Standards Development

Scope

The standard:

●        applies to design, installation, testing for a cryogenic storage system with automated nitrogen supply system used for preservation of biological material for clinical, diagnostic, therapeutic activities;

●        defines the minimum requirements for all components and equipment serving and forming an integral part of a cryogenic storage system;

●        applies both to newly built, cryogenic storage systems and to modifications, extensions and changes of use of cryogenic storage systems already in operation;

●        defines the minimum requirements of the infrastructure (e.g.  intended to contain components and installations serving the cryogenic storage system);

●        contains requirements relating to the commissioning, acceptance activities and documentation made available by the manufacturer.

This standard does not apply:

●        Cryogenic rooms without an automatic freezers filling system cryogenic container are outside the scope of this standard.

●        to additional components used within cryogenic rooms that are not permanently connected to the cryogenic pipeline and are therefore not an integral part of the cryogenic storage system;

●        to systems intended for the storage of material that require manual filling in order to maintain an adequate level of liquid nitrogen inside the cryogenic freezers;

●        the management, identification and traceability of biological samples;

●        the management of devices using CO2, that could be installed in the same room and the associated risks of CO2 poisoning;

●        the responsibilities of managing the biological samples in normal and emergency conditions;

●        the installation of the stationary cryogenic tank and its conformity with local requirements.