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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1640 : 1997 The Eur
2、opean Standard EN 1640 : 1996 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dentistry Medical devices for dentistry Equipment Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy,
3、 (c) BSI BS EN 1640 : 1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 March 1997 BSI 1997 The following BSI references relate to the work on this stan
4、dard: Committee reference CH/60 Draft for comment 94/508361 DC ISBN 0 580 27140 4 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/60, Dental equipment, upon
5、 which the following bodies were represented: Association of British Health-care Industries British Dental Association British Dental Trade Association British Society for Restorative Dentistry Department of Health Institute of Physics Water Research Centre Licensed Copy: sheffieldun sheffieldun, na
6、, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1640 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Specification Foreword2 1Scope3 2Normative references3 3Definitions3 4Requirements3 Annexes A(informative) Bibliography6 ZA(informat
7、ive) Clauses of this British Standard addressing essential requirements or other provisions of EU Directives6 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1640 : 1997 National foreword This British Standard has been prep
8、ared by Technical Committee CH/60 and is the English language version of EN 1640 : 1996 Dentistry Medical devices for dentistry Equipment, published by the European Committee for Standardization (CEN). Cross-references Publication referred toCorresponding British Standard EN 980BS EN 980 : 1997 Grap
9、hical symbols for use in the labelling of medical devices EN 21942-1 BS EN 21942 Dental vocabulary Part 1 : 1992 General and clinical terms EN 21942-4Part 4 : 1994 Dental equipment EN 28601BS EN 28601 : 1992 Specification for representation of dates and times in information interchange EN 60601-1BS
10、EN 60601 Medical electrical equipment Part 1: General requirements for safety EN 60825BS EN 60825 (series) Safety of laser products EN ISO 7488BS EN ISO 7488 : 1996 Dental amalgamators EN ISO 9680BS EN ISO 9680 : 1996 Specification for dental operating light EN ISO 9687BS EN ISO 9687 : 1996 Dental e
11、quipment Graphical symbols Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, and inside front cover, pages i and ii, the EN title page, pages 2 to 8, an inside back cover and a back cover. Licensed Co
12、py: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN memb
13、ers Ref. No. EN 1640 : 1996 E EUROPEAN STANDARDEN 1640 NORME EUROPE ENNE EUROPA ISCHE NORM August 1996 ICS 11.060.20 Descriptors: Dentistry, dental equipment, specifications, information, labelling, technical notes English version Dentistry Medical devices for dentistry Equipment Art dentaire Dispos
14、itifs me dicaux pour lart dentaire Mate riel Zahnheilkunde Medizinprodukte fu r die Zahnheilkunde Ausru stung This European Standard was approved by CEN on 1996-07-04. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European St
15、andard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, Frenc
16、h, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, Fr
17、ance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 1640 : 1996 BSI 1997 Foreword This European S
18、tandard has been prepared by Technical Committee CEN/TC 55, Dentistry, the secretariat of which is held by DIN. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directiv
19、e(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. 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 1997, and conflicting na
20、tional standards shall be withdrawn at the latest by February 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland,
21、Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows: level 1: general requirements for medical devices; level 2: particular requirement
22、s 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 dentistry. This standard is a level 2 standard and details requirements that ap
23、ply to those items of dental equipment which are medical devices. For energy sources to be connected to dental instruments, this standard should be used in conjunction with EN 1639, which is applicable for dental instruments. This standard also indicates that there are additional requirements in the
24、 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 level. In the informative annex A a reference for guidance on the classification of medical devices used
25、in dentistry 3 is given. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1640 : 1996 BSI 1997 1 Scope This European Standard specifies general requirements for items of dental equipment used in the practice of dentistry and which a
26、re medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer. This standard does not include requirements for dental X-ray equipment. This standard does not apply to any dental instru
27、ments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate. 2 Normative references This European Standard incor
28、porates by dated or undated references provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this Euro
29、pean Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 980Graphical symbols for use in the labelling of medical devices prEN 1041Information supplied by the manufacturer with medical devices EN 1639Den
30、tistry Medical devices for dentistry Instruments EN 21942-1Dental vocabulary Part 1: General and clinical terms EN 21942-4Dental vocabulary Part 4: Dental equipment EN 28601Data elements and interchange formats Information interchange Representation of dates and times EN 60601-1Medical electrical eq
31、uipment Part 1: General requirements for safety EN 60825Radiation safety of laser products, equipment, classification, requirements and users guide prEN ISO 6875Dental patient chair EN ISO 7488Dental amalgamators ISO 7494Dental unit EN ISO 9680Dental operating light EN ISO 9687Dental equipment Graph
32、ical symbols ISO/DIS 11498Dental handpieces Dental low voltage motors prEN ISO 13294 Dental air motors 3 Definitions For the purposes of this standard the definitions of EN 21942-1 and EN 21942-4 apply. dental equipment Furniture, machines, apparatus and accessories thereto, specially manufactured a
33、nd/or presented for the use of authorized persons in the practice of dentistry and/or its associated procedures. EN 21942-1 : 1991 4 Requirements 4.1 General 4.1.1 Dental equipment shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the equipment c
34、oncerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the following subclauses, if appropriate. 4.1.2 For those items of dental equipment intended to be used in connection with dental instruments, this standard and EN 1639 shall apply, if appropr
35、iate. 4.1.3 Dental equipment used in accordance with the instructions for use shall be safe for its intended purpose in the practice of dentistry. 4.1.4 For dental equipment a risk analysis shall be carried out and documented. NOTE. EN 1441 describes a procedure for carrying out and documenting a ri
36、sk analysis of medical devices. 4.2 Chemical and physical properties 4.2.1 Materials Dental equipment shall comply with the material requirements as specified in the following product standards, if appropriate: prEN ISO 6875, ISO 7494, EN ISO 9680. 4.2.2 Contaminants and residues Dental equipment sh
37、all be designed and manufactured so that the transfer of contaminants and residues to the patient and the dental personnel is minimized. Design specifications are given in the product standards. The following standards shall apply, if appropriate: prEN 6875, ISO 7494, ISO/DIS 11498, prEN ISO 13294.
38、4.2.3 Contact with substances Dental equipment shall satisfy the performance requirements for safe use with water, gases, oil, and other substances with which it enters into contact during normal use. The following standards shall apply, if appropriate: prEN ISO 6875, ISO 7494, EN ISO 9680, ISO/DIS
39、11498, prEN ISO 13294. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1640 : 1996 BSI 1997 4.2.4 Ingress and leaking of substances Dental equipment shall be safe in regard to any risks due to ingress or leakage or both of water, g
40、ases, oil, and other substances during normal use. The following standards shall apply, if appropriate: EN 60601-1, prEN ISO 6875, EN ISO 7488, ISO 7494, EN ISO 9680. 4.3 Control of contamination Dental equipment shall be designed and manufactured so as to facilitate infection control. 4.4 Construct
41、ion and environmental properties 4.4.1 Dental equipment shall be designed and manufactured so that its physical and dimensional characteristics are suitable for its intended use and its use in combination according to the instructions for use. Connections to other devices shall be safe and create no
42、 risk due to physical features such as pressure or temperature or by accidental disconnection. The following standards shall apply, if appropriate: EN 60601-1, prEN ISO 6875, ISO 7494, EN ISO 9680, ISO/DIS 11498, prEN ISO 13294. 4.4.2 Dental equipment shall be designed and manufactured so that fire
43、or explosion due to the use of any other substance shall be avoided. The following standards shall apply, if appropriate: prEN ISO 6875, ISO 7494, EN ISO 9680. 4.5 Protection against radiation 4.5.1 Dental equipment emitting radiation shall be accompanied by detailed instructions which inform about
44、the safe installation, use and possible risks of the equipment. The following standards shall apply, if appropriate: EN 60601-1, EN 60825, EN ISO 9680. 4.5.2 Dental equipment shall be designed and manufactured so that unintended radiation is reduced as far as possible. 4.6 Equipment connected to or
45、equipped with an energy source Dental equipment, internally or externally equipped with or connected to a power source and/or controlled by electronic programmable systems or both, shall be designed and manufactured to minimize the risk of personal injury during normal use. If the safety of the pati
46、ent depends on the correct functioning of the equipment, an adequate alarm system or means of determining the state of the energy supply or both shall be installed. The following standards shall apply, if appropriate: EN 60601-1, EN ISO 9680, prEN ISO 6875, ISO 7494, ISO/DIS 11498, prEN ISO 13294. 4
47、.7 Protection against electrical risks Dental equipment, internally or externally equipped with or connected to an electrical power source or both, shall be safe so as to avoid as far as possible the risk of electrical shock during normal use and under single fault conditions. The following standard
48、s shall apply, if appropriate: EN 60601-1, EN 60825, prEN ISO 6875, ISO 7494, EN ISO 9680, ISO/DIS 11498, prEN ISO 13294. 4.8 Protection against mechanical and thermal risks 4.8.1 Mechanical stability Dental equipment shall be designed and manufactured to remain stable under normal conditions of use
49、. The safe load and distribution of any accessory shall be specified. No moving part shall constitute a risk to the patient or dental personnel. The following standards shall apply, if appropriate: prEN ISO 6875, ISO 7494, EN ISO 9680. 4.8.2 Vibration Dental equipment shall be designed and manufactured to minimize the risk of personal injury from vibration. The following standards shall apply, if appropriate: ISO/DIS 11498, prEN ISO 13294. 4.8.3 Noise Dental equipment shall be designed and manufactured to minimize the risk o
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