ISO/TC 210

Sobre

Secretaría: ANSI (United States)

Responsable de comité:

Mr Amir Aboutaleb
Presidente/a (hasta el final 2025):

Mr Scott A. Colburn
Responsable de programa técnico de ISO [TPM]:

Mrs Kirsi Silander-van Hunen

Responsable editorial de ISO [EM]:

Ms Valeria Agamennone
Fecha de creación: 1994

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.

Visit the Technical Committee's own website for more information.

Enlaces rápidos

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 12 normas a los siguientes Objetivos de Desarrollo Sostenible:

Good Health and Well-being

Quality Education

Industry, Innovation and Infrastructure

Reduced Inequalities

Responsible Consumption and Production

Peace, Justice and Strong Institutions

Normas ISO publicadas *

Normas ISO en desarrollo *

Miembros participantes

Miembros observadores

* la cifra incluye las actualizaciones

Estructura
Enlaces

Referencia	Título	Tipo
ISO/TC 210/AHG	Ad-hoc group for ISO 22740	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/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
DITTA	Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association	A
EUROM	European Federation of Precision Mechanical and Optical Industries	A
GHWP	Global Harmonization Working Party	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

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

Sobre

Secretaría: ANSI (United States)

Alcance

ISO/TC 210

Enlaces rápidos

Programa de trabajo

Planes de negocio

Área de trabajo

Aplicaciones electrónicas de ISO

Material público

Estructura

Enlaces