DANSK DS/EN 13485 PDF

This document specifies the technical and functional characteristics for all types of thermometers (electronic, mechanical, etc.) for equipping the means used for the transport, storage and distribution of temperature sensitive goods and for measuring the ambient or internal temperature of the products between −80 °C and +85 °C. It specifies the test methods which allow the verification of the equipment's conformity to suitability and performance requirements. It applies to the whole thermometer and indicating device(s). The temperature sensor(s) can be integrated into the thermometer or remote from it (wired or wireless external temperature sensor(s)). It does not specify the location of the thermometer and its sensors with respect to types of usage such as transport, storage and distribution. NOTE – Examples for the transport, storage and distribution of temperature sensitive goods between −80 °C and +85 °C include chilled, frozen, deep frozen and quick-frozen food; ice cream; fresh and hot food; pharmaceuticals; blood and organs; chemicals; biologicals; electronic and mechanical devices; flowers, plants and bulbs; raw materials and liquids; animals; art and furnishings.