AS 16571:2015 pdf download.Systems for evacuation of plume generated by medical devices.
3.9 local stationary plume evacuation system permanently installed PES that includes a flow-generating device and terminal unit and that vents the filtered plume inside the room
3.10 manufacturer natural or legal person with responsibility for the design, manufacture, packaging, and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party
3.11 medical device any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, and intended by the manufacturer to be used for human beings for the purpose of
— diagnosis, prevention, monitoring, treatment, or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap,
— investigation, replacement, or modification of the anatomy or of a physiological process, and
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which can be assisted in its function by such means
3.12 medical supply unit permanently installed medical electrical equipment intended to supply electric power, lighting, and/or medical gases and/or liquids, plume evacuation systems, and anaesthetic gas scavenging systems to medical areas of a healthcare facility
Note 1 to entry: Medical supply units can include medical electrical equipment or medical electrical systems or parts thereof. Medical supply units can also consist of modular sections for electrical supply, lighting for therapy or illumination, communication, supply of medical gases and liquids, plume evacuation systems, and anaesthetic gas scavenging systems. Some typical examples of medical supply units are bed head services modules, ceiling pendants, beams, booms, columns, pillars, cabinetry, concealed compartments on or in a wall, and prefabricated walls.
Note 2 to entry: Detailed information about medical supply units can be found in ISO 11197.
3.13 mobile referring to transportable equipment intended to be moved from one location to anotherwhile supported by its own wheels or equivalent means
3.14 pipeline system portion of a central PES between the terminal unit(s) and the supply systemAS 16571 pdf download.