ISO/TC 84

About

Secretariat: DS

Secretary:

Bibi Nellemose
Chairperson (until end 2021):

Mr Paul Jansen
ISO Technical Programme Manager :

Ms Isabelle Vega

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.

Quick links

Work programme

Drafts and new work items
Business plans

TC Business plans for public review
Working area

on ISOTC and Public information folder
ISO Electronic applications

IT Tools that help support the standards development process

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