BS EN ISO 10079-1 pdf free download

BS EN ISO 10079-1 pdf free download.Medical suction equipment – Part 1: Electrically powered suction equipment – Safety requirements.
4 General requirements and general requirements for tests The requirements given in clauses 3 and 4 of IEC 60601 -1 :1 988 apply, together with the following additional item: 4.6 f) Where reference is made in test methods to tubing, the tubing which is supplied or recommended by the manufacturer shall be used. 5 Classification The classification given in clause 5 of IEC 60601 -1 :1 988 applies. 6 Identification, marking and documents The requirements given in clause 6 of IEC 60601 -1 :1 988 apply, with the following additions and modifications: 6.1 e) add the following: The address of the manufacturer, and the name and address of the supplier responsible within the region or country if the supplier is not the manufacturer. Wherever reasonable and practicable, the device and detachable components shall be identified, where appropriate, in terms of batches, to allow the appropriate action to detect any potential risk posed by the devices and detachable components. 6.1 f) add the following: The equipment shall be marked with a batch or serial number and also year of manufacture, to allow all parts in the functional state to be sufficiently identified to the level that appropriate action can be undertaken if a defect or hazard arises. Replace 6.1 p) by the following:1 ) All equipment generating suction shall be marked with words indicating suction, and with an indication of the available level of vacuum as determined by the manufacturer. This marking shall be visible in the normal working position. NOTE Equipment including vacuum should be marked with the designation; “high vacuum/high flow”, “high vacuum/low flow”, “medium vacuum/high flow”, “medium vacuum/low flow”, “low vacuum/high flow” or “low vacuum/low flow”, 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 misconnection 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 not suitable for use at temperatures below … °C or above … °C, with the appropriate limiting temperatures marked. If no case is provided, the statement shall be marked on the equipment. In 6.1, add the following additional items: aa) Equipment containing a filter which is intended to be cleaned or changed by the user shall have wording clearly marked on the equipment, or on the filter unit, to the effect that the filter should be cleaned or changed in accordance with the manufacturer’s recommendations. ab) The capacity of the collection container.BS EN ISO 10079-1  pdf download.