About

Scope

Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.

Quick links

37

Published ISO standards *

16

ISO standards under development *

34
Participating members
18
Observing members

* number includes updates

Reference Title Type
ISO/TC 194/CAG   Chair's Advisory Group Working group
ISO/TC 194/WG 1   Systematic approach to biological evaluation and terminology Working group
ISO/TC 194/WG 2   Degradation aspects related to biological testing Working group
ISO/TC 194/WG 3   Animal protection aspects Working group
ISO/TC 194/WG 4   Clinical investigation and evaluation of medical devices in humans Working group
ISO/TC 194/WG 5   Cytotoxicity Working group
ISO/TC 194/WG 6   Mutagenicity, carcinogenicity and reproductive toxicity Working group
ISO/TC 194/WG 7   Systemic toxicity Working group
ISO/TC 194/WG 8   Irritation, sensitization Working group
ISO/TC 194/WG 9   Effects on blood Working group
ISO/TC 194/WG 10   Implantation Working group
ISO/TC 194/WG 11   Allowable limits for leachable substances Working group
ISO/TC 194/WG 12   Sample preparation and reference materials Working group
ISO/TC 194/WG 13   Toxicokinetics Working group
ISO/TC 194/WG 14   Material characterization Working group
ISO/TC 194/WG 15   Strategic approach to biological assessment Working group
ISO/TC 194/WG 16   Pyrogenicity Working group
ISO/TC 194/WG 17   Nanomaterials Working group
ISO/TC 194/WG 18   Attributes of medical devices relevant to biological risk assessment Working group
ISO/TC 194/WG 19   Tissue product safety Working group
Liaison Committees to ISO/TC 194

The committees below can access the documents of ISO/TC 194:

Reference Title ISO/IEC
IEC/TC 62 Medical equipment, software, and systems IEC
IEC/TC 124 Wearable electronic devices and technologies IEC
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 84 Devices for administration of medicinal products and catheters ISO
ISO/TC 106 Dentistry ISO
ISO/TC 150 Implants for surgery ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 157 Non-systemic contraceptives and STI barrier prophylactics ISO
ISO/TC 172/SC 7 Ophthalmic optics and instruments ISO
ISO/TC 173 Assistive products ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 338 Menstrual products ISO

 

Liaison Committees from ISO/TC 194

ISO/TC 194 can access the documents of the committees below:

Reference Title ISO/IEC
IEC/TC 124 Wearable electronic devices and technologies IEC
ISO/TC 106 Dentistry ISO
ISO/TC 106/SC 2 Prosthodontic materials ISO
ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care ISO
ISO/TC 150 Implants for surgery ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems ISO
ISO/TC 150/SC 6 Active implants ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare organization management ISO

 

Organizations in liaison (Category A and B)
Acronym Title Category
FDI World Dental Federation (FDI) A
MedTech Europe Alliance of European medical technology industry associations A
OECD Organisation for Economic Co-operation and Development, OECD A
VAMAS Versailles Project on Advanced Materials and Standards A
WHO World Health Organization A
WOAH World Organization for Animal Health (WOAH) A

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
EC - European Commission European Commission C
Date Month Location TC/SC Note
21-25 October 2024 Saint-Denis (France) ISO/TC 194  

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

ISO/TC 194 - Secretariat

DIN [Germany]

DIN Deutsches Institut für Normung e.V.
Am DIN-Platz, Burggrafenstraße 6
D-10787 Berlin
Germany

Tel: +49 30 2601-0
Fax: +49 30 26 01 12 31