the primary transcript before it can be translated; a process known as intron splicing. Some genes of higher eukaryotes contain a large number of introns, which make up the bulk of the DNA sequence of the gene. Introns are also found in genes whose RNA transcripts are not translated, namely eukaryotic rRNA and tRNA genes. In these cases the intron sequence does not appear in the functional RNA molecule.

A testing technique using erroneous (invalid, abnormal, or unexpected) input values or conditions.

These are not only inputs outside the valid range for data to be input, i.e. when the specified input range is 50 to 100, but also unexpected inputs, especially when these unexpected inputs may easily occur; e.g., the entry of alpha characters or special keyboard characters when only numeric data is valid, or the input of abnormal command sequences to a program.

(NBS) Test data that lays outside the domain of the function the program represents.

A device, including a transitional device that is the object of an investigation.

Medical devices must receive FDA approval before being marketed (since the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act). Similar to an IND, an IDE allows companies to sell and use a limited number of devices for investigation purposes and clinical trials. The IDE exempts the device not only from the pre-market approval regulation but also from a host of other reporting and recording regulations. The Amendments divided medical devices into three classes.

The definition of an Investigational Medicinal product (IMP) is provided in Directive 2001/20/EC, Article 2 (d) (2), as “a pharmaceutical form of an active substance or placebo being tested or used as areference in a clinical trial, including products already with a marketing authorization but odofied (change to dosage form, or its primary or secondary packaging) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gainfurther information about the authorized form”.Medicinal products with a marketing authorization (MA) are classified as IMPs when they are to be used as the test drug or reference drug in a clinical trial, provided they are used or assembled (formulated or packaged) in a way different from the authorized form, or used for an unauthorized indication, or used to gain further information about the authorized form. On this basis, provided that the requirement(s) are met, reference products used as comparators should be considered as IMPs.

Packaged and labeled drug product including placebos and comparators intended for use in a clinical trial.

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization, but used or assembled (formulated or packaged) in a way different from the authorized form, or when used to gain further information about the authorized form. (Synonyms: Investigational Product, Trial Product, Trial Medication, Clinical Supplies, and Study Drug, etc.)

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization, but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.