Sobre
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Secretaría: DIN (Germany)
Responsable de comité: -
Presidente/a (hasta el final 2026):Mr Jeremy Tinkler
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Responsable de programa técnico de ISO [TPM]:Responsable editorial de ISO [EM]:
- Fecha de creación: 1988
Alcance
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.
Enlaces rápidos
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Programa de trabajo
Borradores y nuevos elementos de trabajo -
Planes de negocio
Planes de negocio de TC para revisión pública -
Área de trabajo
Documentos de trabajo (se requiere cuenta de usuario) -
Aplicaciones electrónicas de ISO
Herramientas de TI que apoyan el proceso de desarrollo de normas -
Material público
Consulte los documentos que pone a disposición este grupo
Este comité contribuye con 34 normas a los siguientes Objetivos de Desarrollo Sostenible:
Comités de enlace a ISO/TC 194
Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 194:
| Referencia | Título | 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 |
Comités de enlace de ISO/TC 194
ISO/TC 194 pueden acceder a los documentos de los comités que aparecen a continuación:
| Referencia | Título | 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 |
Organizaciones de enlace (categorías A y B)
| Sigla | Título | Categoría |
|---|---|---|
| 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 |
Organizaciones de enlace (categoría C)
Los enlaces C participan a nivel de grupo de trabajo
| Sigla | Título | Categoría |
|---|---|---|
| EC - European Commission | European Commission | C |
ISO/TC 194 - Secretaría
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 en las noticias
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.