SIST EN ISO 6875:2000
(Main)Dental equipment - Dental patient chair (ISO 6875:1995)
Dental equipment - Dental patient chair (ISO 6875:1995)
Applies to all dental patient chairs, regardless of their construction and also regardless of whether they are operated manually or electrically or by other means, or as a combination of these. Specifies requirements, test methods, manufacturer's information, marking and packaging. Refers to 601-1:1988, but takes priority over specifications in IEC 601-1.
Zahnärztliche Ausrüstung - Zahnärztlicher Patientenstuhl (ISO 6875:1995)
Diese Internationale Norm gilt für alle Arten von zahnärztlichen Patientenstühlen, unabhängig von ihrer Konstruktion und auch unabhängig davon, ob sie elektrisch betrieben oder kombiniert werden oder nicht. Sie legt Anforderungen, Prüfmethoden, Herstellerinformationen, Kennzeichnung und Verpackung fest.
Matériel dentaire - Fauteuil dentaire (ISO 6875:1995)
La présente Norme internationale est applicable à tous les fauteuils dentaires, quelle que soit leur construction et qu'ils fonctionnent manuellement ou électriquement ou par tout autre moyen, ou par combinaison de ces modes de fonctionnement. Elle contient des prescriptions, des méthodes d'essai, ainsi que des spécifications relatives aux informations à fournir par le fabricant, au marquage et à l'emballage.
Dental equipment - Dental patient chair (ISO 6875:1995)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dental equipment - Dental patient chair (ISO 6875:1995)Zahnärztliche Ausrüstung - Zahnärztlicher Patientenstuhl (ISO 6875:1995)Matériel dentaire - Fauteuil dentaire (ISO 6875:1995)Dental equipment - Dental patient chair (ISO 6875:1995)11.060.20Dental equipmentICS:Ta slovenski standard je istoveten z:EN ISO 6875:1996SIST EN ISO 6875:2000en01-januar-2000SIST EN ISO 6875:2000SLOVENSKI
STANDARD
SIST EN ISO 6875:2000
SIST EN ISO 6875:2000
SIST EN ISO 6875:2000
SIST EN ISO 6875:2000
SIST EN ISO 6875:2000
INTERNATIONAL STANDARD IS0 6875 Second edition 1995-02-01 Dental patient chair Fauteuil dentaire Reference number IS0 6875:1995(E) SIST EN ISO 6875:2000
IS0 6875:1995(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 6875 was prepared by Technical Committee lSO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. This second edition cancels and replaces the first edition (IS0 6875:1984), of which it constitutes a technical revision. Annex A forms an integral part of this International Standard. 0 IS0 1995 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56 l CH-1211 Geneve 20 l Switzerland Printed in Switzerland ii SIST EN ISO 6875:2000
Q IS0 IS0 6875:1995(E) Introduction This International Standard takes priority over IEC 601-I as specified in the individual clauses of this International Standard. Only the specifications laid down in this International Standard are appli- cable. This International Standard refers to IEC 601-I :I 988, the basic standard on safety of medical electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 601-I. . . . III SIST EN ISO 6875:2000
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INTERNATIONAL STANDARD 0 IS0 IS0 6875:1995(E) Dental patient chair 1 Scope the practice of dentistry and/or its associated pro- cedures. This International Standard applies to all dental patient chairs, regardless of their construction and also re- gardless of whether they are operated manually or electrically or by other means, or as a combination of these. 3.2 dental patient chair: (1) Item of d t I en a equipment, provided with a range of movements, which is designed to support and r position the patient for treatment. [ISO 1942-4:1989, It specifies requirements, test methods, manufac- definition 4.0221 turer’s information, marking and packaging. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publi- cation, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most re- cent editions of the standards indicated below. Members of IEC and IS0 maintain registers of cur- rently valid International Standards. (2) Permanently fixed or free-standing chair, adjust- able in height and posture used for supporting a pa- tient in the seated or supine position and having the means for positioning the head of the patient for dental treatment. 4 Classification This classification applies to electrically operated dental patient chairs only. 4.1 According to type of protection against electric shock IS0 8191-1:1987, Furniture - Assessment of the ignitability of upholstered furniture - Part I: Ignition source: smouldering cigarette. Dental patient chairs are classified in accordance with IEC 601-I as follows: IS0 9687:1993, Dental equipment - Graphical sym- a) Class I equipment bols. I EC 601-1: 1988, Medical electrical equipment - Part 7: General requirements for safety. 3 Definitions For the purposes of this International Standard, the definitions given in IEC 601-l and the following defi- nitions apply. Equipment in which protection against electric shock does not rely on basic insulation only, but which in- eludes an additional safety precaution in such a way that means are provided for the connection of ac- cessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot be- come live in the event of a failure of the basic insu- lation. b] Class IP equipment 3.1 dental equipment: Furniture, machines, appar- atus and accessories thereto, specially manufactured and/or presented for the use of authorized persons in Equipment in which protection against electric shock does not rely on basic insulation only, but in which 1 SIST EN ISO 6875:2000
IS0 6875:1995(E) 63 IS0 additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions. 4.2 According to degree of protection against electric shock Dental patient chairs are only of type B equipment. Type B equipment Class I or II equipment, or equipment with an internal electrical power source providing an adequate degree of protection against electric shock, particularly re- garding: - allowable leakage currents; - reliability of the protective earth connection (if present). Type B equipment is, for example, suitable for inten- tional external and internal application to the patient, excluding direct cardiac application. 4.3 According to mode of operation Dental patient chairs are a type of equipment with in- termittent operation. 5 Requirements and recommendations Electrical requirements are only applicable trically operated dental patient chairs. to elec- There are, however, general requirements in IEC 601-l referred to, which are applicable to non- electrical dental patient chairs as well. 5.1 General 5.1 .I General design 5.1.1.1 Dental patient chairs shall be designed, con- structed and manufactured so that, when properly transported, stored, installed, used and maintained according to the manufacturer’s instructions, they cause no danger which could reasonably be foreseen to the patient, to the operating personnel or to the surroundings in normal use and in single-fault con- dition. These requirements cannot be objectively assessed. They are considered as fulfilled if all following tests are passed. 5.1.1.2 Dental patient chairs shall have the strength and rigidity necessary to resist the stresses to which they may be subjected in normal dental practice without risk of introducing fire, electric shock or acci- dent hazard. These requirements cannot be objectively assessed. They are considered as fulfilled if all following tests are passed. 5.1.1.3 Any item of equipment recommended by the manufacturer for use in conjunction with the dental patient chair shall not render the chair unsafe. These requirements cannot be objectively assessed. They are considered as fulfilled if all following tests are passed. 5.1.1.4 Edges and corners of components and parts accessible to the patient or personnel shall be finished so as to avoid injury to the patient or operator. Compliance is checked by inspection. 5.1.1.5 The headrest, armrest, backrest, legrest and footrest, if provided, should be designed and con- structed in such a way that the patient can sit or lie in a relaxed position and that personnel can work in ergonomically good working positions. 5.1.1.6 Those dental patient chairs which are in- tended to be permanently fixed on the floor shall have provision for this. Testing shall be carried out in accordance with 7.1.3. 5.1.2 Moving parts Moving parts that may constitute a hazard under normal working conditions shall be covered to prevent the risk of injury to the patient and personnel. The distance between power-activated moving parts and counterparts accessible to the patient’s and per- sonnel’s hands and fingers shall be less than 10 mm when fully opened or a minimum of 20 mm when fully closed. Safety features shall be provided to protect the pa- tient and personnel from accessible power-activated moving parts. These can include safety switches, limit switches or controls requiring continuous activation. All electrical cables and hydraulic tubes shall be ad- equately protected against wear, fracture and damage due to rubbing or strain incurred during normal oper- ation of the chair. Testing shall be carried out in accordance with 7.1.4. 2 SIST EN ISO 6875:2000
0 IS0 IS0 6875:1995(E) 5.1.3 Operating controls 5.2 Mechanical Controls should be located in a position or be of such design that they cannot be accidentally activated. 5.2.1 Headrest Operating symbols according to IS0 9687 shall be used where applicable. Testing shall be carried out in accordance with 7.1.3. 5.1.4 Emergency stop system The dental patient chair shall incorporate at least one emergency stop system which is located so that it can easily be activated by the dentist and/or the op- erating personnel and which, when activated, in- stantly stops all functions which could be a hazard to the patient and the dental personnel. 52.1 .I Construction The headrest shall be capable of withstanding without failure or permanent deformation the force specified in 7.2.1 which simulates unintentional movements and the weight of the patient’s head including any additional load applied by the operator and the force imparted to the headrest by the patient due to arching of his body. Testing shall be carried out in accordance with 7.2.1. Testing shall be carried out in accordance with 7.1.3. 5.2. I .2 Releasing mechanism 5.1.5 Upholstery and padding 5.1.5.1 Material Only covering materials that lend themselves readily to cleaning and disinfection with agents rec- ommended by the manufacturer should be used. Such covering materials should be resistant to water and mercury absorption. Testing shall be carried out in accordance with 7.1.3. 5.1.5.2 Flammability The upholstery and padding shall not catch fire and resultant charring, if any, shall be not greater in length than 30 mm in any direction measured from the nearest point of the test cigarette. Testing shall be carried out in accordance with 7.1.5. 5.1.6 Cleaning and disinfection All exterior parts of the dental patient chair shall be capable of being cleaned and disinfected without de- terioration of the chair’s surface and/or markings by using agents recommended by the manufacturer. Testing 7.1 .I 1. shall be carried out in 5.1.7 Excessive temperatures IEC 601-I :I 988, clause 42 applies. accordance with Any headrest releasing mechanism should be located in such a position or be of such a design that it cannot be accidentally released or activated, but shall be ca- pable of being activated quickly when necessary. Testing shall be carried out in accordance with 7.1.3. 5.2.2 Armrests Armrests, if provided, shall be capable of withstanding without failure or permanent deformation the force specified in 7.2.2. Armrests designed to be movable horizontally or vertically shall incorporate a release mechanism or detents capable of withstanding the loads specified in 7.2.2 without their function becom- ing permanently impaired. Testing shall be carried out in accordance with 7.2.2. 5.2.3 Loading capacity 5.2.3.1 Vertical lift Dental patient chairs shall be capable of supporting and lifting a mass of at least 135 kg distributed ac- cording to table 1 plus the additional mass of dental equipment plus the accessory devices mounted on the chair as specified by the manufacturer as ad- ditional lifting capability. The chair shall not sink more than 10 mm/h. 3 SIST EN ISO 6875:2000
IS0 6875:1995(E) 0 IS0 Table 1 - Mass distribution Part of dental patient chair Head and neck Upper trunk and upper arms Mass distribution kg IO 45 Lower trunk, lower arms and hands, thighs Legs and feet Total 55 25 135 Testing shall be carried out in accordance with 7.2.3. 5.2.3.2 Tipping and stability The base edge of the dental patient chair shall not tip or lift off the ground when either loaded or unloaded during the full backrest, seat, legrest and longitudinal adjustment motions and after applying an additional mass as specified in 7.2.4. Testing shall be carried out in accordance with 7.2.4. 5.2.4 Bursting pressure A pressure system used in a dental patient chair shall be strong enough to withstand without bursting or leaking the pressures as specified in 7.2.5. Testing shall be carried out in accordance with 7.2.5. 5.2.5 Pressure relief The patient chair shall be equipped with a means for safe pressure relief for all parts in which pressure might be generated in the event of fire. Testing shall be carried out in accordance with 7.1.3 and 7.2.6. 5.2.6 Stability in normal use IEC 601-I :I 988, clause 24 applies. 5.2.7 Exceptional load due to first aid measures The patient chair shall be capable of withstanding an additional load mass of 40 kg exerted at intervals of 1 s over a duration of 1 min. 4 The patient chair shall not lift away from the floor during the test and shall not show any visible signs of damage after testing. Testing shall be carried out in accordance with 7.2.7. 5.3 Electrical 5.3.1 Failsafe device In case of a single-fault condition, e.g. failure of a limit switch, additional protective means shall be provided such as mechanical limits to prevent injury to the pa- tient or operating personnel. Testing shall be carried out in accordance with 7.3.2. 5.3.2 Power input IEC 601-I :I 988, clause 7 applies. 5.3.3 Single-fault conditions IEC 601-I :I 988, clause 3.6 applies. 5.3.4 Protection against electric shock hazards IEC 601-I :I 988, clause 13 applies. 5.3.5 Requirements related to classification 5.3.5.1 Class I equipment IEC 601-1:1988, clause 14.1 applies. 5.3.5.2 Class II equipment IEC 601-I :I 988, clause 14.2 applies. 5.3.5.3 Classes I and II equipment IEC 601-l :I 988, clause 14.4 applies, limited to classes I and II. 5.3.5.4 Type B equipment IEC 601-I :I 988, clause 14.6 applies, limited to type B. 5.3.6 Limitation of voltage and/or energy IEC 601-I :I 988, clause 15 applies. 5.3.7 Enc$losures and protective covers IEC 601-1:1988, clause 16 applies. SIST EN ISO 6875:2000
0 IS0 IS0 6875: 1995(E) 5.3.8 Spillage and ingress of liquids IEC 601-I :I 988, clauses 44.3 and 44.6 apply. 5.3.9 Leakage IEC 601-I :I 988, clause 44.4 applies. 5.3.10 IEC 60 5.3.14 Separation l-l : 1988, clause 17 applies. Protective earthing, functional earthing and potentional equalization PEC 601-I :I 988, clause 18 a) to g) applies. 5.3.12 Continuous leakage currents and patient auxiliary currents The maximum allowable values shall be as specified in table 2. Testing shall be carried out in accordance with 7.3.3. 5.3.13 Dielectric strength The dielectrical strength shall be sufficient to with- stand the test voltages specified in IEC 601-1:1988, clauses 20.1 and 20.2. Testing shall be carried out in accordance with 7.3.4. 5.3.14 Interruption of power supply 5.3.19 Construction and layout IEC 601-I : 1988, clauses 49.1 to 49.3 apply. IEC 601-I :I 988, clause 59 applies. 5.3.15 Abnormal operation and fault conditions IEC 601-I :I 988, clause 52 applies. 5.3.16 Components and general assembly IEC 601-I :I 988, clause 56.1 b) and d) applies. IEC 601-I : 1988, clauses 56.3 to 56.10 apply. IEC 601-I :I 988, clause 56.1 1 b) applies. Table 2 - Maximum allowable values of continu
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