Glossary

Secure Hypertext Transfer Protocol

An enzyme that specifically degrades RNA or singlestranded DNA to 5’ mononucleotides. Purified from the filamentous fungus Aspergillus oryzae, S1 nuclease is used in assessing the extent of a hybridization reaction by removing unpaired regions. It is also used to remove the sticky ends of restriction fragments. In S1 mapping, the coding region of a gene is detected by performing mRNA-DNA hybridization and removing unpaired DNA with S1 nuclease.

Staphylococcus Aureus

Sulphanilic Acid

Scientific Advisory Committee

Suppliers Advisory Council (ISPE term)

Better known as beer yeast, ordinary yeast. Yeast used in rDNA research.

South African Development Community

Society of Automotive Engineers

Serious Adverse Effect

Passed in 1990, the SMDA has greatly broadened FDA authority over the medical devices industry. The act requires Medical Device Reports; not filing the reports can result in fines. The SMDA also formally changed the 510(k) procedure, which was originally intended to be a notification procedure, to a premarket approval procedure. The SMDA also permitted the assessment of substantial civil penalties for violating the Food, Drug, and Cosmetic Act relating to devices.

The Safe Threshold Value is calculated from the Acceptable Daily Exposure and is the upper limit for statistical analysis used to determine the process capability and cleaning validation limits.

(DOD) Freedom from those conditions that can cause death, injury, occupational illness, or damage to or loss of equipment or property, or damage to the environment.

(DOD) A term applied to a condition, event, operation, process or item of whose proper recognition, control, performance or tolerance is essential to safe system operation or use; e.g., safety critical function, safety critical path, safety critical component.

(DOD) Those computer software components and units whose errors can result in a potential hazard, or loss of predictability or control of a system.

A plan to incorporate the requirements of both the construction firm and owner with regard to project safety. Construction safety hazard analysis reviews should occur to identify activities that have higher than normal risk to employees and property. Specific plans, procedures and training should be implemented to address the hazards identified.

An automatic pressure-actuated relief device suitable for use either as a safety valve or relief valve, depending on application.

(ASME) A pressure relief valve characterized by rapid opening or pop action or by opening in proportion to the increase in pressure over the opening pressure, depending on application.

(ASME) A pressure relief valve actuated by inlet static pressure and characterized by rapid opening or pop action.

An automatic pressure-actuated relief device suitable for use either as a safety valve or relief valve, depending on application.

A safety/environmental critical instrument is an instrument whose failure may have a direct effect on safety/environment.

A safety/environmental critical instrument is an instrument whose accuracy/failure may have a direct effect on safety/environment.

A base, obtained from aniline; aniline pink; used as a stain in histology.

Sucrose Acetate Isobutyrate

Sterility Assurance Level