ISO 10079-3:2014 pdf free
ISO 10079-3:2014 pdf free.Medical suction equipment一Suction equipment powered from a vacuum or positive pressure gas source
The following information shall be permanently and legibly marked on the suction equipment, or on parts of it, where applicable:
a) the name or trade name and address of the manufacturer and, in addition, the name and address of the authorized representative where applicable;
b) details necessary for the user to identify the device and the contents of the packaging;
c) the word”sterile”;
d) batch code preceded by the word “LOT”, or serial number;
e) an indication of the date by which the device, or parts thereof, can be used in safety, expressed as the year and month;
f) an indication that the device, or parts thereof, are for single use (manufacturer’s indication of single use shall be consistent);
g) words indicating “exhaust” on the exhaust port, if a single opening is provided. A single opening may allow a misconnection and should be labelled; a multiple hole exhaust system is unlikely to be misconnected;
h) words indicating “inlet” at the connection to the collection container, unless misconnection is prevented by a design feature;
i) for collection containers having a capacity of 500 ml or greater, the usable volume, expressed in millilitres, and graduations with intervals not less than 50 ml and not more than 250 ml;
j) all equipment generating suction shall be marked with words indicating suction. This marking shall be visible in the normal working position;
k) an indication that the equipment is intended for pharyngeal suction only;
l) if the suction equipment is intended for use in the field and/or transport, it shall be marked on the equipment case as not suitable for use at ambient temperatures below … or above … If no case is provided, the statements shall be marked on the equipment;
m) for suction equipment intended for thoracic drainage, words indicating “thoracic drainage”;
n) the maximum vacuum level for which the equipment is designed shall be marked prominently on the display case or immediately adjacent to it;
o) suction equipment having a vacuum regulator with a variable control shall have a vacuum level indicator displaying the vacuum level on the inlet side of the vacuum regulator. The units of measurement shall be marked prominently on the display case or immediately adjacent to it;ISO 10079-3 pdf download.
