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.

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31

published ISO standards *

related to the TC and its SCs

of which 26 under the direct responsibility of ISO/TC 194

15

ISO standards under development *

under the direct responsibility of ISO/TC 194

29

Participating members

19

Observing members

* number includes updates

Reference Title Type
ISO/TC 194/SC 1 Tissue product safety Sub committee
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 investigations 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 *

* The convener can be reached through the secretariat (See contact information below)

Liaison Committees to ISO/TC 194

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

Reference Title ISO/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 Optics and photonics ISO
ISO/TC 173 Assistive products for persons with disability ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare administration ISO
Liaison Committees from ISO/TC 194

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

Reference Title ISO/IEC
ISO/TC 106 Dentistry ISO
ISO/TC 106/SC 2 Prosthodontic materials ISO
ISO/TC 121/SC 3 Lung ventilators and related equipment 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 medical devices ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare administration ISO
Organizations in liaison
Acronym Title Liaison type
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
OIE World Organization for Animal Health (OIE) A
WHO World Health Organization A
Date Month Location TC/SC Note
16-20 October 2017 Seoul (Korea, Republic of) 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 26 01-0
Fax: +49 30 26 01 12 31

Secretariat direct:
Mr Karl Wenzelewski
Tel: +49 7231 9188-24
Fax: +49 7231 9188-33