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  • Abstract:
    This document applies to refrigerated and frozen storage equipment equipped with refrigeration equipment and operated for subsequent storage applications. This document applies to: a) Refrigerated goods (chilled/frozen products) for laboratory use in a storage temperature range of -150 °C to +15 °C; b) Chilled blood products (blood and blood component preparations) for transfusion purposes in a storage temperature range of 2 °C to 6 °C c) refrigerated medicinal products in a storage temperature range of 2 °C to 8 °C; d) storage of already frozen blood plasma for transfusion in a storage temperature range from <kleiner =>-30 °C. This document applies to refrigerated and frozen storage devices intended for an installation room with an ambient temperature range according to Table 2 and a relative humidity <kleiner => 75%. Blood plasma storage devices that operate in accordance with the specifications of this document ensure that a product temperature of -27 °C is not exceeded at any location at any time. This document does not apply to: - Cooled incubators according to DIN 12880; - refrigerated cells or refrigerated containers over 2000 l; - cooling during transport.
  • Document number:
    DIN 13277
  • Issuing date:
    2021-02-01
  • Document type:
    Norm-Entwurf
  • Title:
    Refrigerators and freezers for the medical sector - Definitions, requirements, testing
  • Author:
    Medical Standards Committee
  • Search term:
    Ambient temperature; Atmosphere; Blood conserves; Blood plasma; Climate; Condensates; Controls; Cooling; Cooling equipment; Definitions; Effective volumes; Equipment; Fitness for purpose; Hygiene; Indoors; Instruments; Laboratory medicine; Marking; Refrigeration; Refrigerators; Safety requirements; Specification (approval); Specimens; Storage; Temperature; Temperature differences; Temperature fluctuations; Temperature test; Testing
  • Application areas:
    03.40 Heizungs-, Kälte-, Klima-, Kochanlagen (Trocknen, Befeuchten, Räuchern)
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BA Biologische Gefährdungen im Allgemeinen; DA Mechanische Gefährdungen im Allgemeinen; GC Schall (Lärm); GL Kontakt mit heißen oder kalten Medien (Oberflächen, Umgebungen)
  • ICS:
    11.120.99 Other standards related to pharmaceutics; 97.040.30 Domestic refrigerating appliances
  • Price:
    102,80 EUR
  • Update flag:
    Unchanged
  • Deadline for comments:
    2021-05-15