Sobre

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

85

Normas ISO publicadas *

20

Normas ISO en desarrollo *

23
Miembros participantes
23
Miembros observadores

* la cifra incluye las actualizaciones

Referencia Título Tipo
ISO/TC 76/WG 1   Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment Grupo de trabajo
ISO/TC 76/WG 2   Rigid container systems and related accessories for parenterals and injectables Grupo de trabajo
ISO/TC 76/WG 4   Elastomeric parts and components and related secondary packaging components Grupo de trabajo
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
IEC/SC 62D Particular medical equipment, software, and systems IEC
ISO/TC 48 Laboratory equipment 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
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

 

Organizaciones de enlace (categorías A y B)
Sigla Título Categoría
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
WHO World Health Organization A

ISO/TC 76 - Secretaría

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