Study Commissions

Sorry, this entry is only available in Brazilian Portuguese.

Sorry, this entry is only available in Brazilian Portuguese.

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.

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.

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).

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.

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

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.

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

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

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.

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.

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.

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.

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.

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.

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

Standardization of processes and equipment for sterilization of health products.

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

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.

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

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.