Sobre
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Secretaría: ANSI
Responsable de comité: -
Presidente/a (hasta el final 2025):Mr Richard Bancroft
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Responsable de programa técnico de ISO [TPM]:Responsable editorial de ISO [EM]:
- Fecha de creación: 1990
Alcance
Standardization of processes and equipment for sterilization of health care products.
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 57 normas a los siguientes Objetivos de Desarrollo Sostenible:
Comités de enlace a ISO/TC 198
Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 198:
| Referencia | Título | ISO/IEC |
|---|---|---|
| IEC/SC 62A | Common aspects of medical equipment, software, and systems | IEC |
| IEC/TC 62 | Medical equipment, software, and systems | IEC |
| IEC/TC 66 | Safety of measuring, control and laboratory equipment | IEC |
| ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
| ISO/TC 106/SC 4 | Dental instruments | ISO |
| ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
| ISO/TC 122 | Packaging | ISO |
| ISO/TC 150 | Implants for surgery | ISO |
| ISO/TC 150/SC 6 | Active implants | ISO |
| ISO/TC 150/SC 7 | Tissue-engineered medical products | ISO |
| ISO/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ISO |
| ISO/TC 168 | Prosthetics and orthotics | ISO |
| ISO/TC 170 | Surgical instruments | ISO |
| ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
| ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
| ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
| ISO/TC 304 | Healthcare organization management | ISO |
Comités de enlace de ISO/TC 198
ISO/TC 198 pueden acceder a los documentos de los comités que aparecen a continuación:
| Referencia | Título | ISO/IEC |
|---|---|---|
| ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
| ISO/TC 85 | Nuclear energy, nuclear technologies, and radiological protection | ISO |
| ISO/TC 106/SC 4 | Dental instruments | ISO |
| ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
| ISO/TC 122 | Packaging | ISO |
| ISO/TC 150 | Implants for surgery | ISO |
| ISO/TC 150/SC 6 | Active implants | ISO |
| ISO/TC 150/SC 7 | Tissue-engineered medical products | ISO |
| ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
| ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
| ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
| ISO/TC 276 | Biotechnology | ISO |
| ISO/TC 304 | Healthcare organization management | ISO |
Organizaciones de enlace (categorías A y B)
| Sigla | Título | Categoría |
|---|---|---|
| IAEA | International Atomic Energy Agency | A |
| MedTech Europe | Alliance of European medical technology industry associations | A |
| WFHSS | World Federation for Hospital Sterilisation Sciences | A |
| Fecha | Mes | Ubicación | TC/SC | Nota |
|---|---|---|---|---|
| 28 | June 2024 | Galway (Ireland) | ISO/TC 198 |
* Información definitiva, pero la reunión aún no se ha convocado formalmente
** Provisional
ISO/TC 198 - Secretaría
ANSI [United States]
Association for the Advancement of Medical Instrumentation
901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States
Arlington 22203 VA
United States
Tel: +1 703 525 48 90
Fax: +1 703 276 07 93
ISO/TC 198 en las noticias
New guidance on the sterilization of health care products just published.