EN ISO 10637-2000 en Dental Equipment - High- and Medium-Volume Suction Systems《牙科设备 高和中容量抽吸系统 ISO 10637-1999》.pdf

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1、I BS EN IS0 STD.BSI ES EN IS0 LOb37-ENGL 2000 9 Lb24bb 0882279 7Lb BRITISH STANDARD 10637:2000 Dental equipment - High- and medium- volume suction systems The European Standard EN Is0 106372000 has the status of a British Stancard ICs 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED B

2、Y COPYRIGHT LAW STD.BS1 BS EN IS0 LOb37-ENGL 2000 IB Lb24bb 0882280 438 BS EN IS0 10637:2000 direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 Amd.No. O BSI 12-2000 National foreword Date C

3、omments This British Standard is the officiai English language version of EN IS0 106372000. It is identical with IS0 106371999. The UK participation in its preparation was entrusted to Technical Committee CW60, Dental equipment, which has the responsibility to: - aid enquirers to understand the text

4、; - present to the responsible inkdonaVEuropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; - monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee c

5、an be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement in

6、ternational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index“, or by using the “Find“ facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to i

7、nclude all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, th

8、e EN IS0 title page, the EN IS0 foreword page, the IS0 title page, pages ii to iv, pages 1 to 18, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. ISBN O 580 36596 4 I I STD-BSI BS EN IS0 30637-ENGL 2000 II 1629669 0

9、882281 379 EUROPEAN STANDARD EN IS0 10637 NORME EUROPENNE EUROPISCHE NORM October 2000 ICs 1 1.060.20 English version Dental equipment - High- and medium-volume suction systems (I SO 1 0637: 1 999) Matriel dentaire - Systmes daspiration haut et moyen volume (IS0 10637:1999) Zahnrztliche Ausrstungen

10、- Absaugsysteme mit hoher und mittlerer Durchflumenge (IS0 10637:1999) This European Standard was approved by CEN on 9 September 2000. CEN members are bound to comply with the CEWCENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national st

11、andard 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, French, German). A version in any other

12、 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, Czech Republic, Denmark, Finland, France, Germany, Gre

13、ece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMEE FOR STANDARDIZATION EUROPISCHES KOMITEE FR NORMUNG COMITE EUROPEEN DE NORMALISATION Central Secretariat: rue de Stassart, 36 B-1050 Brussels O 2000 CEN All rights o

14、f exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN IS0 10637:2000 E STD-BSI BS EN IS0 10b37-ENGL 2000 E lb2Libb9 0882262 200 1111 EN IS0 10637:2000 Foreword The text of the International Standard from Technical Committee ISOTTC 106 “Dentistry“ of the

15、 International Organization for Standardization (ISO) has been taken over as an European Standard by 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

16、 or by endorsement, at the latest by April 2001, and conflicting national standards shall be withdrawn at the latest by April 2001. According to the CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria

17、, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard IS0 10637:1999 has been approved by CEN as a European

18、 Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). STD.BSI BS EN IS0 IOb37-ENGL 2000 Lb24bb9 0882283 147 EN IS0 10637:2000 I NTE R NAT I O N AL STANDARD IS0 10637 First edition 1999-08-01 Dental equipment - High- and medium-

19、volume suction systems Matriel dentaire - Systmes daspiration haut et moyen volume Reference number IS0 10637: 1999(E) STD-BSI BS EN IS0 LOb37-ENGL 2000 II Lb24bb 088228Y 083 U EN IS0 10637:2000 Contents Page 1 Scope 1 2 Normative references 1 3 Terms and definitions . 2 4 Classification 4 5 Require

20、ments . 5 6 Sampling . 10 7 Test procedures . 10 8 Information to be supplied by the manufacturer 14 9 Marking . 15 10 Packaging . 16 Annex A (normative) Sequence of testing 17 II STD.BSI BS EN IS0 10637-ENGL 2000 H Lb24bb 0882285 T1T EN IS0 10637:ZOOO Foreword IS0 (the International Organization fo

21、r 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 cornmittee has been established has th

22、e 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. Internat

23、ional Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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 membe

24、r bodies casting a vote. International Standard IS0 10637 was prepared by Technical Committee ISOTTC 106, Denfistry, Subcommittee SC 6, Dental equipment. Annex A forms a normative part of this International Standard. . 111 STD-BSI BS EN IS0 LOb37-ENGL 2000 II Lb24669 O88228b 95b = EN IS0 10637:2000

25、Introduction This International Standard contains specifications for high- and medium-volume suction systems which are used in the dental surgery as pari of the dental equipment. The aim of this International Standard is to ensure the reliable function of suction systems and the necessary safety in

26、common usage and within normal ambient conditions. Any item of dental equipment recommended by the manufacturer for use in connection with suction systems should not render the equipment unsafe. iv STD-BSI BS EN IS0 LOb37-ENGL 2000 Lb24bb9 0882287 892 9 EN IS0 10637:2000 Dental equipment - High- and

27、 medium-volume suction systems 1 Scope This International Standard applies to high- and medium-volume suction systems which are items of dental equipment. They are usually an integral part of a dental unit. This International Standard specifies performance and safety requirements as well as test pro

28、cedures for high- and medium-volume suction systems. It also contains specifications on manufacturers instructions, marking and packaging . This International Standard takes priority, where applicable, over IEC 60601 -1, as specified in the individual clauses of this International Standard. This Int

29、ernational Standard is not applicable to low-volume suction systems. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions o

30、f, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative do

31、cument referred to applies. Members of IS0 and IEC maintain registers of currently valid International Standards. IS0 1942-4, Dental vocabulary - Part 4: Dental equipment. IS0 7494, Dental units. IS0 9687, Dental equipment - Graphical symbols. IEC 60335-1 , Safety of household and similar electrical

32、 appliances - Part 1: General requirements. IEC 60601 -1 :1988, Medical electrical equipment - Part 1: General requirements for safety. IEC 60651, Sound level metres. 1 STD.BSI BS EN IS0 10b37-ENGL 2000 m lb24667 0882288 729 EN IS0 10637:ZOOO 3 Terms and definitions For the purposes of this Internat

33、ional Standard, the terms and definitions given in IEC 60601-1:1988, clause 2, and the following apply. 3.1 suction system active entity of dental equipment, including a suction machine, which enables an air flow to be induced which is designed to remove spray, liquids and solids from the mouth of t

34、he dental patient during dental treatment See Figure 1. NOTE It is a combination of apparatus and accessories. Some components are described in 3.2 to 3.7. 3.2 suction device passive entity which can only induce an air flow when connected to a suction machine 3.3 air separator apparatus which separa

35、tes liquids and solids from the suction air 3.4 filter apparatus which retains solids from the air and liquids passing through it 3.5 central system vacuum system having at least one suction machine which serves more than one device 3.6 accessories cannula, manifold, filter and/or mobile support 3.7

36、 cannula connector cartridge, at the end of the hose part of the suction system, intended for fitting of cannulae and for placement in the mobile support NOTE Also called a suction handpiece. 3.8 low-volume suction system suction system with an air intake of less than 90 Vmin 2 STD.BS1 BS EN IS0 LOb

37、37-ENGL 2000 M I1624669 0882289 bb5 EN IS0 10637:2000 t7 U Symbol Ref. No. nT7 U U Suction handpiece Staple IS0 7000-1831 IS0 7000-0703 Filter IS0 1219-1 Drains trap IS0 7000-0157 Rotary compressor, iquid-ring type IS0 7000-0138 Compressor; vacuum pump IS0 7000-0137 Air outlet IS0 1219-1 Draining; e

38、mptying IS0 1000-0029 Graphical symbol c3 LI U Flow chart of suction systems Dry system Semi-dry system Wet system Level of separation of liquids and solids: t/=l Fj 0 . ., 1 I. High Medium Low Figure 1 - Suction systems 3 STD.BSI BS EN IS0 LOb37-ENGL 2000 lb24bb9 0885290 387 EN IS0 10637:2000 4 Cla

39、ssification 4.1 According to the air volume flowrate provided Suction systems to which this International Standard is applicable are classified according to the air volume flowrate provided as follows: a) High-volume suction system Suction system with an air intake of more than 250 litres per minute

40、 (Vmin) in each suction device. b) Medium-volume suction system Suction system with an air intake between 90 I/min and 250 hin in each suction device. 4.2 According to the type of suction Suction systems are classified according to the type of suction as follows: Dry system Suction system in which,

41、with an air separator, liquids and solids have been removed from the air flow before the air enters the suction machine and in which the separator and the suction machine are two different devices. See Figure 1. Semi-dry system Suction system in which, with an air separator, liquids and solids have

42、been removed from the air flow before the air enters the suction machine and in which the separator and the suction machine are combined into one device. See Figure 1. Wet system Suction system in which solids have been removed from the air flow by a filter before air and liquid enter the suction ma

43、chine, where they in turn are separated. See Figure 1. 4.3 According to the type of protection against electric shock (see IEC 60601-1) Suction systems are classified according to the type of protection against electric shock by classes as follows: a) Class I equipment Equipment in which protection

44、against electric shock does not rely on basic insulation only, but includes an additional safety precaution which provides means for the connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation such that accessible conductive parts cannot

45、become live in the event of a failure of the basic insulation. b) Class II equipment Equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no

46、 provision for protective earthing or reliance upon installation conditions. 4 STD.BSI BS EN IS0 LOb37-ENGL 2000 M Lb24bb9 08822q1 233 = EN IS0 10637:2000 4.4 According to the degree of protection against electric shock (see IEC 60601-1) Suction systems are classified according to the degree of prot

47、ection against electric shock by type as follows: a) Type B equipment (see IEC 60601 -1 :1988, 2.2.24) Class I or II equipment or equipment with an internal electrical power source providing an adequate degree of protection against electric shock, particularly regarding: - allowable leakage current;

48、 - reliability of the protective earth connection, if present. NOTE excluding direct cardiac application. Type 8 equipment is, for example, suitable for intentional external and internal application to the patient, b) Type BF equipment (see IEC 60601 -1 :1988,2.2.25) Type B equipment with an F-type

49、isolated (floated) applied part. 4.5 According to the mode of operation (see IEC 60601-1:1988, 2.10) Suction systems are classified as applicable for either intermittent or continuous operation. 5 Requirements 5.1 General This clause contains requirements relevant to high- and medium-volume suction systems. Many of these requirements are quantitatively verifiable as detailed in clause 7. Some requirements are objectively verifiable by visual inspection. Compliance with some requirements, however, involves a subjective decision of qualified testing person