Study Commissions

The Study Commissions are responsible for the quality of the collection of Standards developed, and they have the duty of periodically reviewing those Standards, keeping them updated and harmonized with similar international standards or even working in the technical adaptation for the Brazilian reality.

Participation in those commissions is voluntary, through representatives of class entities, universities, health services, government and non-government organs, manufacturers, importers and distributors of products and services.

26:020.01 – Common Aspects of Electromedical Equipment Safety Study Commission

Develop Technical Standards about common safety aspects and essential performance of medical equipment in general, including manufacturing aspects, tests, installation, use and application of the equipment used in the medical practice, considering systems, devices, accessories and defining a terminology, concepts, definitions and symbols related.

26:020.02 – Electromedical Equipment Study Commission

Develop Private Standards and Technical Reports for electric equipment used in the medical practice. Those documents cover safety and/or equipment performance aspects, as well as terminologies, concepts, definitions and symbols related.

Note: Examples of the types of equipment covered by the scope of CE 26:020.02 includes equipment used for diagnostic, monitoring or to help treat patients.

Exclusions: Diagnostic equipment by image and medical equipment that use high energy ionizing radiation.

26:020.03 – Study Commission of Image Diagnostic Equipment

Prepare international safety and performance publications for all types of image diagnostic equipment (for example, X ray equipment for image diagnostic, computed tomography, magnetic resonance equipment), including equipment associated and accessories, as well as quality procedures to be applied during the life cycle of the image equipment (for example, acceptance tests and constancy tests).

26:020.04 – Study Commission of Radiotherapy Equipment, Nuclear Medicine and Radiation Dosimetry

Standardization in the fields of transfusion, infusion and injection equipment for medical use, regarding terminology, requirements, procedures, test methods, specifications for quality and performance of materials and components.

26:030.01 – Comissão de Estudo de Dispositivos e Produtos de Plástico, Vidro e Elastômeros para Uso Médico e Sistema de Coleta de Sangue

Normalização no campo de transfusão, infusão e equipamentos de injeção para uso médico, no que concerne a terminologia, requisitos, procedimentos, métodos de ensaios, especificações para qualidade e performance de materiais e componentes.

26:040.01 – Syringes and Needles Study Commission

Standardization of the performance of the medical devices and materials intended for medication administration, standardization of syringes, needles and intravascular catheters.

26:050.01 – Dental Equipment Study Commission

Standardization in oral health, including: terms and definitions, safety, performance, specification requirements for dental products and clinically relevant lab test methods, all of which contribute to improve the global health.

26:050.02 – Dental Implant Study Commission

Standardization in the field of dental implants concerning terminology, requirements and test methods.

26:050.03 – Dental Diamond Burs Study Commission

Standardization in the field of diamond burs for dental use concerning terminology, manufacturing, specifications, requirements and test methods.

26:050.04 – Restorer, Shutter and Prosthetic Dental Material Study Commission

Standardization in the dental field, including restorer, shutter and dental material for prosthetics concerning terms and definitions, safety, performance, specification requirements for dental products and clinically relevant test methods, all of which contribute to improve global health.

Note: Mirror study commission of ISO/TC 106/SC 1 and SC 2 – Dentistry/Filling and restorative materials and prosthodontic materials.

26:060.01 – Respiratory and Anesthesia Equipment Study Commission

Standardization of anesthesia and respiratory equipment, supplies, related devices and supply systems.

26:060.02 – Study Commission for Hospital Use Gases, their Processes and Installations

Establish the requirements, tests and other conditions for hospital use gases, their processes and installations.

26:070.01 – Study Commission of Implants for Orthopedics and Body Contours

Standardization in the field of implants for orthopedics and body contours, covering terminology, specifications and test methods, as well as the evaluation of explanted products, in order to facilitate the global regulation, associated instrumentation and materials employed in manufacturing and application.

Note: Mirror Study Commission of ISO/TC 150 (activities under direct responsibility, including ISO/TC 150/WG 7; ISO/TC 150/WG 8 and ISO/TC 150/WG 10); ISO/TC 150/SC 1; ISO/TC 150/SC 4; ISO/TC 150/SC 5.

26:070.02 – Study Commission for Heart Implants

Standardization of heart valves, valve prosthetics, stents and extracorporeal systems

Note: Mirror Study Commission of ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems.

26:070.03 – Study Commission of Implants and Biological Replacements

Standardization in the instrumentation field and confection methods for medical products built by Tissue Engineering (TEMPs – Tissue Engineering Medical Products), concerning feasibility tests of biological implants, as well as basic materials and compounds used in the manufacturing of biological replacements, as well as the construction of biological replacements or equipment, which will be implanted surgically in the body temporarily or permanently for diagnostic or therapeutic purposes.

Note: This Study Commission will monitor the works of ISO/TC 150/SC 7 – Tissue-engineered medical products.

26:070.04 – Comissão de Estudo de Implantes para Substituição de Articulação e de Ossos

Normalização no campo de implantes para substituição de articulações e de ossos, no que concerne aos requisitos, métodos de ensaios e terminologia.

NOTA Esta Comissão de Estudo será espelho do ISO/TC 150/SC 4 – Bone and joint replacements.

26:070.05 – Comissão de Estudo de Implantes para Osteossíntese e para Coluna

Normalização no campo de implantes para osteossíntese e para coluna, no que concerne aos requisitos, métodos de ensaios e terminologia.

NOTA Esta Comissão de Estudo será espelho do ISO/TC 150/SC 5 – Osteosynthesis and spinal devices.

26:070.06 – Active Implants Study Commission

Standardization in the field of active medical implants (for example, implantable defibrillators and pacemakers) concerning terminology, requirements and test methods.

Note: This Study Commission will be a mirror of ISO/TC 150/SC 6 – Active implants.

26:070.15 – Comissão de Estudo de Implantes para Cirurgia

Normalização no campo de implantes para cirurgia, no que concerne aos requisitos, métodos de ensaios e terminologia.

NOTA Esta Comissão de Estudo espelhará as atividades desenvolvidas pelos Grupos de Trabalho do ISO/TC 150. Atualmente, encontram-se ativos os ISO/TC 150/WG 7 – Fundamental standards, ISO/TC 150/WG 8 – Breast implants, ISO/TC 150/WG 10 – Use and retrieval of surgical implants e ISO/TC 150/WG 12 – Implant coatings.

26:080.01 – Study Commission of Mechanical Contraceptives

Standardization of non-systemic contraceptives and prophylactic barriers for sexually transmitted diseases.

26:090.01 – Study Commission of Health Products Sterilization

Standardization of processes and equipment for sterilization of health products.

26:120.01 – Wheelchair Study Commission

Standardization in the wheelchair field concerning terminology, requirements and test methods.

26:120.02 – Study Commission for Classification and Terminology of Support Products for Individuals with Disabilities or Disabled

Standardization in the field of support products for persons with disabilities or disabled, concerning classification and terminology.

Note: Mirror Study Commission of ISO/TC 173/SC 2 – Assistive products for persons with disabilityClassification and terminology.

26:120.03 – Study Commission for Hearing Devices

Standardization in the field of hearing devices, concerning requirements and test methods.

Note: Study Commission responsible for the adoption of Standards on hearing devices of IEC/TC 29 – Electroacoustics. Agreement between ABNT/CB-26 and ABNT/CB-03.

26:130.01 – Study Commission of Medical Devices’ Biological Evaluation

Standardization concerning the biological evaluation of medical devices covering materials and products, for health and dental, including applicable test methods.

26:130.02 – Study Commission for Antimicrobial Agent on Products for Use in Health Services

Standardization in the field of antimicrobial agents’ application on products for use in health services.

26:150.01 – Study Commission for Management of Quality and General Corresponding Aspects of Health Products

Development of Standards in the area of health products quality management and general aspects standards arising from the application of quality principles on health products.