1 Scope
This document specifies requirements for primary containers intended for the storage
of biological materials in biobanks. In addition to general requirements, this document
also specifies special requirements depending on the storage conditions, the biological
material and the intended use, as well as requirements for documentation and quality
control. These requirements establish the framework for ensuring that primary containers
meet the necessary quality criteria.
This document specifies test criteria and test methods that enable proof of conformity
with the requirements.
This document is primarily aimed at manufacturers that produce primary containers
for the storage of biological materials. Biobanks, submitters and users of biological
material, and organizations that monitor or control the work of biobanks can also
use this document.
NOTE For primary containers intended for biological material for therapeutic use, other
requirements can apply.