DIN Standards Committee Health Technologies
Biotechnology - Biobanking - General requirements for biobanking; German version EN ISO 20387:2020/A11:2024
Abstract
A11 includes the Annex ZA for DIN EN ISO 20387, which shows the relationship between this European Standard and the requirements of regulation (EC) No 765/2008 of the European Parliament and of the council of 9 July 2008 setting out the requirements for accreditation and repealing regulation (EEC) No 339/93 aimed to be covered. DIN EN ISO 20387 specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. DIN EN ISO 20387 is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. 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. DIN EN ISO 20387 does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or 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.
Begin
2024-06-28
WI
JT001083
Planned document number
DIN EN ISO 20387/A11
Project number
17600105
Responsible national committee
NA 176-09-02-02 AK - Biobanks/Bioresources
Responsible european committee
CEN/CLC/JTC 1 - Criteria for conformity assessment bodies
