About

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.

Quick links

27

published ISO standards *

under the direct responsibility of ISO/TC 84

13

ISO standards under development *

under the direct responsibility of ISO/TC 84

30

Participating members

25

Observing members

* number includes updates

Reference Title Type
ISO/TC 84/WG 3 Needle-based injection systems - Injector, container and pen needle Working group
ISO/TC 84/WG 8 Sharps containers Working group
ISO/TC 84/WG 9 Catheters Working group
ISO/TC 84/WG 11 Syringes Working group
ISO/TC 84/WG 13 On-body delivery systems Working group
ISO/TC 84/WG 14 Needle-based injection system (NIS) - Electrotechnical requirements and test methods Working group
ISO/TC 84/WG 15 Device Change Management Working group
Liaison Committees to ISO/TC 84

The committees below can access the documents of ISO/TC 84 :

Reference Title ISO/IEC
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 medical devices ISO
ISO/TC 215 Health informatics 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 medical devices ISO
ISO/TC 215 Health informatics 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

ISO/TC 84 - Secretariat

DS Denmark
Danish Standards
Göteborg Plads 1
DK-2150 Nordhavn
Denmark

Tel: +45 39 96 61 01
Fax: +45 39 96 61 02

Secretariat direct:
Bibi Nellemose