Sobre

Alcance

Standardization of requirements and guidance in the field of quality management and corresponding general aspects, for products with a health purpose, including connectors for liquid and gases.

Excluded:

  • generic quality management standards dealt with by ISO / TC 176;
  • quality management standards for pharmaceutical products and healthcare services;

    • Note: Products with a health purpose include products for use in relation to health, including medical devices, adjacent products [or could also say accessories] and those with a risk profile similar to medical devices.

ISO/TC 210
Visit the Technical Committee's own website for more information.

Enlaces rápidos

Objetivos de Desarrollo Sostenible

Este comité contribuye con 10 normas a los siguientes Objetivos de Desarrollo Sostenible:

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure
10
Reduced Inequalities
31

Normas ISO publicadas *

12

Normas ISO en desarrollo *

40
Miembros participantes
29
Miembros observadores

* la cifra incluye las actualizaciones

Referencia Título Tipo
ISO/TC 210/AHG   Ad-hoc group for ISO 22740 Grupo de trabajo
ISO/TC 210/AHG 3   Review of handbook for ISO 13485 Grupo de trabajo
ISO/TC 210/AHG 4   Assessment of ISO 13485 Grupo de trabajo
ISO/TC 210/AHG 5   Collaboration with IMDRF on guidance documents Grupo de trabajo
ISO/TC 210/AHG 6   Monitoring of PMS Grupo de trabajo
ISO/TC 210/ATTF   Arabic translation task force Grupo de trabajo
ISO/TC 210/CAG   Chair Advisory Group Grupo de trabajo
ISO/TC 210/JWG 1   Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices Grupo de trabajo
ISO/TC 210/JWG 2   Joint ISO/TC 210-IEC/SC 62A WG : Medical device software Grupo de trabajo
ISO/TC 210/JWG 3   Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability Grupo de trabajo
ISO/TC 210/JWG 4   Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors Grupo de trabajo
ISO/TC 210/STTF   Spanish translation task force Grupo de trabajo
ISO/TC 210/TG 1   Review of Strategic Business Plan Grupo de trabajo
ISO/TC 210/WG 1   Application of quality systems to medical devices Grupo de trabajo
ISO/TC 210/WG 2   General aspects stemming from the application of quality principles to medical devices Grupo de trabajo
ISO/TC 210/WG 3   Symbols and nomenclature for medical devices Grupo de trabajo
ISO/TC 210/WG 5   Connectors for reservoir delivery systems Grupo de trabajo
ISO/TC 210/WG 6   Application of post market surveillance systems to medical devices Grupo de trabajo
ISO/TC 210/WG 7   Good engineering maintenance management Grupo de trabajo
Comités de enlace a ISO/TC 210

Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 210:

Referencia Título ISO/IEC
IEC/SC 62A Common aspects of medical equipment, software, and systems IEC
IEC/SC 62D Particular medical equipment, software, and systems IEC
IEC/TC 56 Dependability IEC
IEC/TC 62 Medical equipment, software, and systems IEC
ISO/IEC JTC 1/SC 7 Software and systems engineering ISO/IEC
ISO/IEC JTC 1/SC 42 Artificial intelligence ISO/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 121 Anaesthetic and respiratory equipment ISO
ISO/TC 150 Implants for surgery ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems 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 172/SC 5 Microscopes and endoscopes ISO
ISO/TC 172/SC 7 Ophthalmic optics and instruments ISO
ISO/TC 173 Assistive products ISO
ISO/TC 173/SC 2 Classification and terminology ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 176/SC 2 Quality systems ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 209 Cleanrooms and associated controlled environments ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 262 Risk management ISO
ISO/TC 289 Brand evaluation ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 314 Ageing societies ISO
ISO/TC 338 Menstrual products ISO

 

Comités de enlace de ISO/TC 210

ISO/TC 210 pueden acceder a los documentos de los comités que aparecen a continuación:

Referencia Título ISO/IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1/SC 7 Software and systems engineering ISO/IEC
ISO/IEC JTC 1/SC 42 Artificial intelligence ISO/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 121 Anaesthetic and respiratory equipment ISO
ISO/TC 145/SC 3 Graphical symbols for use on equipment 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 157 Non-systemic contraceptives and STI barrier prophylactics ISO
ISO/TC 168 Prosthetics and orthotics ISO
ISO/TC 170 Surgical instruments ISO
ISO/TC 172/SC 7 Ophthalmic optics and instruments ISO
ISO/TC 173 Assistive products ISO
ISO/TC 173/SC 2 Classification and terminology ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 176/SC 1 Concepts and terminology ISO
ISO/TC 176/SC 2 Quality systems ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 209 Cleanrooms and associated controlled environments ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 215 Health informatics ISO
ISO/TC 262 Risk management ISO
ISO/TC 289 Brand evaluation ISO
ISO/TC 304 Healthcare organization management ISO

 

Organizaciones de enlace (categorías A y B)
Sigla Título Categoría
AHWP Asian Harmonization Working Party A
DITTA Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association A
EUROM European Federation of Precision Mechanical and Optical Industries A
IACRC Inter-American Coalition for Regulatory Convergence A
IMDRF International Medical Device Regulators Forum A
MedTech Europe Alliance of European medical technology industry associations A
WFSA World Federation of Societies of Anaesthesiologists A
WHO World Health Organization 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
GEDSA The Global Enteral Device Supplier Association C
Fecha Mes Ubicación TC/SC Nota
3-7 March 2025 Minato City (Japan) ISO/TC 210  

* Información definitiva, pero la reunión aún no se ha convocado formalmente
** Provisional

ISO/TC 210 - 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

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