ISO/TC 84

About

Secretariat: DS

Secretary:

Bibi Nellemose
Chairperson (until end 2021):

Mr Paul Jansen
ISO Technical Programme Manager :

Ms Sonia Sarmiento

ISO Editorial Programme Manager :

Ms Christelle Gansonre
Creation date: 1956

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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This committee contributes with 24 standards to the following Sustainable Development Goals:

Good Health and Well-being

Reduced Inequalities

published ISO standards *

under the direct responsibility of ISO/TC 84

ISO standards under development *

under the direct responsibility of ISO/TC 84

Participating members

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
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

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

Email: dansk.standard@ds.dk

Web: http://www.ds.dk/

Secretariat direct:

Bibi Nellemose

Email: bn@ds.dk

Devices for administration of medicinal products and catheters