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Glossary

ISO 13485
A quality standard that covers the manufacture of medical device and complies with the European IVD Directive.

ISO 8 Clean Room
An international standard for the management systems and purity level of clean rooms.

ISO 14001
An international standard for environmental management.

ISO 8655
An international quality standard for the manufacture and testing of piston-operated volumetric apparatus.

ISO 17025
General competence requirements for carrying out tests and calibrations. An accredited pipette calibration laboratory that calibrates pipettes according to precise technical requirements.

Lean management
A production philosophy based on producing goods with lower inputs and to the customer’s requirements. The aim is to ensure that the entire production and logistics chain is as streamlined as possible. It is important that the process as a whole runs smoothly. In practice, this means seeking to minimise lost working time and materials as well as unnecessary processes without negative impacts on the amount and quality of manufactured products. The process thus also yields added value for customers, as they get the products they want at the lowest cost and as fast as possible.

Pepsinogen I and II
Pepsinogens are the inactive precursors to pepsin enzymes. They are secreted in the stomach and converted to pepsin in the presence of hydrochloric acid. Pepsinogen I is formed by the primary cells of the corpus (the upper part of the stomach). Pepsinogen II is produced throughout the entire stomach and also in the duodenum. Some Pepsinogen diffuses into the bloodstream and can therefore be measured from a blood sample. The greater the atrophy of the corpus, as a result of long-term Helicobacter pylori infection or autoimmune disease, the lower the concentration of Pepsinogen I – or the Pepsinogen ratio (PgI:PgII) – that will be measured in a blood sample, and the greater the risk of gastric or oesophageal cancer and the risk of malabsorption of vitamin B12, iron, calcium and certain drugs.

Point-of-care test
A diagnostic test that can immediately be used to analyse a patient that arrives for examination.

RoHS
Restriction of the Use of Hazardous Substances – an EU Directive that seeks to harmonise member state legislation on limiting the use of hazardous electric and electrical waste.

WEEE
Waste Electrical and Electronic Equipment Directive – an EU Directive that seeks to reduce the generation of electric and electrical waste and to promote its reuse and recycling.