ISO 10079-1 pdf download – Medical suction equipment—Part 1: Electrically powered suction equipment ——Safety requirements.
1) All equipment generating suction shal 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 visle in the normal worlóng position.
NOTE Equiient ncludwig vacuum should be marked with the desatn; ‘Ngh vacuunvhgh flow”, ‘high vacuum’low flow’, rnedum vacuunvhlgh flow’, ‘medium vacuurniow flow”, low vacuum41iof flow’ or low vacui.sm’low flow, as aipropriale
2) Low vacuum equipment with a level of vacuum which Is not adustable 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 colection container shall be identified unless rnisconnection is prevented by a design feature.
7) If the suction equipment is intended for use in the field andor 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. If no case is provided, the statement shall be marked on the equçrnent.
In 6.1 add the following additional items:
as) Equipment containing a titter which is intended to be cleaned or changed by the user shall have wording clearty 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,
In 6.3 c) add the following:
It a progressive variation in the degree of vacuum is available, the direction of acustment to increase vacuum shail be clearly and permanently marked.
In 6.8.1. add the following:
The colection container capacity shall be stated in the accompanying documents. In 6.8.2 a). add the following:
The instructions for use shall additionaly include the following information:
1) instructions for operating the vacuum regulator. if supplied, and for setting the required vacuum:
2) the size and type of suction tubing recommended for use with the suction equipment and its means of connection to the collection container:
3) recommended methods for cleaning and disinfection or sterilization of all applied parts:
4) the method for removing the collection container for emptying:
5) details of the operation of any overfill protection device fitted to the collection container assembly and the usable capacity of the collection container in al the recommended inclined planes of operation;
6) if applicable, the method of controlling frothing in the collection container;
10.2 Moving parts
The requirements given in clause 22 of IEC 60601-1:1988 apply.10.3 Surfaces,corners and edges
The requirements given in clause 23 of IEC 60601-1:1988 apply.10.4 Stability in normal use
The requirements given in clause 24 of IEC 60601-1:1988 apply.10.5 Expelled parts
The requirements given in clause 25 of lEC 60601-1:1988 apply.10.6 vibration and noise
The requirements given in clause 26 of lEC 60601-1:1988 shall be replaced by the following requirements:
26.1 Low vacuum equipment (see 59.7 and 59.8)
26.1.1 ln normal use the maximum A-weighted sound pressure level (steady or peak value) of lowvacuum/low flow and low vacuum suction equipment including equipment for thoracic drainage shall notexceed 60 dB.
Compliance shall be checked by the test given in 26.1.2.
26.1.2Test the suction equipment with the inlet opened to the atmosphere and also with the inlet occluded.Place the microphone of a sound level meter complying with the requirements for a type l instrumentspecified in lEC 60651 at the position of maximum sound pressure level in the horizontal plane passingthrough the geometric centre of the suction equipment at a radius of 1 m. The measured sound pressurelevell shall not exceed the specified value.
For this test, the suction equipment shall be operated over its normal working range of flowrate including themaximum flowrate recommended by the manufacturer.Measurements shall be taken using the frequency-weighting characteristic A and the time-weighting characteristic S on the sound level meter. Themeasurements shall be taken in a free field over a reflecting plane as specified in ISO 3744.
The A-weighted background level of extraneous noise shall be at least 10 dB below that measured during the test.
ISO 10079-1 pdf download – Medical suction equipment—Part 1: Electrically powered suction equipment ——Safety requirements
