About

Scope

Standardization in the field of biotechnology processes that includes the following topics:

  • Terms and definitions;
  • biobanks and bioresources;
  • analytical methods;
  • bioprocessing;
  • data processing including annotation, analysis, validation, comparability and integration;
  • metrology.

ISO/TC 276 Biotechnology will work closely with related committees in order to identify standardization needs and gaps, and collaborate with other organisations to avoid duplications and overlapping standardization activities.

The committee will not pursue subjects within the scope of other TCs including but not limited to ISO/TC 212 and ISO/TC 34/SC 16.

Quick links

38

Published ISO standards *

of which 25 under the direct responsibility of ISO/TC 276

26

ISO standards under development *

of which 17 under the direct responsibility of ISO/TC 276

40
Participating members
15
Observing members

* number includes updates

Reference Title Type
ISO/TC 276/SC 1 Analytical methods Subcommittee
ISO/TC 276/SC 2 Microphysiological systems and Organ-on- Chip Subcommittee
ISO/TC 276/AHG 1   Organoids Working group
ISO/TC 276/CAG   Chair’s Advisory Group Working group
ISO/TC 276/WG 2   Biobanks and bioresources Working group
ISO/TC 276/WG 4   Bioprocessing for cells and related entities Working group
ISO/TC 276/WG 5   Data processing and integration Working group
ISO/TC 276/WG 6   Nucleic acid- and protein-based devices Working group

 

Joint working groups under the responsibility of another committee
Reference Title
ISO/TC 34/SC 16/JWG 11 Joint ISO/TC 34/SC 16 - ISO/TC 276 WG: Biobanking for agriculture and food production
ISO/TC 212/JWG 6 Joint ISO/TC 212 - ISO/TC 276 WG: Quality practice for detection of SARS-CoV-2
Liaison Committees to ISO/TC 276

The committees below can access the documents of ISO/TC 276:

Reference Title ISO/IEC
IEC/TC 62 Medical equipment, software, and systems IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1/SC 29 Coding of audio, picture, multimedia and hypermedia information ISO/IEC
ISO/TC 34/SC 5 Milk and milk products ISO
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 190/SC 4 Biological characterization ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 215 Health informatics ISO
ISO/TC 215/SC 1 Genomics Informatics ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 331 Biodiversity ISO
ISO/TC 334 Reference materials ISO

 

Liaison Committees from ISO/TC 276

ISO/TC 276 can access the documents of the committees below:

Reference Title ISO/IEC
IEC/TC 62 Medical equipment, software, and systems IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1/SC 29 Coding of audio, picture, multimedia and hypermedia information ISO/IEC
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 86 Refrigeration and air-conditioning ISO
ISO/TC 121/SC 6 Medical gas supply systems ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 215 Health informatics ISO
ISO/TC 215/SC 1 Genomics Informatics ISO
ISO/TC 220 Cryogenic vessels ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 272 Forensic sciences ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 331 Biodiversity ISO
ISO/TC 347 Data-driven agrifood systems ISO

 

Organizations in liaison (Category A and B)
Acronym Title Category
ANRRC Asian Network of Research Resource Centers A
AOAC INTERNATIONAL AOAC INTERNATIONAL, Association of Analytical Communities A
BBMRI-ERIC Biobanking and BioMolecular resources Research Infrastructure A
EC - European Commission European Commission A
ESBB European, Middlle Eastern and African Society for Biobanking (ESBB) A
GA4GH Global Alliance for Genomics and Health A
IARC International Agency for Research on Cancer A
ICH The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use A
ILAC International Laboratory Accreditation Cooperation A
ISBER International Society for Biological and environmental repositories A
ISCT International Society for Cell & Gene Therapy A
MIRRI Microbial Resource Research Infrastructure A
VAMAS Versailles Project on Advanced Materials and Standards A

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
Avicenna Alliance Avicenna Alliance C
BIOINDUSTRY 4.0​ BIOINDUSTRY 4.0​ C
EvolveBBMRI EvolveBBMRI C
Instand-NGS4P Integrated and standardized NGS workflows for Personalised therapy C
LSEA Belt and Road Life Sciences Economy Alliance C
MFA Microfluidics Association C
MICROBE The Microbiome Biobanking (RI) Enabler C
Date Month Location TC/SC Note
31-7 May-June 2025 Cairns City (Australia) ISO/TC 276 *

* Information definite but meeting not yet formally convened
** Provisional

ISO/TC 276 - Secretariat

DIN [Germany]

DIN Deutsches Institut für Normung e.V.
Am DIN-Platz, Burggrafenstraße 6
D-10787 Berlin
Germany

Tel: +49 30 2601-0
Fax: +49 30 26 01 12 31