PORTAL DIGITAL M4H
A prestação de serviços médicos de forma eficiente e com qualidade requer que os equipamentos sejam seguros e fiáveis, o que por sua vez exige que a sua fabricação, bem como todo o seu ciclo de vida, seja regulada e avaliada segundo a legislação existente, normas técnicas, procedimentos internos e boas-práticas.
Assim, importa que quer os fabricantes quer os distribuidores assegurarem a conformidade dos equipamentos médicos de acordo com:
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Legislação europeia e nacional aplicável;
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Normas técnicas harmonizadas correspondentes (do CEN e CENELEC, de âmbito europeu, e, muitas vezes, da ISO e IEC, de âmbito mundial, sempre que estes organismos são os emissores do texto primário das normas), quer relativamente a sistemas de gestão da qualidade quer relativamente a produtos (grupos específicos de equipamentos médicos);
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Guias de referência em domínios transversais, como é o caso dos guias de metrologia.
O presente Portal Digital visa concentrar e disponibilizar informação diversa e considerada como a mais relevante no âmbito da temática em apreço.
Organismos de Normalização
IEC - International Electrotechnical Commission
ISO - International Organization for Standardization
CEN - European Commitee for Standardization
Comités Técnicos de Normalização
& Algumas Normas Relacionadas
IEC/TC 62 - Electrical equipment in medical practice
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-4: Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
IEC 60601-2-19: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-20: Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
IEC 60601-2-21: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-24: Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
IEC 60601-2-25: Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 80601-2-30: Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-49: Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
ISO/TC 121 - Anaesthetic and respiratory equipment
ISO 80601-2-12: Medical elétrica equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13: Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 80601-2-56: Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61: Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO/TC 198 - Sterilization of health care products
ISO 15883-1: Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-2: Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 15883-3: Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ISO 15883-4: Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 17665-2: Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
EN 285: Sterilization - Steam sterilizers - Large sterilizers
EN 13060: Small steam sterilizers
CEN/TC 204 - Sterilization of medical devices
EN 556-1: Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2: Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices