AAMI ISO 10079-3:1999 pdf download – Medical suction equipment
4 Cleaning, disinfection and sterilization
4.1 Any filters installed shall either be of the single-use type or be capable of being cleaned, disinfected and/or sterilized for re-use.
4.2 Equipment with filters intended for re-use shall comply with the requirements given in 8.1 to 8.7, as appropriate, after the filters have been subjected to 30 cycles of sterilization as recommended by the manufacturer.
4.3 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as recommended by the manufacturer.
4.4 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements given in 8.1 to 8.7, as appropriate, before and after the collection container has been subjected to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
5.1 Collection container
5.1.1 The inlet of the collection container shall have an inside diameter of not less than 6 mm and not less than the maximum inside diameter of the suction tubing recommended by the manufacturer. The inlet shall not be compatible with any conical connector specified in ISO 5356-1 .
5.1.2 For suction equipment solely for field use which is intended to continue operating when the collection container is full, the volume of the collection container shall be not less than 200 ml. For other suction equipment intended solely for field use, the usable volume of the collection container shall be not less than 300 ml. For all other suction equipment, including suction equipment intended for field and/or transport use, the usable volume of the collection container shall be not less than 500 ml. NOTE “Field use” of suction equipment is intended to cover use in situations outside of the health care facility at the site of accidents or other emergencies. The use of suction equipment in these situations may expose the equipment to water (including rain), dirt, uneven support, mechanical shock and extremes of temperature. “Transport use” of suction equipment is intended to cover situations outside of the health care facility such as in ambulances, cars or airplanes. Use of suction equipment in these situations may expose the equipment to uneven support, dirt, mechanical shock and a wider range of temperature than normally found in health care facilities.
5.1.3 For suction equipment not intended for field use, one or more collection containers recommended by the manufacturer and either for single-use or of a re-usable type, shall be used. For all collection containers, the level of the contents shall be clearly visible in the position of normal use. The collection container shall be marked with its usable volume, expressed in millilitres. For collection containers having a capacity of 500 ml or greater, an approximate indication of the volume of the contents shall be given by graduations. The intervals of the graduation should not be less than 50 ml and not more than 250 ml.
5.1.4 The collection container shall not implode, crack or permanently deform when tested in accordance with A.2. Following this test, the suction equipment shall meet the requirements of 6.1 , 6.3 and 8.1 to 8.7, as appropriate.
5.1.5 The connectors for the suction tubing and the intermediate tubing shall be designed to facilitate correct assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be checked by inspection. NOTE Incorrect connections have frequently been a cause of spillover into the vacuum source and/or a loss of suction.