ISO/CD 25802

Biotechnology — Requirements for the production and quality control of immunomagnetic beads

Scope

This document specifies minimum requirements for the production and quality control of immunomagnetic beads.
This document also describes general quality attributes for immunomagnetic beads as well as common methods for evaluating quality attributes for end-use.
This document is applicable to the research and development of immunomagnetic beads, and to the application field of immunomagnetic beads, e.g. cell sorting, protein purification, and microbial separation.
NOTE For manufacturing of therapeutic products, cell-based products, users can refer to applicable GMP requirements and standards such as ISO 20399.