ISO/AWI 23511 [Under development]

ISO 20387:2018 | Biotechnology – Biobanking – General requirements for biobanking

Acesse:

https://www.iso.org/contents/data/standard/06/78/67888.htm

Situação:

publicada

ISO 23033:2021 | Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

Acesse:

https://www.iso.org/standard/74367.html

Situação:

publicada

ISO 20395:2019 | Biotechnology – Requirements for evaluating the performance of quantification methods for nucleic acid target sequences – qPCR and dPCR

Acesse:

https://www.iso.org/contents/data/standard/06/78/67893.html

Situação:

publicada

ISO/TS 20399-3:2018 | Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 3: Best practice guidance for ancillary material users

https://www.iso.org/contents/data/standard/07/09/70983.html

Situação:

Publicada

ISO 22758:2020 | Biotechnology — Biobanking — Implementation guide for ISO 20387

Acesse:

https://www.iso.org/standard/73829.html

Situação:

publicada

ISO/FDIS 24603 [Under development] | Biotechnology – Biobanking – Requirements for the establishment, maintenance, characterization and distribution of pluripotent stem cells

https://www.iso.org/contents/data/standard/07/90/79046.html

Situação:

Em desenvolvimento