M4H DIGITAL PORTAL
The provision of medical services efficiently and with quality requires that equipment be safe and reliable, which in turn requires that its manufacture, as well as its entire life cycle, be regulated and evaluated according to existing legislation, standards techniques, internal procedures and good practices.
Therefore, it is important that both manufacturers and distributors ensure the compliance of medical equipment in accordance with:
Applicable European and national legislation;
Corresponding harmonized technical standards (from CEN and CENELEC, at European level, and often from ISO and IEC, at world level, whenever these bodies issue the primary text of the standards), or regarding quality management systems or in relation to products (specific groups of medical equipment);
Reference guides in transversal domains, such as metrology guides.
This Digital Portal aims to concentrate and make available diverse information considered to be the most relevant within the scope of the subject in question.
Standardization Bodies
IEC - International Electrotechnical Commission
ISO - International Organization for Standardization
CEN - European Committee for Standardization
Technical Commissions
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 electrical 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