BS-EN-ISO-10637-2000.pdf

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 10637:2000 The European Standard EN ISO 10637:2000 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental equipment Ð High- and medium- volume suction systems Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the 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 BSI 12-2000 ISBN 0 580 36596 4 BS EN ISO 10637:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 10637:2000. It is identical with ISO 10637:1999. The UK participation in its preparation was entrusted to Technical Committee CH/60, Dental equipment, which has the responsibility to: Ð aid enquirers to understand the text; Ð present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; Ð monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can 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 international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled ªInternational Standards Correspondence Indexº, or by using the ªFindº facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include 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, the EN ISO title page, the EN ISO foreword page, the ISO 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. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 10637 October 2000 ICS 11.060.20 English version Dental equipment - High- and medium-volume suction systems (ISO 10637:1999) Matériel dentaire - Systèmes d'aspiration à haut et moyen volume (ISO 10637:1999) Zahnärztliche Ausrüstungen - Absaugsysteme mit hoher und mittlerer Durchflußmenge (ISO 10637:1999) This European Standard was approved by CEN on 9 September 2000. 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 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 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, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels © 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10637:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 egaP OSI NE 0002:73601 Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the 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 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 CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, 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 ISO 10637:1999 has been approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI A Reference number ISO 10637:1999(E) INTERNATIONAL STANDARD ISO 10637 First edition 1999-08-01 Dental equipment High- and medium- volume suction systems Matériel dentaire Systèmes d'aspiration à haut et moyen volume EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(9991:73601 OSI ii Contents Page 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Classification4 5 Requirements.5 6 Sampling.10 7 Test procedures.10 8 Information to be supplied by the manufacturer14 9 Marking.15 10 Packaging.16 Annex A (normative) Sequence of testing17 EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI © OSI)E(9991:73601 OSI iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International 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 member bodies casting a vote. International Standard ISO 10637 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. Annex A forms a normative part of this International Standard. EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(9991:73601 OSI © OSI iv Introduction This International Standard contains specifications for high- and medium-volume suction systems which are used in the dental surgery as part of the dental equipment. The aim of this International Standard is to ensure the reliable function of suction systems and the necessary safety in 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. EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI LANOITANRETNI DRADNATS © OSI)E(9991:73601 OSI 1 Dental equipment High- and 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 procedures for high- and medium-volume suction systems. It also contains specifications on manufacturer's 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 International 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 of, 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 document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1942-4, Dental vocabulary Part 4: Dental equipment. ISO 7494, Dental units. lSO 9687, Dental equipment Graphical symbols. IEC 60335-1, Safety of household and similar electrical appliances Part 1: General requirements. IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety. IEC 60651, Sound level metres. EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(9991:73601 OSI © OSI 2 3 Terms and definitions For the purposes of this lnternational Standard, the terms and definitions given in lEC 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 the 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 separates 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 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 l/min EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI © OSI)E(9991:73601 OSI 3 Figure 1 Suction systems EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(9991:73601 OSI © OSI 4 4 Classification 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 (l/min) in each suction device. b) Medium-volume suction system Suction system with an air intake between 90 l/min and 250 l/min in each suction device. 4.2 According to the type of suction Suction systems are classified according to the type of suction as follows: a) Dry system Suction system in which, 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. b) Semi-dry system Suction system in which, 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 combined into one device. See Figure 1. c) Wet system Suction system in which solids have been removed from the air flow by a filter before air and liquid enter the suction machine, 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 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 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 provision for protective earthing or reliance upon installation conditions. EN ISO 10637:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:00:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI © OSI)E(9991:73601 OSI 5 4.4 According to the degree of protection against electric shock (see IEC 60601-1) Suction systems are classified according to the degree of protection 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; reliability of the protective earth connection, if present. NOTE Type B equipment is, for example, suitable for intentional external and internal application to the patient, excluding direct cardiac application. b) Type BF eq