Standards Development

Scope

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure that collections of biological material and associated data are of appropriate quality.

This document is applicable to all organizations performing biobanking. This can include biobanking of biological material:

a) from multicellular organisms (e.g. human, animal, fungus and plant);

b) from microorganisms;

c) derived from sources such as environmental samples (e.g. soil, sediment, water, air).

Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.

This document does not apply to biological material intended for therapeutic use.

NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes, ISO 15189 and other clinical standards are intended to apply first and foremost.