What is ISO/TS 23565 about?
ISO/TS 23565 discusses biotechnology and specifies minimum requirements and general considerations for equipment, consisting of hardware, software, and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing, and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use.
ISO/TS 23565 gives guidance on the design, use, and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e., supplier or user, and phase of the involved task, i.e., design, use, or maintenance
ISO/TS 23565 applies to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It applies to devices used for monitoring equipment status.
It does not apply to processing equipment for cells for therapeutic use used ...