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

38

Published ISO standards *

7

ISO standards under development *

29
Participating members
29
Observing members

* number includes updates

Reference Title Type
ISO/TC 84/AG 1   Expert panel Working group
ISO/TC 84/WG 3   Needle-based injection systems - Injector, container and pen needle Working group
ISO/TC 84/WG 8   Sharps injury protection Working group
ISO/TC 84/WG 9   Catheters Working group
ISO/TC 84/WG 10   Needles Working group
ISO/TC 84/WG 11   Syringes Working group
ISO/TC 84/WG 16   Drug delivery system requirements for paediatrics and other demographics Working group
ISO/TC 84/WG 17   Specification and demonstration of reliability of single-use drug delivery systems 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 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

 

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 products with a health purpose including medical devices 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

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
EBN European Biosafety Network C

ISO/TC 84 - Secretariat

DS [Denmark]

Danish Standards
Göteborg Plads 1
DK-2150 Nordhavn
Denmark

Tel: +45 39 96 61 01