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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32

published ISO standards *

related to the TC and its SCs

of which 27 under the direct responsibility of ISO/TC 194

16

ISO standards under development *

related to the TC and its SCs

of which 14 under the direct responsibility of ISO/TC 194

28

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
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 organization management 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 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
OIE World Organization for Animal Health (OIE) A
WHO World Health Organization A

Date Month Location TC/SC Note
3-7 December 2018 Berlin (Germany) 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 Dipl.-Ing Karl Wenzelewski
Tel: +49 7231 9188-24
Fax: +49 7231 9188-33