ISO 10079-1:1999 download.Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements.
This part of ISO 10079 specifies minimum safety and performance requirements for medical and surqical 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 10079 addresses only mains electricity- and battery-powered suction equipment.
NOTE See also annex M in this part of ISO 10079.
ISO 10079-1 is one of a series of International Standards based on IEC 60601-1:1988; 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 lEG 60601-1:1988. the requirements of this part of ISO 10079 take precedence over those of IEC 60601-1.
The scope and object given in clause 1 of IEC 60601-1:1988 apply, except that 1.1 shall be replaced by the following:
This part of ISO 10079 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;
Key
1 Vacuum indicator
2 Filter
3 Collection container
4 Vacuum regulator
NOTE I This part of ISO 10079 applies to mains electricity- and battery-powered suction equipment. Part 2 of ISO 10079 applies to manually powered suction equipment. Part 3 of ISO 10079 applies to suction equipment powered from a vacuum or pressure source.
NOTE 2 Components illustrated are not necessarily required by this part of ISO 10079.
NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements and components not illuStrated.
FIgure 1 — Schematic drawing of suction equipment
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply, However, parties to agreements based on this part of ISO 10079 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources — Engineering methods for free-field conditions over a reflecting plane.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 8836:1997, Suction catheters for use in the respfratory tract.
IEC 60079-4:1975. Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition temperature.
IEC 60529:1976, Classification of degrees of protection provided by enclosures.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety; and Amd. 1:1991 and
Amd.2:1995.
IEC 60651:1979. Sound level meters.
IEC 60695-2-2:1980, Fire hazard testing — Part 2: Test methods — Needle-flame test.
3 Terms and definitions
For the purposes of this part of ISO 10079. the terms and definitions given in clause 2 of IEC 60601-1:1988 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 10079. the following additional terms and definitions apply.
breast pump
vacuum pump for the collection of breast milk
3.25
vacuum regulator
device for controlling the maximum vacuum applied to the patient
4 General requirements and general requirements for tests
The requirements given in clauses 3 and 4 of lEG 60601-1:1988 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 Sot IEC 60601-1:1988 applies.
6 Identification, marking and documents
The requirements given in clause 6 of lEG 60601-1:1988 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 1) 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.
1) All equipment generating suction shall be marked with words indicating suction, and with an ndication 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 flaw”, “high vacuum/low flow”. medium vacuum/high flow”. “medium vacuum/low flow”. “low vacuum/high flow” or low vacuum/low tlow, 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) It there is a single exhaust opening, it shall be marked with words indicating exhaust opening.
5) Suction equipment intended br 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) lithe 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 … with the appropriate limiting temperatures marked. lb 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 manufacturers recommendations.
ab) The capacity of the collection container.
In 6.3 C), add the following.