The No Risk STE laboratory performs safety and performance tests on electromedical equipment and health products according to the following technical standards
- IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability.
- IEC 60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- IEC 60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design.
- IEC 60601-1-10 - Medical electrical equipment - Part 1-10 - General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers.
- IEC 60601-1-11 - Medical electrical equipment - Part 1-11 - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-12 - Medical electrical equipment - Part 1-12 - Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
- IEC 60601-2-3 – Particular requirements for basic safety and essential performance of short-wave therapy equipment.
- IEC 60601-2-5 – Particular requirements for basic safety and essential performance of ultrassonic physiotherapy equipment.
- IEC 60601-2-10 – Particular requirements for basic safety and essential performance of nerve and muscle stimulators.
- ISO 80601-2-12 – Particular requirements for basic safety and essential performance of critical care ventilators.
- ISO 80601-2-13 – Particular requirements for basic safety and essential performance of an anaesthetic workstation.
- IEC 60601-2-18– Particular requirements for basic safety and essential performance of endoscopic equipment.
- IEC 60601-2-19 – Particular requirements for basic safety and essential performance of infant incubators.
- IEC 60601-2-20 – Particular requirements for basic safety and essential performance of infant transport incubators.
- IEC 60601-2-21 – Particular requirements for basic safety and essential performance of infant radiant warmers.
- IEC 60601-2-22 – Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 60601-2-23 – Particular requirements for basic safety and essential performance of transcutaneous partial pressure monitoring equipment.
- IEC 60601-2-24 – Particular requirements for basic safety and essential performance of infusion pumps and controllers.
- IEC 60601-2-25 – Particular requirements for basic safety and essential performance of electrocardiographs.
- IEC 60601-2-26 – Particular requirements for basic safety and essential performance of electroencephalographs.
- IEC 60601-2-27 – Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment.
- IEC 80601-2-30 – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
- IEC 60601-2-31 – Particular requirements for basic safety and essential performance of external cardiac pacemaker.
- IEC 60601-2-34 – Particular requirements for basic safety and essential performance of invasive blood pressure monitoring equipment.
- IEC 60601-2-35 - Particular requirements for basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use.
- IEC 60601-2-37 – Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- IEC 60601-2-39 – Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.
- IEC 60601-2-40 – Particular requirements for basic safety and essential performance of electromyographs and evoke response equipment.
- IEC 60601-2-41 – Particular requirements for basic safety and essential performance of surgical luminaries and luminaries for diagnosis.
- IEC 60601-2-46 – Particular requirements for basic safety and essential performance of operating tables.
- IEC 60601-2-47 – Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems.
- IEC 60601-2-49 – Particular requirements for basic safety and essential performance of multi function monitoring equipment.
- IEC 60601-2-50 – Particular requirements for basic safety and essential performance of infant phototherapy equipment.
- ISO 80601-2-55 – Particular requirements for basic safety and essential performance of respiratory gas monitors.
- ISO 80601-2-56 – Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- IEC 60601-2-57 – Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 80601-2-58 – Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.
- IEC 80601-2-60: – Particular requirements for basic safety and essential performance of dental equipment.
- IEC 80601-2-61 – Particular requirements for basic safety and essential performance of pulse oximeter equipment.
- IEC 60601-2-62 – Particular requirements for basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment.
- IEC 60601-2-66 – Particular requirements for basic safety and essential performance of hearing aids.
- ISO 60601-2-74 – Particular requirements for basic safety and essential performance of respiratory humidifying equipment.
- ISO 14457 – Dentistry – Handpieces and Motors.
- ISO 9680 – Dentistry - Operating lights.
- ISO 11195 – Gas mixers for medical use – Stand alone gas mixers.
- ISO 10651-4 – Lung ventilators – Part 4: Particular requirements for operator powered resuscitators.
- ISO 7494-1 – Dentistry – Dental units – Part 1: General requirements and test methods.
- ISO 7494-2 – Dentistry – Dental units – Part 2: Air, water, suction and wastewater systems.
- ISO 5356-1 – Anaesthetic and respiratory equipment – Conical connectors - Part 1 – Cones and sockets.
- ISO 5362 – Anaesthetic reservoir bags.
- ISO 5367 – Anaesthetic and respiratory equipment – Breathing sets and connectors
- ISO 10535 – Hoists for the transfer of disabled persons
- ISO 10079-1 - Medical suction equipment - Part 1: Electrically powered suction equipment.
- ISO 10079-4 - Medical suction equipment - Part 4: General requirements.
- ISO 80369-1 – Small bore connectors for liquids and gases in healthcare applications - General requirements.
- ISO 80369-5 – Small bore connectors for liquids and gases in healthcare applications - Connectors for limb cuff inflation applications.
