ISO/CD TR 22758

Biotechnology — Biobanking — Implementation guide for ISO 20387

Apstrakt

This document provides guidance to biobanks on how to implement:


governance and management requirements;


technical and operational requirements;


resource and competence requirements of ISO 20387.


This document expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks.
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).
This document does not apply to biological material intended for therapeutic use.