The ISO 80601 standard, developed by the International Standards Organization (ISO), consists of the following sections under the main title of "Medical electrical equipment":
The ISO 80601-2-12 standard applies to the essential safety and performance of a ventilator intended for use in a specialized care setting for patients who may be life-threatening and may require extensive care and ongoing monitoring in a professional healthcare facility.
The ISO 80601-2-13 standard applies to the basic safety and performance of an anesthetic workstation for administering inhalation anesthesia while constantly under the supervision of a professional operator. This standard covers the specific requirements for a complete anesthetic workstation and the following anesthetic workstation components, which are considered separate devices in their own right, but are used in conjunction with other relevant anesthetic workstation components: anesthetic gas delivery system, anesthetic breathing system, anesthetic gas cleaning system , anesthetic vapor delivery system, anesthetic ventilator, imaging equipment, alarm system and protection device.
The ISO 80601-2-26 standard applies to the basic safety and performance of electroencephalographs. This standard applies to electroencephalographs intended for use in a professional healthcare facility, emergency medical services setting, or home healthcare setting.
The ISO 80601-2-30 standard applies to the basic safety and performance of automatic blood pressure monitors used via an inflatable cuff for non-continuous indirect estimation of blood pressure without arterial puncture. This standard specifies the essential safety and performance requirements of the medical equipment in question.
The ISO 80601-2-35 standard specifies the specific basic safety and performance requirements for heating devices using blankets, pads or mattresses for heating in medical use, which minimizes hazards to patients and operators, and provides test methods that demonstrate compliance with these requirements.
The ISO 80601-2-49 standard applies to the basic safety and performance requirements of multifunctional patient monitors. This standard applies to multifunctional patient monitors intended for use in professional healthcare facilities, as well as in an emergency medical service environment or home healthcare environment.
The ISO 80601-2-55 standard specifies specific requirements for the essential safety and performance of a respiratory gas monitor intended for continuous use with a patient.
The ISO 80601-2-56 standard, with its accessories, applies to the basic safety and performance of a clinical thermometer. This standard specifies general and technical requirements for electrical clinical thermometers. This standard applies to all electrical clinical thermometers used to measure the body temperature of patients.
The ISO 80601-2-58 standard applies to the essential safety and performance of lens removal devices and vitrectomy devices for ophthalmic surgery and related accessories that can be connected to this medical electrical equipment.
The ISO 80601-2-59 standard applies to the basic safety and performance of scanning thermographs intended for use for individual non-invasive febrile temperature screening of a human under controlled environmental conditions. This standard specifies laboratory characterization test limits for scanning thermography.
The ISO 80601-2-60 standard applies to the essential safety and performance of dental units, dental patient chairs, dental handpieces and dental operating lamps.
The ISO 80601-2-61 standard applies to the essential safety and performance of pulse oximetry equipment intended for human use. This standard covers all parts required for normal use, including the pulse oximetry monitor, pulse oximetry probe, and probe cable extender.
The ISO 80601-2-67 standard applies to the essential safety and performance of oxygen protective equipment when used in the home, with accessories intended to maintain supplemental oxygen by intermittent and synchronized gassing with the patient's inspiratory cycle.
The ISO 80601-2-69 standard specifies the requirements for the essential safety and performance of an oxygen concentrator with its accessories aimed at increasing the oxygen concentration of the gas intended to be delivered to a single patient. Such oxygen concentrators are typically designed for use in a home healthcare setting by a single patient in a variety of settings, including commercial aircraft as well as any private and public transport.
The ISO 80601-2-70 standard applies to the essential safety and performance of sleep apnea respiratory therapy equipment aimed at relieving the symptoms of patients suffering from obstructive sleep apnea by applying a therapeutic respiratory pressure to the airways.
The ISO 80601-2-71 standard specifies a process for a manufacturer to analyze, determine, develop and evaluate the usability of a medical equipment with respect to safety. This process allows the manufacturer to assess and reduce the risks associated with correct use and handling errors, i.e. normal use.
The ISO 80601-2-72 standard, with its accessories, applies to the essential safety and performance of a ventilator intended for use in a home healthcare environment or intended for use by a casual operator, intended for use with patients dependent on mechanical ventilation for life support.
The ISO 80601-2-74 standard applies to the basic safety and performance of a humidifier with its accessories. It can also be applied to accessories that are intended by the manufacturer to be connected to the humidifier and where the characteristics of these accessories may affect the basic safety or basic performance of the humidifier.
The ISO 80601-2-77 standard applies to the basic safety and performance of robotic-assisted surgical equipment and robotic-assisted surgery systems.
The ISO 80601-2-78 standard contains requirements for the essential safety and performance of medical robots that physically interact with a patient with a disability to support or perform rehabilitation, assessment or mildness related to the patient's movement functions.
The ISO 80601-2-79 standard applies to the essential safety and performance of ventilator support equipment intended for use in a home healthcare setting for impaired ventilation, intended for use by a casual operator, or designed for use on patients with respiratory failure.
The ISO 80601-2-80 standard applies to the essential safety and performance of respiratory support equipment intended for use in a home healthcare environment, intended for use by a casual operator, intended for use in patients with ventilator failure or insufficiency, and intended for use in transit operable.
The ISO 80601-2-84 standard applies to the essential safety and performance of an EMS ventilator, with its accessories intended for use in the EMS environment, intended for use by a healthcare professional, and designed for invasive or non-invasive ventilation.
The ISO 80601-2-85 standard applies to the basic safety and performance of cerebral tissue oximetry equipment that uses light of multiple wavelengths to obtain a quantitative measure of the oxygen saturation of hemoglobin within the volume of tissue sampled under the head-worn probe.
The ISO 80601-2-87 standard applies to the essential safety and performance of a high frequency ventilator intended for use in a specialized care environment for patients who may be life threatening and may require extensive care and ongoing monitoring in a professional healthcare facility.
The ISO 80601-2-90 standard applies to the essential safety and performance of respiratory high-flow therapy equipment designed for use in spontaneously breathing patients and patients who will benefit from improved alveolar gas exchange.
Among the numerous tests, measurements, analyses, and evaluations our organization provides for businesses in various sectors, we also offer testing services for medical electrical equipment under the ISO 80601 standard, utilizing a trained and expert staff and advanced technological equipment.
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