About

Scope

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.

Quick links

70

published ISO standards *

under the direct responsibility of ISO/TC 76

14

ISO standards under development *

under the direct responsibility of ISO/TC 76

19

Participating countries

22

Observing countries

* number includes updates

Reference Title Type
ISO/TC 76/WG 1 Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment Working group *
ISO/TC 76/WG 2 Rigid container systems and related accessories for parenterals and injectables Working group *
ISO/TC 76/WG 4 Elastomeric parts and components and related secondary packaging components Working group *
ISO/TC 76/WG 6 Primary packaging materials for medicinal products Working group *

* The convener can be reached through the secretariat (See contact information below)

Liaison Committees to ISO/TC 76

The committees below can access the documents of ISO/TC 76 :

Reference Title ISO/IEC
IEC/SC 62D Electromedical equipment IEC
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 medical devices ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO
Liaison Committees from ISO/TC 76

ISO/TC 76 can access the documents of the committees below :

Reference Title ISO/IEC
ISO/TC 48/SC 5 Quality of glassware 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 145 Graphical symbols ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal 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 medical devices ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO
ISO/TC 215 Health informatics ISO
Organizations in liaison
Acronym Title Liaison type
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
WHO World Health Organization A

ISO/TC 76 - Secretariat

DIN Germany
DIN Deutsches Institut für Normung e.V.
Am DIN-Platz
Burggrafenstrasse 6
D-10787 Berlin
Germany

Tel: +49 30 26 01-0
Fax: +49 30 26 01 12 31

Secretariat direct:
Mrs Anna Perbliess
Tel: +49 30 2601-2665
Fax: +49 30 2601-42665