ISO 10079-1:1999 pdf download – Medical suction equipment —Part 1: Electrically powered suction equipment——Safety requirements.
1) Al equipment generating suction shall be marked with words mdicating suction, and with an indication of the available level of vacuum as determined by the manufacturer. This marking shall be visible in the normal wodring position.
NOTE Ecuipment induding vacuum should be marked with the designation; high vacuum.high flow. •tiigh vacuumlow ttow, medium vacuurntHgh tlow. niedlum vacuurrhIow ftow. low vacuumhgh flow’ or low vaajumtow ttow, as appropriate.
2) Low vacuum equipment with a level of vacuum which is not adjustable by the user shall be marked either with the level of vacuum which can be attained or with words indicating low vacuum.
3) Intermittent suction equipment shall be marked with words indicating intermittent suction. Equipment which can provide both continuous and intermittent suction shall have the mode control clearly marked.
4) If there is a single exhaust opening, it shall be marked with words indicating exhaust opening.
5) Suction equipment intended for thoracic drainage and complying with 59.8 shall be marked as such.
6) The inlet connection to the collection container shall be identified unless rnisconnection is prevented by a design feature.
7) If the suction equipment is Intended for use in the field and/or transport and does not comply wIth 53.1, It shall be marked on the equipment case as nof suitable for use at temperatures below … C or above .. °C. with the appropriate limiting temperatures marked. It no case is provided, the statement shall be marked on the equipment.
In 6.1, add the following additional items:
aa) Equnient containing a filter which is intended to be cleaned or changed by the user shal have wording clearly marked on the equqmenl, or on the fifler unit, to the effect that the Pilfer should be cleaned or changed in accordance with the manufacturers recommendations.
ab) The capacity of the collection container.
In 6.3 C), add the following:
If a progressive variation In the degree of vacuum Is available, the direction of adjustment to Increase vacuum shall be clearly and permanently marked.
In 6.8.1. add the following:
The collection container capacity shal be stated in the accompanying documents. In 6.8.2 a). add the following:
The instructions for use shall additionally include the following information:
1) instructIons for operating the vacuum regulator, if supplied, and for setting the required vacuum:
2) the size and type of suction tubing recommended for use with the suction equment and its means of connection to the collection container:
3) recommended methods for cleaning and disinfection or sterilization of all applied parts;
4) the method for removing the collection container for emptying;
5) details of the operation of any overfill protection device fitted to the collection container assembly and the usable capacity of the collection container in all the recommended inclined planes of operation;
6) if applicable, the method of controlling frothing In the collection container;
1) Al equipment generating suction shall be marked with words mdicating suction, and with an indication of the available level of vacuum as determined by the manufacturer. This marking shall be visible in the normal wodring position.
NOTE Ecuipment induding vacuum should be marked with the designation; high vacuum.high flow. •tiigh vacuumlow ttow, medium vacuurntHgh tlow. niedlum vacuurrhIow ftow. low vacuumhgh flow’ or low vaajumtow ttow, as appropriate.
2) Low vacuum equipment with a level of vacuum which is not adjustable by the user shall be marked either with the level of vacuum which can be attained or with words indicating low vacuum.
3) Intermittent suction equipment shall be marked with words indicating intermittent suction. Equipment which can provide both continuous and intermittent suction shall have the mode control clearly marked.
4) If there is a single exhaust opening, it shall be marked with words indicating exhaust opening.
5) Suction equipment intended for thoracic drainage and complying with 59.8 shall be marked as such.
6) The inlet connection to the collection container shall be identified unless rnisconnection is prevented by a design feature.
7) If the suction equipment is Intended for use in the field and/or transport and does not comply wIth 53.1, It shall be marked on the equipment case as nof suitable for use at temperatures below … C or above .. °C. with the appropriate limiting temperatures marked. It no case is provided, the statement shall be marked on the equipment.