Biobanking

What is biobanking?

Biobanking involves the systematic management and preservation of biological material and associated data so that they can be used for research and development.

Quality and traceability are important aspects of the entire process.

The standard for biobanking

The standard SS-EN ISO 20387:2021, Biotechnology – Biobanking – General requirements for biobanking, sets requirements for, among other things, competence, impartiality and quality management.

The standard is intended to help build confidence that biological material and associated data are of the quality required for their intended purpose in research and development.

Swedac accredits biobanks in accordance with SS-EN ISO 20387:2021.

As part of the accreditation process, Swedac assesses whether the biobank has the competence and capability required to meet the requirements of the standard.

Currently, Swedac offers accreditation for biobanking activities involving human material. Accreditation in additional areas may be considered based on needs and demand.

Information for organisations seeking accreditation

Biobanks handling human material are accredited against SS-EN ISO 20387:2021 and Swedac’s applicable regulations on accreditation.

The standard includes requirements for, among other things, how biological material and associated data are to be managed, stored and traced. It also includes requirements for quality control.

Requirements and guidance documents