ISO/WD 26013

Biotechnology — Bioprinting — Requirements for the printing process

Scope

This document gives basic and generally applicable requirements and recommendations for relevant criteria and test methods for all phases of 3D bioprinting with cell-containing bioink in order to enable objective testing and evaluation of quality and reproducibility for individual phases and the overall printing process.
In addition, specific requirements for selected, exemplary printing systems and materials are also given within the framework of this standard.
The focus of this document is on the printing of living systems and the production of structures that can be used for regenerative medicine, the provision of test systems for the pharmaceutical industry and for basic cell biology studies (e.g. disease models). This document is applicable for manufacturers and users of bioprinters and bioinks. Excluded from the scope of this document are:
— the incoming goods inspection of raw materials; 
— the biological maturation phase of the printed construct;
— long-term, product-specific investigations and applications;
— software for creating CAD models and operating bioprinters;
— 3D printed drugs.