Sobre
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Secretaría: DS
Responsable de comité: -
Presidente/a (hasta el final 2024):Mr Robert R. Nesbitt
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Responsable de programa técnico de ISO [TPM]:Responsable editorial de ISO [EM]:
- Fecha de creación: 1956
Alcance
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.
Enlaces rápidos
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Programa de trabajo
Borradores y nuevos elementos de trabajo -
Planes de negocio
Planes de negocio de TC para revisión pública -
Área de trabajo
Documentos de trabajo (se requiere cuenta de usuario) -
Aplicaciones electrónicas de ISO
Herramientas de TI que apoyan el proceso de desarrollo de normas -
Material público
Consulte los documentos que pone a disposición este grupo
Este comité contribuye con 37 normas a los siguientes Objetivos de Desarrollo Sostenible:
Comités de enlace a ISO/TC 84
Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 84:
| Referencia | Título | 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 |
Comités de enlace de ISO/TC 84
ISO/TC 84 pueden acceder a los documentos de los comités que aparecen a continuación:
| Referencia | Título | 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 |
Organizaciones de enlace (categorías A y B)
| Sigla | Título | Categoría |
|---|---|---|
| MedTech Europe | Alliance of European medical technology industry associations | A |
| UNICEF | United Nations Children's Fund | A |
| WHO | World Health Organization | A |
Organizaciones de enlace (categoría C)
Los enlaces C participan a nivel de grupo de trabajo
| Sigla | Título | Categoría |
|---|---|---|
| EBN | European Biosafety Network | C |
ISO/TC 84 en las noticias
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 …