EUROLAB laboratory provides testing and compliance services within the scope of ISO 80601-2-70 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 80601 standard applies to the essential safety and essential performance of sleep apnea respiratory therapy equipment, hereinafter referred to as ME equipment, which aims to alleviate the symptoms of patients suffering from obstructive sleep apnea by applying a therapeutic respiratory pressure to the airways.
Sleep apnea respiratory therapy equipment is designed for use in a home healthcare setting by casual operators as well as in professional healthcare settings.
Sleep apnea respiratory therapy equipment is not considered to use a physiological closed-loop control system unless it uses a physiological patient variable to adjust therapy settings.
Sleep apnea is a chronic medical condition in which the patient repeatedly stops breathing during sleep. These attacks typically last 10 seconds or longer and cause blood oxygen levels to drop. It can be caused by an upper airway obstruction (obstructive sleep apnea or OSA) or by the brain's inability to initiate a breath (central sleep apnea).
This document does not cover sleep apnea respiratory therapy equipment intended for use in neonates. This document applies to ME equipment or ME system for patients not dependent on mechanical ventilation.
This document does not apply to ME equipment or ME system for patients dependent on mechanical ventilation, such as patients with central sleep apnea.
This document also applies to accessories that are intended by their manufacturers to be connected to sleep apnea respiratory therapy equipment and where the characteristics of these accessories may affect the essential safety or essential performance of sleep apnea respiratory therapy equipment.
Masks and application accessories intended for use during respiratory therapy for sleep apnea are additionally addressed by ISO 17510.
If an article or sub-article is specifically intended to be applicable to ME equipment only or ME systems only, the title and content of that article or sub-article shall say so. If this is not the case, the item or sub-clause applies to both ME equipment and ME systems as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems covered by this document are not covered by the specific requirements in this document, apart from the general standard.
This standard does not apply to high frequency jet ventilators (HFJVs) or high frequency oscillating ventilators (HFOVs) given in ISO 80601-2-87.
This standard does not specify the requirements given in ISO 80601‑2 for ventilators or accessories for critical care ventilators for ventilator-dependent patients. It does not specify requirements for ventilators or accessories for anesthetic applications given in ISO 80601-2-13.
This standard does not specify requirements for ventilators or accessories for home care ventilators for ventilator-dependent patients given in ISO 80601-2-72.
It also does not specify requirements for emergency and transport ventilators or accessories given in ISO 80601-2-84. This standard does not specify requirements for ventilators or accessories for home care ventilator support provided in ISO 80601-2-79 and ISO 80601‑2‑80.
EUROLAB assists manufacturers with ISO 80601-2-70 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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