ISO 10079-2:2014 pdf free

ISO 10079-2:2014 pdf free.Medical suction equipment – Manually powered suction equipment
Manually powered suction equipment shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 14971 and which are associated with their intended application, in normal and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable risk. In that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control measures need to be determined within the risk management process to deal with such situations.Check compliance by inspection of the risk management file.
Where requirements of this part of ISO 10079 refer to freedom from unacceptable risk, the acceptability or unacceptability of this risk shall be determined by the manufacturer in accordance with their policy for determining acceptable risk. Check compliance by inspection of the risk management file.
The manufacturer may use type tests different from those detailed within this part of ISO 10079,if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test methods specified in Annex A of this part of ISO 10079.Check compliance by inspection of the technical file.
The collection container shall not implode, crack or permanently deform and shall meet the requirements of Clauses 7 and 9, as appropriate, after being subjected to a pressure of either 120 % of the manufacturer’s recommended maximum vacum level or 95 kPa below atmospheric, whichever is less, for 5 min.
Containers intended for re-use shall be tested after 30 cycles of cleaning and disinfection or sterilization as recommended by the manufacturer.
The inside diameter of the suction tubing connector (inlet port of the collection container) shall be at least 6 mm and the inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameter of the largest tubing size as specified by the manufacturer.ISO 10079-2 pdf free download.