Sobre

Alcance

Standardization of processes and equipment for sterilization of health care products.

Enlaces rápidos

67

Normas ISO publicadas *

14

Normas ISO en desarrollo *

34
Miembros participantes
20
Miembros observadores

* la cifra incluye las actualizaciones

Referencia Título Tipo
ISO/TC 198/WG 1   Industrial ethylene oxide sterilization Grupo de trabajo
ISO/TC 198/WG 2   Radiation sterilization Grupo de trabajo
ISO/TC 198/WG 3   Moist heat sterilization Grupo de trabajo
ISO/TC 198/WG 4   Biological indicators Grupo de trabajo
ISO/TC 198/WG 5   Terminology Grupo de trabajo
ISO/TC 198/WG 6   Chemical indicators Grupo de trabajo
ISO/TC 198/WG 7   Packaging Grupo de trabajo
ISO/TC 198/WG 8   Microbiological methods Grupo de trabajo
ISO/TC 198/WG 9   Aseptic processing Grupo de trabajo
ISO/TC 198/WG 12   Information for reprocessing of resterilizable devices Grupo de trabajo
ISO/TC 198/WG 13   Washer-disinfectors Grupo de trabajo
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

Tel: +1 703 525 48 90
Fax: +1 703 276 07 93