Rechercher

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is…

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in…

This document establishes the terms, definitions, methodologies, and calculations that are necessary for the recovery of waste from plastic products and materials labelled as industrially compostable (hereafter referred to as compostable plastic waste) through organic recycling. The document identifies the different types of organic recycling technologies used in the recovery and subsequent…

This document would specify requirements and recommendations for the provision of health and social care services for older persons provided by healthcare and social care personnel, irrespective of whether the service is provided in the persons own home or in a care home. The services concerned also include those offered to older people who do not reside permanently at a care home, such as…

IEC 80601-2-30:2018 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for non continuous indirect estimation of the blood pressure without arterial puncture. This document specifies requirements for the basic safety and essential performance for this ME equipment and its…

ISO 9241-171:2008 provides ergonomics guidance and specifications for the design of accessible software for use at work, in the home, in education and in public places. It covers issues associated with designing accessible software for people with the widest range of physical, sensory and cognitive abilities, including those who are temporarily disabled, and the elderly. It addresses software…

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: —   intended for use with patients who can breathe spontaneously; and —   intended for patients who would benefit from improved alveolar gas exchange; and who would…

This document defines a Universal Cybersecurity Labelling Framework for the development and implementation of cybersecurity labelling programmes for consumer IoT products and includes guidance on the following topics: • Risks and threats associated with consumer IoT products; • Stakeholders, roles and responsibilities; • Relevant standards and guidance documents; • Conformity assessment options…

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in…

This document specifies technology that supports the efficient transmission of immersive audio signals and flexible rendering for the playback of immersive audio in a wide variety of listening scenarios. These include home theatre setups with 3D loudspeaker configurations, 22.2 loudspeaker systems, automotive entertainment systems and playback over headphones connected to a tablet or smartphone.