BS EN 1640-2009 牙科学.牙科用医疗器械.设备1.pdf
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1、 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1640 October 2009 ICS 11.060.20 Supersedes EN 1640:2004 English Version Dentistry - Medical devices for dentistry - Equipment Art dentaire - Dispositifs mdicaux pour lart dentaire - Matriel Zahnheilkunde - Medizinprodukte fr die Zahnheilkunde - A
2、usrstung This European Standard was approved by CEN on 19 September 2009. 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 alteration. Up-to-date lists and bibliogr
3、aphical references concerning such national standards may be obtained on application to the CEN 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 by translation under the responsibility of
4、a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan
5、d, 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 EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17,
6、 B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1640:2009: E EN 1640:2009 (E) 2 Contents page Foreword 3 Introduction . 4 1Scope 5 2Normative references 5 3Terms and definitions . 6 4Requirements . 6 4.1Genera
7、l 6 4.2Chemical and physical properties . 6 4.2.1Materials . 6 4.2.2Contaminants and residues 7 4.2.3Contact with substances 7 4.2.4Ingress and leaking of substances 7 4.3Control of contamination 7 4.4Construction and environmental properties . 7 4.5Protection against radiation . 7 4.6Equipment conn
8、ected to or equipped with an energy source 8 4.7Programmable electronic subsystems (software programmes) 8 4.8Protection against electrical risks . 8 4.9Protection against mechanical and thermal risks 8 4.9.1Mechanical stability . 8 4.9.2Vibration . 8 4.9.3Noise . 8 4.9.4Electricity, gas, hydraulic
9、and pneumatic energy 8 4.9.5Surface temperature 9 4.10Controls and indicators 9 4.11Clinical evaluation . 9 4.12Marking, labelling and information supplied by the manufacturer 9 4.12.1General 9 4.12.2Symbols 9 4.12.3Marking . 9 4.12.4Label 10 4.12.5Detachable components . 10 4.12.6Instructions for u
10、se . 10 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 11 Bibliography 12 EN 1640:2009 (E) 3 Foreword This document (EN 1640:2009) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which i
11、s 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 April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility
12、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 supersedes EN 1640:2004. This document has been prepared under a mandate given to CEN by the European Commissi
13、on and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. For the relationship with EU Directive 93/42/EEC, see informative Annex ZA, which is an integral part of this document. The following changes were made: a) Normative references: 1) Addition of
14、new relevant product standards, issued after 2004: EN 60601-1-4, EN 62304, EN ISO 7494-1, EN ISO 10650-1, EN ISO 10650-2, EN ISO 14155-1, EN ISO 14155-2, EN ISO 14971, EN ISO 17664, EN ISO 21530; 2) Deletion of the following withdrawn standard: EN ISO 7494. b) 4.11 Clinical evaluation: Clarification
15、 of requirement for a clinical evaluation; c) 4.12.6 Instructions for use: Clarification of requirement that information may be provided in an electronic format; d) Annex ZA: Actualisation of correspondence between this European Standard and Directive 93/42/EEC, as amended by Directive 2007/47/EC. A
16、ccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L
17、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. EN 1640:2009 (E) 4 Introduction There are three levels of European Standards dealing with medical devices used in dentistry. These are as follow
18、s: Level 1: General requirements for medical devices; Level 2: Requirements for families of medical devices used in dentistry; Level 3: Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices used in denti
19、stry. This European Standard is a level 2 standard and details requirements that apply to those items of dental equipment which are medical devices. For energy sources to be connected to dental instruments, this European Standard should be used in conjunction with EN 1639, which is applicable for de
20、ntal instruments. This European Standard also indicates that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available leve
21、l. In the Bibliography a reference for guidance on the classification of dental devices and accessories 3 is given. EN 1640:2009 (E) 5 1 Scope This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requi
22、rements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to dental X-ray equipment. This European Standard does not apply to any dental instruments connected to an item of denta
23、l equipment. These instruments are covered by EN 1639. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references,
24、 only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 1639, Dentistry Medical devic
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