AAMI ISO 10079-2 pdf free download

AAMI ISO 10079-2 pdf free download.Medical Suction Equipment—Part 2: Manually Powered Suction Equipment.
3 Terms and definitions For the purposes of this part of ISO 1 0079, the terms and definitions given in ISO 1 0079-1 and the following apply. 3.1 manually powered vacuum manually generated vacuum generation of vacuum by human effort with a hand or foot or both 3.2 transportable equipment equipment which is intended to be easily moved from one place to another, whether or not connected to the vacuum supply, without an appreciable restriction of range 4 Cleaning and sterilization 4.1 The suction equipment shall meet the requirements given in 8.1 to 8.3 after those components which are subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer. 4.2 Any filters installed shall either be of the disposable type or be capable of being cleaned, disinfected and/or sterilized for re-use in accordance with 4.1 . 4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer. 4.4 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as recommended by the manufacturer.5 Design requirements NOTE The constructional requirements may deviate from those detailed in this part of ISO 1 0079 if the equivalent level of safety is obtained. 5.1 Connectors 5.1.1 Collection container connectors The connectors for the suction tubing and the intermediate tubing to the vacuum source shall be designed to facilitate correct assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be checked by inspection. The construction of the connections has frequently been a source of spillover into a vacuum pump. The use of mechanical fittings so as to ensure correct attachment is highly desirable. 5.1.2 Inside diameter of suction tubing connection 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 recommended by the manufacturer. 5.1.3 Exhaust opening It shall not be possible to connect suction tubing to the exhaust opening.5.2 Suction tubing 5.2.1 General If supplied, suction tubing shall have an inside diameter of not less than 6 mm. Suction performance may be markedly affected by the length, diameter and degree of collapse of the suction tubing. When tested in accordance with A.2, the degree of collapse of the suction tubing supplied with the equipment shall be less than 0,5 throughout its entire length. 5.2.2 Length of suction tubing for foot-operated suction equipment When the foot-operated vacuum pump is on the floor in the operating position, the length of suction tubing, if supplied, shall be such that the endpiece can be positioned at least 1 ,3 m above the floor. NOTE See also annex C for rationale.5.3 End-pieces Suction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836. 6 Operational requirements 6.1 Ease of operation The suction equipment shall be designed to be operated by one person unaided. 6.2 Dismantling and reassembly Suction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed to facilitate correct assembly or marked to indicate correct reassembly when all parts are mated. After dismantling, reassembly and testing in accordance with the manufacturer’s instructions, the suction equipment shall meet the requirements given in 8.1 to 8.3, as appropriate.AAMI ISO 10079-2 pdf download.