About
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Secretariat: DS (Denmark)
Committee Manager: -
Chairperson (until end 2027):Mr Michael Roe
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1956
Scope
Standardization of the performance of metered devices and supplies intended for administration of medicinal products, and standardization of syringes, needles and catheters.
Excluded:
- non catheter devices intended for diagnostic use;
- anaesthetic and respiratory equipment, including lung ventilators and oxygen therapy devices, covered by ISO/TC 121;
- cartridge systems for dental use, covered by ISO/TC 106;
- specific requirements for components and devices, including prefilled syringes, covered by ISO/TC 76.
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This committee contributes with 37 standards to the following Sustainable Development Goals:
Liaison Committees to ISO/TC 84
The committees below can access the documents of ISO/TC 84:
| Reference | Title | ISO/IEC |
|---|---|---|
| ISO/TC 48 | Laboratory equipment | ISO |
| ISO/TC 48/SC 8 | Volume measuring instruments | ISO |
| ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
| ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
| ISO/TC 173/SC 2 | Classification and terminology | ISO |
| ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
Liaison Committees from ISO/TC 84
ISO/TC 84 can access the documents of the committees below:
| Reference | Title | ISO/IEC |
|---|---|---|
| ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
| ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
| ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
Organizations in liaison (Category A and B)
| Acronym | Title | Category |
|---|---|---|
| MedTech Europe | Alliance of European medical technology industry associations | A |
| UNICEF | United Nations Children's Fund | A |
| WHO | World Health Organization | A |
Organizations in liaison (Category C)
C liaisons participate at the level of a Working Group
| Acronym | Title | Category |
|---|---|---|
| EBN | European Biosafety Network | C |
ISO/TC 84 in the news
As the biggest vaccination campaign in history gets underway, all hands are on deck to secure and supply the billions of syringes needed for the COVID-19 vaccines.
With more than 16 billion injections administered around the world every year, devices for administering medication into the human body are big business. The ISO committee of experts that develops standards …
Some 16 billion injections are administered around the world every year, each one bringing with it a risk of transmitting disease. Reusing a syringe increases that risk exponentially. ISO is tackling the …