VDI 5708 Blatt 1:2023-12 - Draft

The technology of bioprinting has the potential to shape both research and industrial applications in the field of life sciences in the coming years. This standard provides academic and industrial users with guidance on the reproducible processing of bio-inks into 2D and 3D structures using additive manufacturing, in order to provide the basis for better comparability of R&D results. This standard focuses on drop-on-demand (DOD) inkjet printing. This standard takes into account the following phases of the overall process: the pre-phase of the printing process (bio-ink formulation and printing system qualification), the printing phase (printing process execution and control) and the immediately subsequent post-phase of the printing process (geometric and biological product characterization). This standard defines relevant criteria and test methods for all phases in order to enable an objective review and evaluation of quality and reproducibility for individual phases and the overall process. In addition to basic and generally applicable requirements for bioprinting, specific requirements for selected printing systems and materials are also explained as examples within the framework of this standard. The focus is on the production of structures that can be used in regenerative medicine, the provision of test systems for the pharmaceutical industry and for basic cell biological studies (e. g. disease models). The standard is thus aimed at the manufacturers and users of bioprinters and bio-inks.

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