BS EN ISO 10079-1:2000 pdf – Medical suction equipment Ð Part 1: Electrically powered suction equipment Ð Safety requirements.
1 Scope This part of ISO 1 0079 specifies minimum safety and performance requirements for medical and surgical suction equipment (see Figure 1 ) for health care facilities such as hospitals, for domiciliary care of patients and for field and transport use. Although such equipment may be driven by centrally powered piped vacuum systems, compressed gases and electricity, or be manually powered for a variety of applications, this part of ISO 1 0079 addresses only mains electricity- and battery-powered suction equipment. NOTE See also annex M in this part of ISO 1 0079. ISO 1 0079-1 is one of a series of International Standards based on IEC 60601 -1 :1 988; in IEC 60601 -1 (the “General Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in 1 .3 of IEC 60601 -1 :1 988, the requirements of this part of ISO 1 0079 take precedence over those of IEC 60601 -1 . The scope and object given in clause 1 of IEC 60601 -1 :1 988 apply, except that 1 .1 shall be replaced by the following: This part of ISO 1 0079 is not applicable to: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) catheter tubes, drains, curettes and suction tips; c) syringes; d) dental suction equipment; e) waste gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) passive urinary drainage; i) closed systems for wound drainage; j) gravity gastric drainage; k) orally operated mucous extractors; l) suction equipment where the collection container is downstream of the vacuum pump; m) equipment marked as suction unit for permanent tracheostomy; n) ventouse (obstetric) equipment; o) neonatal mucous extractors; p) suction equipment marked for endoscopic use only.
3 Terms and definitions For the purposes of this part of ISO 1 0079, the terms and definitions given in clause 2 of IEC 60601 -1 :1 988 apply except that the definition given in 2.1 .5 shall be replaced by the following: 2.1.5 applied part all parts in the liquid pathway Add to definition 2.4.3 the following: 2.4.3 safety extra-low voltage SELV electrical sources which are isolated (e.g. car battery) and do not require a separate transformer or converter with separate windings For the purposes of this part of ISO 1 0079, the following additional terms and definitions apply. 3.1 breast pump vacuum pump for the collection of breast milk 3.2 collection container container in which liquids and solid particles are collected 3.3 collection container assembly collection container and its closure with connectors for suction 3.4 drainage removal of fluids from a body cavity or wound 3.5 end-piece that part of the suction equipment applied to the patient which begins at the site where material is drawn in and ends at the first detachable connection NOTE Examples of commonly used end-pieces are a Yanker sucker and a suction catheter. 3.6 exhaust opening port or ports through which exhaust is discharged
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.