Sobre
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Secretaría: DIN (Germany)
Responsable de comité: -
Presidente/a (hasta el final 2024):Mr Marc von Pawlowski
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Responsable de programa técnico de ISO [TPM]:Responsable editorial de ISO [EM]:
- Fecha de creación: 1951
Alcance
Standardization of containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.
Excluded:
- performance requirements of metered devices and supplies intended for self-administration of medicinal products, non-prefilled syringes and needles and intravascular catheters, covered by ISO/TC 84;
- devices intended for respiratory therapy, covered by ISO/TC 121;
- dental cartridge syringe holder, covered by ISO/TC 106.
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 105 normas a los siguientes Objetivos de Desarrollo Sostenible:
Comités de enlace a ISO/TC 76
Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 76:
Referencia | Título | ISO/IEC |
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IEC/SC 62D | Particular medical equipment, software, and systems | IEC |
ISO/TC 48 | Laboratory equipment | ISO |
ISO/TC 48/SC 7 | Non-measuring equipment made of glass, plastic and ceramics | ISO |
ISO/TC 61/SC 9 | Thermoplastic materials | ISO |
ISO/TC 63 | Glass containers | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106/SC 4 | Dental instruments | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
Comités de enlace de ISO/TC 76
ISO/TC 76 pueden acceder a los documentos de los comités que aparecen a continuación:
Referencia | Título | ISO/IEC |
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ISO/TC 45/SC 2 | Testing and analysis | ISO |
ISO/TC 61/SC 9 | Thermoplastic materials | ISO |
ISO/TC 63 | Glass containers | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106/SC 4 | Dental instruments | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 76 - Secretaría
DIN (Germany)
D-10787 Berlin
Germany