1、November 2011 Translation by DIN-Sprachendienst.English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.060.25!$v-8“1831021www.din.deDDIN EN ISO 7494-1Dentistry Dental units Part 1: General requirements and test methods (ISO 7494-1:2011)English translation of DIN EN ISO 7494-1:2011-11Zahnheilkunde Zahnrztliche Behandlungseinheiten Teil 1: Allgemeine Anforderungen und Prfverfahren (ISO 7494-1:201
3、1)Englische bersetzung von DIN EN ISO 7494-1:2011-11Mdecine bucco-dentaire Units dentaires Partie 1: Exigences gnrales et mthodes dessai (ISO 7494-1:2011)Traduction anglaise de DIN EN ISO 7494-1:2011-11SupersedesDIN EN ISO 7494-1:2005-11www.beuth.deDocument comprises pagesIn case of doubt, the Germa
4、n-language original shall be considered authoritative.1510.11DIN EN ISO 7494-1:2011-11 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat:
5、DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-05 AA Zahnrztliche Ausrstung. DIN EN ISO 7494 consists of the following parts under the general title Dentistry Dental units: Part 1: Gen
6、eral requirements and test methods Part 2: Water and air supply The DIN Standards corresponding to the International Standards referred to in the EN are as follows: Amendments This standard differs from DIN EN ISO 7494-1:2005-11 as follows: a) the requirements have been aligned with DIN EN 60601-1:2
7、007-07; b) the mass distributions for the maximum loads have been aligned with DIN EN ISO 6875; c) the requirements for the technical description and the labelling have been updated. Previous editions DIN EN ISO 7494: 1997-12 DIN EN ISO 7494-1: 2005-11 2 ISO 1942 DIN EN ISO 1942 ISO 4073 DIN EN ISO
8、4073 ISO 6875 DIN EN ISO 6875 ISO 9687 DIN EN ISO 9687 ISO 11144 DIN EN ISO 11144 ISO 21530 DIN EN ISO 21530 IEC 60601-1 DIN EN 60601-1 IEC 62353 DIN EN 62353 IEC 62366 DIN EN 62366 DIN EN ISO 7494-1:2011-11 3 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN EN
9、 ISO 4073, Dentistry Information system on the location of dental equipment in the working area of the oral health care provider DIN EN ISO 6875, Dentistry Patient chair DIN EN ISO 9687, Dental equipment Graphical symbols DIN EN ISO 11144, Dental equipment Connections for supply and waste lines DIN
10、EN ISO 21530, Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectants DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 62353, Medical electrical equipment Recurrent test an
11、d test after repair of medical electrical equipment DIN EN 62366, Medical devices Application of usability engineering to medical devices This page is intentionally blank DIN EN ISO 7494-1:2011-11 4EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7494-1 August 2011 ICS 11.060.20 Supersedes E
12、N ISO 7494-1:2005English Version Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) Mdecine bucco-dentaire - Units dentaires -Partie 1: Exigences gnrales et mthodes dessai(ISO 7494-1:2011) Zahnheilkunde - Zahnrztliche Behandlungseinheiten -Teil 1: Allgemeine A
13、nforderungen und Prfverfahren(ISO 7494-1:2011) This European Standard was approved by CEN on 14 August 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any altera
14、tion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made
15、by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia
16、, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPIS
17、CHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7494-1:2011: EContents Page Foreword 3EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 2Introduct
18、ion.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Classification .6 5 Requirements.7 6 Sampling.8 7 Testing8 8 Manufacturers instructions .9 9 Marking.10 10 Packaging.10 Bibliography11 Foreword This document (EN ISO 7494-1:2011) has been prepared by Technical Committee ISO/TC 106 “
19、Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2012, and conflicting
20、national standards shall be withdrawn at the latest by February 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document su
21、persedes EN ISO 7494-1:2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gree
22、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7494-1:2011 has been approved by CEN as a EN ISO 7494-1:2011 without a
23、ny modification. EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 3Introduction Specific qualitative and quantitative test methods for freedom from biological hazard are not included in this International Standard. However, it is recommended that, for the assessment of possible biological hazards, r
24、eference be made to ISO 10993-1. EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 41 Scope This part of ISO 7494 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered. It also specifies requirements for the manufacturers instructions, ma
25、rking and packaging. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1
26、942, Dentistry Vocabulary ISO 4073, Dentistry Information system on the location of dental equipment in the working area of the oral health care provider ISO 6875, Dentistry Patient chair ISO 9687, Dental equipment Graphical symbols ISO 11144, Dental equipment Connections for supply and waste lines
27、ISO 21530, Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectants IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 62366, Medical devices Application of usability engineeri
28、ng to medical devices IEC 62353, Medical electrical equipment Recurrent test and test after repair of medical electrical equipment IEC 80601-2-60, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment1)1) To be published. EN IS
29、O 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 53 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60601-1 and IEC 80601-2-60 and the following apply. 3.1 dental equipment furniture, machines, apparatus and accessories made for use in t
30、he practice of dentistry and/or its associated procedures NOTE Adapted from ISO 1942:2009, definition 2.68. 3.2 dental unit combination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatment ISO 1942:2009, definition
31、2.86 3.3 dental handpiece hand-held instrument used in dentistry for patient treatment, which is connected to the dental unit 3.4 high frequency surgery device HF surgery device electrosurgical device hand-held medical electrical instrument designed to transmit high frequency electrical current to b
32、iological tissue for the purpose of cutting or modifying the tissue in a surgical procedure 4 Classification 4.1 General This classification applies to electrically operated dental units only. 4.2 According to type of protection against electric shock Dental units are classified in accordance with I
33、EC 60601-1 as follows: a) Class I equipment, see IEC 60601-1:2005, 3.13. b) Class II equipment, see IEC 60601-1:2005, 3.14. 4.3 According to degree of protection against electric shock If a dental unit has an applied part, the applied part shall be grouped as Type B (see IEC 60601-1:2005, 3.132). Hi
34、gh frequency surgery devices incorporated in the dental unit are exempt from this classification. 4.4 According to mode of operation IEC 60601-1:2005, 6.6 applies. EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 65 Requirements 5.1 General Electrical requirements are only applicable to electrically
35、 operated dental units. There are, however, general requirements referred to in IEC 60601-1 which are applicable to non-electrical dental units as well. If a patient chair is an integral part of the dental unit, then ISO 6875 also applies. IEC 60601-1 and IEC 80601-2-60 apply. 5.1.1 Handpiece hoses
36、Handpiece hoses connected to the dental unit shall be disconnectable for cleaning and disinfection. The disconnectability shall be checked by manual inspection. 5.1.2 Moving parts The requirements given in IEC 60601-1:2005, 9.2 apply. Testing shall be carried out in accordance with 7.2.1. 5.1.3 Oper
37、ating controls Operating controls shall be designed and located to minimize accidental activation. Graphical symbols for operating controls shall be in accordance with ISO 9687. IEC 60601-1:2005, 15.1 applies. 5.1.4 Usability Testing shall be carried out in accordance with IEC 62366. 5.1.5 Cleaning
38、and disinfection All exterior parts, including cuspidor bowls and instrument hoses, shall be cleanable and disinfectable using agents recommended by the manufacturer without deterioration of the surface or markings. Testing shall be carried out in accordance with ISO 21530. 5.1.6 Excessive temperatu
39、res The requirements given in IEC 60601-1:2005, 11.1 apply. 5.1.7 Biocompatibility The requirements given in IEC 60601-1:2005, 11.7 apply. Compliance is checked by inspection of the information provided by the manufacturer. 5.1.8 Connections for supply and waste lines All connections shall be in acc
40、ordance with ISO 11144. EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 75.2 Mechanical requirements 5.2.1 Solids collector Dental units shall contain a solids collector in the waste system. The solids collector shall be capable of retaining solid particles with a diameter of 2 mm. Testing shall be
41、 carried out in accordance with 7.1. Measurement shall be carried out using readily available measuring instruments. 5.2.2 Amalgam separator device Dental units shall be capable of being equipped with or connected to an amalgam separator device in the waste system. Testing shall be carried out in ac
42、cordance with 7.1. 5.2.3 Bursting pressure Pressure systems used in dental units shall be strong enough to withstand, without bursting or leaking, the pressures specified in 7.2.2. Testing shall be carried out in accordance with 7.2.2. 5.3 Electrical requirements IEC 60601-1 and IEC 80601-2-60 apply
43、. 5.3.1 Failsafe device In case of a single-fault condition, e.g. failure of a limit switch, additional protective means (failsafe device) shall be provided. EXAMPLE Mechanical limits to prevent injury to the patient and/or operating personnel. Testing shall be carried out in accordance with 7.3.1.
44、5.3.2 Test point In order to perform the service requirement specified in IEC 62353, the dental unit shall have a connector/plug for the power supply. Testing shall be carried out in accordance with 7.1. 6 Sampling Where possible, all type tests shall be made on one representative sample of the dent
45、al unit being tested. 7 Testing 7.1 Visual inspection Visually inspect the equipment to determine compliance with the requirements. EN ISO 7494-1:2011 (E) DIN EN ISO 7494-1:2011-11 87.2 Mechanical tests 7.2.1 Moving parts Measure the distances between the moving parts and counterparts and visually i
46、nspect the equipment to determine compliance with the requirements. 7.2.2 Pressure vessels and parts subject to pneumatic and hydraulic pressure Test in accordance with IEC 60601-1:2005, 9.7. 7.3 Electrical tests IEC 60601-1 and IEC 80601-2-60 apply. 7.3.1 Failsafe device On dental units which are p
47、ower-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
48、 to the patient or to the operating personnel. 8 Manufacturers instructions 8.1 General Documents shall be provided containing at least the information specified in 8.2 to 8.3. IEC 60601-1: 2005, 7.9.1 applies. 8.2 Instructions for use IEC 60601-1: 2005, 7.9.2 applies. In addition, the full range of
49、 motion shall be quoted. If mounting equipment for other manufacturers attachments is provided, the manufacturer shall stipulate the maximum loading capabilities for those attachments in the instructions for use included with each dental unit. 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: a) overall dimensions of the dental unit; b) overall dimensions of the baseplate and s
