About
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Secretariat: DIN (Germany)
Committee Manager: -
Chairperson (until end 2026):Mr Jeremy Tinkler
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1988
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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This committee contributes with 34 standards to the following Sustainable Development Goals:
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 |
ISO/TC 194 - Secretariat
DIN (Germany)
DIN Deutsches Institut für Normung e.V.
Am DIN-Platz, Burggrafenstraße 6
D-10787 Berlin
Germany
D-10787 Berlin
Germany
Tel: +49 30 2601-0
Fax: +49 30 26 01 12 31
Web: http://www.din.de
ISO/TC 194 in the news
Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
Don't put your consumers and patients in harm's way. Ensure your medical devices are tried and tested prior to marketing and use with the new OBP collection for biological evaluation.