Normas ISO – Biotecnologia

ISO/AWI 23511 [Under development] | Biotechnology — General requirements for cell line authentication

Acesse:

https://www.iso.org/contents/data/standard/07/58/75854.html

Situação:

Em desenvolvimento

ISO/AWI 24190 [Under development] | Biotechnology – Analytical Methods – Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses

Acesse:

https://www.iso.org/contents/data/standard/07/80/78060.html

Situação:

Em desenvolvimento

ISO/DTS 23494-1 [Under development] | Biotechnology – Provenance information model for biological material and data – Part 1: Design concepts and general requirements

https://www.iso.org/contents/data/standard/08/07/80715.html

Situação:

Em desenvolvimento

ISO 20391-2:2019 | Biotechnology – Cell counting – Part 2: Experimental design and statistical analysis to quantify counting method performance

Acesse:

https://www.iso.org/contents/data/standard/06/78/67892.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/AWI 20399 [Under development] | Biotechnology – Ancillary materials present during the production of cellular therapeutic products

Acesse:

https://www.iso.org/standard/79399.html

Situação:

Em andamento

ISO/AWI 20688-2 [Under development] | Biotechnology – Nucleic acid synthesis – Part 2: General definitions and requirements for the production and quality control of synthesized gene fragment, gene, and genome

Acesse:

https://www.iso.org/standard/75852.html

Situação:

Em desenvolvimento

ISO/CD 20691 [Under development] | Biotechnology – Requirements for data formatting and description in the life sciences for downstream data processing and integration workflows

Acesse:

https://www.iso.org/standard/68848.html

Situação:

Em desenvolvimento

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

ISO/FDIS 24651 [Under development] | Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow

https://www.iso.org/contents/data/standard/07/91/79141.html

Situação:

Em desenvolvimento