BS EN ISO 8185-2009 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems《医用呼吸道加湿器 呼吸加湿系统详细要求》.pdf

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1、BS EN ISO 8185:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDRespiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems (ISO 8185:2007)This British Standard was published under the authority of

2、 the Standards Policy and Strategy Committee on 31 July2009 BSI 2009ISBN 978 0 580 65563 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 8185:2009National forewordThis British Standard is the UK implementation of EN ISO 8185:2009. It is identical to ISO 8185:2007. It supersedes

3、 BS EN ISO 8185:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication doe

4、s not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 8185April 2009ICS 11.040.10 Supersedes EN IS

5、O 8185:2007 English VersionRespiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO8185:2007)Humidificateurs respiratoires mdicaux - Exigences spcifiques des systmes dhumidification respiratoires (ISO 8185:2007)Anfeuchter fr Respirationsluft

6、 fr medizinische Zwecke -Besondere Anforderungen an Anfeuchtersysteme fr Respirationsluft (ISO 8185:2007)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand

7、ard 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 CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French,

8、 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 CEN Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Cze

9、ch Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EURO

10、PEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, 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 ISO 8185:2009: EBS EN ISO 8185:2009EN ISO 8185:2009 (E) 3 Foreword The text

11、 of ISO 8185:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8185:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretar

12、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 October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to

13、the possibility 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 ISO 8185:2007. This document has been prepared under a mandate given to CEN by t

14、he European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards org

15、anizations 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

16、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8185:2007 has been approved by CEN as a EN ISO 8185:2009 without any modification. BS EN ISO 8185:2009EN ISO 8185:2009 (E) 4 Annex ZA (Informative) Relationship between this European St

17、andard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC

18、on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the sc

19、ope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 9

20、3/42/EEC Qualifying remarks/Notes All 1 (first paragraph), 2, 3 4 3.6 cc) 12.1 6 13.1, 13.2, 13.3 And via IEC 60601-1, Clause 6 6.1 aa) 13.1 6.1 d) 13.1, 13.2, 13.3 b) 6.1 e) 13.1, 13.3 a) 6.1 f) 13.1, 13.3 b) 6.3 10.1, 10.3, 12.9 And via IEC 60601-1, Subclause 6.3 6.4, 6.5 13.2 6.6 9.1 And via IEC

21、60601-1, Subclause 6.6 6.7 12.9 And via IEC 60601-1, Subclause 6.7 6.8.2 13.1 6.8.2 a) 2, 13.3 k), 13.3 m), 13.4, 13.5, 13.6 a),13.6 b), 13.6 c), 13.6 d), 13.6 i), 13.6 j),13.6 o) 6.8.2 d) 13.6 h) 10.1 5 And via IEC 60601-1, Subclause 10.1 BS EN ISO 8185:2009EN ISO 8185:2009 (E) 5 Clause(s)/sub-clau

22、se(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 10.2 4 10.2.101 12.7.4 15 12.6 Via IEC 60601-1, Clause 15 16 12.6 Via IEC 60601-1, Clause 16 17 12.6 Via IEC 60601-1, Clause 17 18 12.6 Via IEC 60601-1, Clause 18 19 12.6 Via IEC 6060

23、1-1, Clause 19 20 12.6 Via IEC 60601-1, Clause 20 21 4, 5, 9.2, 12.7.1 And via IEC 60601-1, Clause 21 22 12.7.1 Via 60601-1, Clause 22 23 4, 9.2, 12.7.1 Via IEC 60601-1, Clause 23 24 4, 12.7.1 And via IEC 60601-1, Clause 24 25 12.7.1 Via IEC 60601-1, Clause 25 26 12.7.2 Via IEC 60601-1, Clause 26 28

24、 12.7.1 Via IEC 60601-1, Clause 28 29 11.3.1 Via IEC 60601-1, Clause 29 35 12.7.3 And via IEC 60601-1, Clause 35 35.101 4, 12.7.3 36 4, 9.2, 12.5 And via IEC 60601-1, Clause 36 36.202.1 9.2 37, 38, 39, 40, 41 9.3 42 12.7.5 42.101 4, 12.7.5, 12.8.1 43 7.1, 9.3 And via IEC 60601-1, Clause 43 43.101 7.

25、1, 7.3 44 7.2, 7.5, 7.6 44.2 7.2, 7.5 44.3 7.6 44.4 7.5 44.6 7.6 44.7 8.1, 8.4, 8.5 Via IEC 60601-1, Subclause 44.7 BS EN ISO 8185:2009EN ISO 8185:2009 (E) 6 Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 44.8 7.

26、1, 7.2, 7.3 45 9.2 Via IEC 60601-1, Clause 45 46 10.2 Via IEC 60601-1, Clause 46 48 7.1 Via IEC 60601-1, Clause 48 49 4, 9.2 And via IEC 60601-1, Clause 49 50 10.1, 12.8.1 50.1 12.9 50.2 10.1, 10.2 50.2 aa) 2, 12.8.1 50.2 bb) 2, 12.8.1 50.2 cc) 2, 12.8.2 51 12.8.1 Via IEC 60601-1, Clause 51 51 4 51.

27、101, 51.102, 51.103 2, 12.8.1 52 7.2, 7.6, 9.2, 9.3, 12.7.1 Via IEC 60601-1, Clause 52 56 9.1, 12.6, 12.7.5 And via IEC 60601-1, Clause 56 56.3 9.1, 12.7.5 56.7 9.3 Via IEC 60601-1, Subclause 56.7 56.101 7.2, 7.3, 9.1, 12.8.1, 12.8.2, 13.5 56.102 7.5, 9.1, 13.5 57 12.6, 12.7.4 Via IEC 60601-1, Claus

28、e 57 58 12.6 Via IEC 60601-1, Clause 58 59 9.3, 12.6 Via IEC 60601-1, Clause 59 101 3, 4 102 3, 10.2 103 2, 9.1, 12.7.3, 12.9, 13.1, 13.2, 13.6 d) Via IEC 60601-1, Clause 6 and via IEC60601-8 201 2 Via IEC 60601-8 - 1 (first paragraph and 2ndparagraph, 1stdash) This relevant Essential Requirement is

29、 not addressed in this European Standard - 1 (first paragraph and 2ndparagraph, 2nddash) This relevant Essential Requirement is not addressed in this European Standard - 6a This relevant Essential Requirement is not addressed in this European Standard BS EN ISO 8185:2009EN ISO 8185:2009 (E) 7 48 7.5

30、 (1stparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 7.5 (2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 7.5 (3rdparagraph) This relevant Essential Requirement is not fully addressed in this

31、 European Standard - 12.1a) This relevant Essential Requirement is not addressed in this European Standard. 6.1 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 6.1 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Stan

32、dard 6.8.2 13.6 (h)(2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 13.6 (h)(3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 13.6 (q) This relevant Essential Requirement is not addresse

33、d in this European Standard WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8185:2009EN ISO 8185:2009 (E) 8 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on

34、Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this Europe

35、an Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this Europe

36、an Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN Essential Health and Safety Requirements (EHSRs) of 2006/42/EC Qualifying remarks/Notes- 1.1.4 Lighting This relevant EHSR is not addressed in this European Standard 50, 51 1.2.2 Control devices Th

37、is relevant EHSR is not fully addressed in this European Standard 6, 56 1.5.4 Errors of fitting This relevant EHSR is not fully addressed in this European Standard - 1.6.1 Machinery maintenance This relevant EHSR is not addressed in this European Standard - 1.6.2 Access to operating positions and se

38、rvicing points This relevant EHSR is not addressed in this European Standard - 1.6.3 Isolation of energy sources This relevant EHSR is not addressed in this European Standard - 3.6.2 Marking This relevant EHSR is not addressed in this European Standard BS EN ISO 8185:2009ISO 8185:2007(E) ISO 2007 Al

39、l rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 General requirements and general requirements for tests 4 5 Classification. 4 6 Identification, marking and documents 5 7 Power input . 7 8 Basic safety categories 7 9

40、 Removable protective means 7 10 Environmental conditions 7 11 Not used. 8 12 Not used. 8 13 General. 8 14 Requirements related to classification. 8 15 Limitation of voltage and/or energy 8 16 Enclosures and protective covers 8 17 Separation . 8 18 Protective earthing, functional earthing and potent

41、ial equalization . 8 19 Continuous leakage currents and patient auxiliary currents. 8 20 Dielectric strength 9 21 Mechanical strength . 9 22 Moving parts 9 23 Surface, corners and edges. 9 24 Stability in normal use 9 25 Expelled parts . 9 26 Vibration and noise. 9 27 Pneumatic and hydraulic power 9

42、 28 Suspended masses 9 29 X-Radiation 10 30 Alpha, beta, gamma, neutron radiation and other particle radiation 10 31 Microwave radiation . 10 32 Light radiation (including lasers) 10 33 Infra-red radiation . 10 34 Ultraviolet energy 10 35 Acoustical energy (including ultrasonics) . 10 BS EN ISO 8185

43、:2009ISO 8185:2007(E) iv ISO 2007 All rights reserved36 Electromagnetic compatibility. 11 37 Locations and basic requirements 11 38 Marking, accompanying documents. 11 39 Common requirements for category AP and category APG equipment . 11 40 Requirements and tests for category AP equipment, parts an

44、d components thereof 11 41 Requirements and tests for category APG equipment, parts and components thereof . 11 42 Excessive temperatures . 11 43 * Fire prevention 12 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 12 45 Pressure vessels and par

45、ts subject to pressure . 13 46 Human error. 13 47 Electrostatic charges 13 48 Biocompatibility 13 49 Interruption of power supply . 13 50 Accuracy of operating data 14 51 * Protection against hazardous output . 14 52 Abnormal operation and fault conditions. 15 53 Environmental tests 16 54 General .

46、16 55 Enclosure and covers. 16 56 Components and general assembly . 16 57 Mains parts, components and layout 17 58 Protective earthing Terminals and connections . 17 59 Construction and layout. 18 101 * Humidification system output . 18 102 Liquid container 18 103 Alarm systems. 18 Annex AA (informa

47、tive) Rationale. 20 Annex BB (normative) * Determination of the accuracy of the displayed temperature 27 Annex CC (informative) Specific enthalpy calculations . 29 Annex DD (normative) Temperature sensors and mating ports 35 Annex EE (normative) * Determination of humidification system output 36 Ann

48、ex FF (normative) * Standard temperature sensor. 39 Annex GG (informative) Environmental aspects. 41 Annex HH (informative) Reference to the essential principals of safety and performance 44 Annex II (informative) Terminology Index of defined terms 46 Bibliography . 48 BS EN ISO 8185:2009ISO 8185:20

49、07(E) ISO 2007 All rights reserved vForeword 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 co