Managing biorisk: why we need ISO 35001
With virus testing at the centre of many COVID strategies, the ISO standard for managing biorisk has arrived at just the right time.
Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.
Excluded:
This committee contributes with 18 standards to the following Sustainable Development Goals:
The committees below can access the documents of ISO/TC 212:
Reference | Title | ISO/IEC |
---|---|---|
IEC/TC 66 | Safety of measuring, control and laboratory equipment | IEC |
ISO/CASCO | Committee on conformity assessment | ISO |
ISO/REMCO | Committee on reference materials | ISO |
ISO/TC 34 | Food 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 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 150/SC 7 | Tissue-engineered medical products | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for medical devices | ISO |
ISO/TC 215 | Health informatics | ISO |
ISO/TC 276 | Biotechnology | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
ISO/TC 212 can access the documents of the committees below:
Reference | Title | ISO/IEC |
---|---|---|
ISO/CASCO | Committee on conformity assessment | ISO |
ISO/REMCO | Committee on reference materials | ISO |
ISO/TC 34 | Food 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 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 150/SC 7 | Tissue-engineered medical products | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 207/SC 1 | Environmental management systems | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for medical devices | ISO |
ISO/TC 215 | Health informatics | ISO |
ISO/TC 262 | Risk management | ISO |
ISO/TC 276 | Biotechnology | ISO |
ISO/TC 283 | Occupational health and safety management | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
Acronym | Title | Category |
---|---|---|
AHWP | Asian Harmonization Working Party | A |
ASLM | African Society for Laboratory Medicine | A |
BBMRI-ERIC | Biobanking and BioMolecular resources Research Infrastructure | A |
BIPM | International Bureau of Weights and Measures | A |
EC - European Commission | European Commission | A |
EC4 | European Communities Confederation of Clinical Chemistry | A |
EFLM | European Federation of Clinical Chemistry and Laboratory Medicine | A |
EUROM | European Federation of Precision Mechanical and Optical Industries | A |
ICSH | International Council for Standardization in Haematology | A |
IFBLS | International Federation of Biomedical Laboratory Science | A |
IFCC | International Federation of Clinical Chemistry and Laboratory Medicine | A |
ILAC | International Laboratory Accreditation Cooperation | A |
IUPAC | International Union of Pure and Applied Chemistry | A |
MedTech Europe | Alliance of European medical technology industry associations | A |
OECD | Organisation for Economic Co-operation and Development, OECD | A |
WASPaLM | World Association of Societies of Pathology and Laboratory Medicine | A |
WHO | World Health Organization | A |
C liaisons participate at the level of a Working Group
Acronym | Title | Category |
---|---|---|
A-PBA | Asia-Pacific Biosafety Association | C |
ABSA | American Biological Safety Association | C |
BACAC | Biosafety Association for Central Asia and the Caucasus | C |
EBSA | European Biosafety Association | C |
IFBA | International Federation of Biosafety Associations | C |
OIE | World Organization for Animal Health (OIE) | C |