International Standard for medical device testing updated
Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
About
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Secretariat: DIN
Committee Manager: -
Chairperson (until end 2023):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.
Quick links
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Work programme
Drafts and new work items -
Business plans
TC Business plans for public review -
Working area
Working documents (user account required) -
ISO Electronic applications
IT Tools that help support the standards development process
This committee contributes with 24 standards to the following Sustainable Development Goal:
Liaison Committees to ISO/TC 194
The committees below can access the documents of ISO/TC 194:
| Reference | Title | ISO/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 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 |
|---|---|---|
| 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 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 |
| VAMAS | Versailles Project on Advanced Materials and Standards | A |
| WHO | World Health Organization | A |
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
No more rashes and tears with new OBP collection on biological evaluation
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.