AS 16571:2015 pdf free
AS 16571:2015 pdf free.Systems for evacuation of plume generated by medical devices (ISO 16571:2014, MOD)
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
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
一diagnosis, prevention, monitoring, treatment, or alleviation of disease,
一diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap,
一investigation, replacement, or modification of the anatomy or of a physiological process, and
一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 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.AS 16571 pdf free download.
