ISO 6875 pdf download

ISO 6875 pdf download Dentistry — Patient chair
6 Sampling
Where possible, all type tests shall be made on one representative sample of the patient chair.
7 Testing
7.1visual inspection
Visually inspect the test piece to determine compliance with the requirements.7.2Mechanical tests
7.2.1Moving parts
Measure the distances between the moving parts and counterparts and visually inspect the test piece todetermine compliance with the requirements.
7.2.2 Headrest construction
Use a circular metal disc of 100 mm diameter and with a radius of 15 mm at the edges.
Place the test piece in the fully reclined position with the headrest fully extended.Apply the metal disc witha force of 7,4 % of the patient mass distribution (see Table 1, head and neck) and the weight of the headrestitself, in accordance with the safety factors given in lEC 60601-1:2005,9.8.2 and lSo/IEC 80601-2-60:2011,Table 201.102.
Test in accordance with IEC 60601-1;2005,9.8 and ISO/IEC 80601-2-60:2011,9.8.2.
7.2.3Armrest
Use a circular metal disc of 100 mm diameter and with a radius of 15 mm at the edges.
Apply the metal disc to the armrest at the most critical location, with a force of 670 N vertically downwards for1 min and subsequently with a force of 440 N horizontally, in the inward and outward directions.
7.2.4 Vertical lift
Subject the test piece to a mass distributed in accordance with Table 1, plus the additional mass of equipmentmounted on the chair as specified by the manufacturer as maximum lifting capability.
Activate the test piece for three uninterrupted up-and-down movements.Then operate the test pieceintermittently three times using the control switch, performing three further complete up-and-down movements.Measure the middle position of the test piece.Leave the test piece in the middle position for 1 h. Then measurethe middle position of the test piece again and calculate the distance by which it has sunk.
7.2.5 Tipping and stability
Perform two tests with the test piece installed at its highest position on a horizontal solid flat surface inaccordance with the manufacturer’s instructions; the first test with the backrest in the upright position and thesecond test with the backrest in the supine position.
Apply a moment of 270 Nm vertically relative to the centre of gravity at any compass position (360° base circle)to a loaded and unloaded test piece (see Table 1).
When installed in accordance with the manufacturer’s instructions and with the mass distributed as specifed in Table 1, plus an additional mass for equipment mounted on the chair if specifed by the manufacturer as the maximum accessory lifting capability, no part of the base of the test piece shall tip, fail or lift off the ground when two complete cycles of the backrest are performed without interruption immediately followed by intermittent operation of the control switch on and off three times during each full half-cycle. If an additional force of 90 N in the approximate oral cavity location is applied, no part of the test piece shall tip, fail or lift off the ground during one up-and-down stroke of the chair backrest in its most extended position.
7.2.6  Pressure vessels and parts subject to pneumatic and hydraulic pressure All parts of the pneumatic system shall be tested in accordance with IEC 60601-1:2005, 9.7.5. The parts of the pneumatic and hydraulic system that are used as a support system shall be tested at all times in accordance with 9.7.5 of IEC 60601-1:2005 (disregarding the two conditions specifed in the frst paragraph of 9.7.5). Test in accordance with IEC 60601-1:2005, 9.7.
7.3  Electrical tests
7.3.1  Failsafe device On patient chairs which are power-activated and controlled by limit switches, deliberately bypass such limit switches one by one (single-fault condition). Then operate the test piece through its full range of motion to ensure that it does not result in collapse of the test piece or damage to the test piece that would be harmful to the patient sitting in it or to the operating personnel.
8  Manufacturer’s information
8.1  General
Documents shall be provided containing at least the information specifed in 8.2 and 8.3.
IEC 60601-1:2005, 7.9.1 applies.
8.2  Instructions for use
IEC 60601-1:2005, 7.9.2 applies.
8.3  Technical description
IEC 60601-1:2005, 7.9.3.1, 7.9.3.2 and 7.9.3.3 apply.
In addition, the following information shall also be provided by the manufacturer: