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.

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Sustainable Development Goals

This committee contributes with 23 standards to the following Sustainable Development Goals:

3
Good Health and Well-being
10
Reduced Inequalities
34

published ISO standards *

under the direct responsibility of ISO/TC 84

10

ISO standards under development *

under the direct responsibility of ISO/TC 84

31

Participating members

26

Observing members

* number includes updates

Reference Title Type
ISO/TC 84/JWG 1 Joint ISO/TC 84 - ISO/TC 76: Sterile blood sample collection needles for single use - Requirements and test methods Working group
ISO/TC 84/SG 1 Specification and demonstration of reliability of single use drug delivery systems Working group
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
ISO/TC 84/WG 16 Drug delivery system requirements for paediatrics and other demographics 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 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

 

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

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
EBN European Biosafety Network C
Date Month Location TC/SC Note
18 October 2019 Haacht (Belgium) ISO/TC 84  

* Information definite but meeting not yet formally convened
** Provisional

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
Web:

Secretariat direct:

Bibi Nellemose