BS-EN-ISO-8185-1998 BS-5724-2.24-1998.pdf
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1、BRITISH STANDARD BS EN ISO 8185:1998 BS 5724-2-24: 1998 Incorporating Corrigendum No. 1 Humidifiers for medical use General requirements for humidification systems The European Standard EN ISO 8185:1997 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na,
2、Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8185:1998 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 1998 BSI 19 Februa
3、ry 2003 ISBN 0 580 29252 5 National foreword This British Standard is the English language version of EN ISO 8185:1997, including Corrigendum July 2002. It is identical with ISO 8185:1997, including Corrigendum May 2001. It supersedes BS 5724-2-24:1989 which will be withdrawn on 13 June 1998. The UK
4、 participation in its preparation was entrusted by Technical Committee CH/46, Lung Ventilators and related equipment, to Subcommittee CH/46/1, Heat and moisture exchangers and humidifiers, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on re
5、quest to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI
6、 Electornic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obli
7、gations. aid enquirers to understand the text; present to the responsible international/European 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. Summary
8、of pages This document comprises a front cover, an inside front cover, page i, a blank page, the EN ISO title page, page 2, the ISO title page, pages ii to v, a blank page, pages 1 to 42, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the do
9、cument was last issued. Amendments issued since publication Amd. No.DateComments 14088 Corrigendum No. 1 19 February 2003 Correction to 56.3 of Section 10 and replacement of the formula for vapour pressure in Annex O Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Unc
10、ontrolled Copy, (c) BSI BS EN ISO 8185:1998 BSI 19 February 2003 i Contents Page National forewordInside front cover EN foreword 2 ISO forewordv Text of ISO 81851 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffield
11、un sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8185 November 1997 ICS 11.040.10Incorporating Corrigendum July 2002 Descriptors: See ISO document English version Humidifiers for medical use General requiremen
12、ts for humidification systems (ISO 8185:1997) Humidificateurs mdicaux Exigences gnrales relatives aux systmes dhumidification (ISO 8185:1997) This European Standard was approved by CEN on 26 September 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
13、 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
14、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
15、 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Ce
16、ntral Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8185:1997 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
17、EN ISO 8185:1997 BSI 19 February 2003 2 Foreword The text of the International Standard ISO 8185:1997 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the Secretar
18、iat of which is held by BSI. 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 May 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard has
19、been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CEN/CEN
20、ELEC 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, Sw
21、itzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 8185:1997 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZB (normative). Licensed Copy: sheffieldun sheffieldu
22、n, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Incorporating Corrigendum 2001-05-15 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8185:1997 ii Contents Page Forewordv Section 1. General Introduction1 1.1Scope1
23、 1.2Normative references2 1.3Definitions2 1.4General requirements4 1.5General requirements for tests4 1.6Classifications4 1.7Identifications, marking and documents4 1.8Power input6 Section 2. Environmental conditions 2.1Basic safety requirements7 2.2Removable protective means7 2.3Environmental condi
24、tions7 Section 3. Protections against electric shock hazards 3.1General9 3.2Requirements related to classification9 3.3Limitation of voltage and/or energy9 3.4Enclosures and protective covers9 3.5Separation9 3.6Protective earthing, functional earthing and potential equalization9 3.7Continuous leakag
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