EN ISO 17510-1-2009 en Sleep apnoea breathing therapy - Part 1 Sleep apnoea breathing therapy equipment《睡眠窒息呼吸治疗 第1部分 睡眠窒息呼吸治疗设备》.pdf

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1、BS EN ISO17510-1:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSleep apnoeabreathing therapyPart 1: Sleep apnoea breathing therapyequipment (ISO 17510-1:2007)This British Standardwas published under theauthority of the StandardsPolicy and Stra

2、tegyCommittee on 30 April2009 BSI 2009ISBN 978 0 580 65196 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 17510-1:2009National forewordThis British Standard is the UK implementation of EN ISO17510-1:2009. It is identical to ISO 17510-1:200 . It supersedes BS ENISO 17510-1:2007

3、 and which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to in

4、clude all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.7EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 17510-1March 2009ICS 11.040.10 Supersedes EN ISO 17510-1:2007 Engl

5、ish VersionSleep apnoea breathing therapy - Part 1: Sleep apnoeabreathing therapy equipment (ISO 17510-1:2007)Thrapie respiratoire de lapne du sommeil - Partie 1:quipement de thrapie respiratoire de lapne du sommeil(ISO 17510-1:2007)Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-Atemtherapiegerte (I

6、SO 17510-1:2007)This European Standard was approved by CEN on 24 February 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibl

7、iographical references concerning such nationalstandards 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, German). A version in any other language made by translationunder the responsibility of

8、 a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland,

9、 Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000

10、 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 17510-1:2009: EBS EN ISO 17510-1:2009EN ISO 17510-1:2009 (E) 3 Foreword The text of ISO 17510-1:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic

11、and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 17510-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of

12、 a national standard, either by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject

13、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 17510-1:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and support

14、s 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 organizations of the following countries are bound to implement this European

15、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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United King

16、dom. Endorsement notice The text of ISO 17510-1:2007 has been approved by CEN as a EN ISO 17510-1:2009 without any modification. BS EN ISO 17510-1:2009EN ISO 17510-1:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC

17、 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 on medical devices. Once this standard is cited in the Official

18、 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 scope of this standard, a presumption of conformity with the corr

19、esponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying rema

20、rks/Notes All 1, 2, 3 4 6, 12.6- 6a This relevant Essential Requirement is not addressed in this European Standard 6 13 6 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in th

21、is European Standard 6.1 2, 13.3 a) 6.1 aa) to cc) 13.6 c), d) 6.1 dd) 8.7, 9.1, 13.3, 13.4, 13.5 6.1 dd) 7th dash 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 e) 13.3 (a): This relevant Essential Requirement is not fully addressed in this Europea

22、n Standard 6.3 10.2, 10.3, 12.9BS EN ISO 17510-1:2009EN ISO 17510-1:2009 (E) 5 6.8.2 13.6 b), c), h), i), l) 6.8.3 13.6 c), d), p), n) 10.1 8.3 10.101, 10.102 4 13, 15, 17, 18,19, 20 12.6 21 5, 9.2, 12.7.1 23 4, 9.224 12.7.126 12.7.2, 12.7.3 36 4, 9.2, 11.3.1, 12.5 38 13.2, 13.439, 40, 41 9.3 42 9.2

23、, 12.7.543 7.1, 7.2, 9.3 43.101 7.1, 9.344 4, 7.2, 7.3, 7.5, 7.6, 8.1, 8.6 44.6 7.6 44.7 8.3, 8.5 46 9.2, 10.2, 12.8.2, 12.9 48 7.2, 7.5 49 4 49.101 12.8.1, 12.8.2 51 12.8.1, 12.8.251.5 2, 12.8.2, 12.9 51.101 12.8.251.102 10.1, 10.2, 12.8.2 51.103 10.1, 10.2, 12.8.251.104 4, 12.8.1, 12.8.2 51.105 4,

24、 12.8.252 12.1 BS EN ISO 17510-1:2009EN ISO 17510-1:2009 (E) 6 54 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 54 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (3rd paragraph)

25、 This relevant Essential Requirement is not fully addressed in this European Standard - 12.1a) This relevant Essential Requirement is not addressed in this European Standard. 54.1 12.1, 12.9 54.101 7.556.3 9.1, 12.7.4 56.10 12.956.101.1 7.3, 8.1, 8.4 56.101.2 7.3, 8.1, 8.6 56.102 9.1 BS EN ISO 17510

26、-1:2009EN ISO 17510-1:2009 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on 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

27、 to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European 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 mach

28、inery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN EHSR o 2006/42/EC Qualifying remarks/Notes- 1.1.4 This relevant E

29、HSR is not addressed in this European Standard 6.8.2, 56 1.5.4 This relevant EHSR is not fully addressed in this European Standard - 1.6.1 This relevant EHSR is not addressed in this European Standard - 1.6.2 This relevant EHSR is not addressed in this European Standard - 1.6.3 This relevant EHSR is

30、 not addressed in this European Standard - 3.6.2 This relevant EHSR is not addressed in this European Standard Warning Other requirements and other EU Directives may be applicable to the products falling within the scope of this International standard. BS EN ISO 17510-1:2009ISO 17510-1:2007(E) ISO 2

31、007 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 * Scope 1 2 Normative references . 1 3 Terms and definitions. 3 4 Requirements 4 5 Classification and designation 4 6 Marking, labelling and packaging . 4 7 Power input . 8 8 Basic safety categories 8 9 Removable protective mea

32、ns 8 10 Environmental conditions 8 11 Not used. 9 12 Not used. 9 13 General. 9 14 Requirements related to classification. 9 15 Limitation of voltage and/or energy 9 16 Enclosures and protective covers 9 17 Separation . 9 18 Protective earthing, functional earthing and potential equalization . 9 19 C

33、ontinuous leakage currents and patient auxiliary currents. 9 20 Dielectric strength 10 21 Mechanical strength . 10 22 Moving parts 10 23 Surfaces, corners and edges. 10 24 Stability in normal use 10 25 Expelled parts . 10 26 * Vibration and noise . 10 27 Pneumatic and hydraulic power 11 28 Suspended

34、 masses 11 29 X-radiation . 11 30 Alpha, beta, gamma, neutron radiation and other particle radiation 11 31 Microwave radiation . 11 32 Light radiation (including lasers) 12 33 Infra-red radiation . 12 BS EN ISO 17510-1:2009ISO 17510-1:2007(E) iv ISO 2007 All rights reserved34 Ultra-violet radiation

35、. 12 35 Acoustical energy (including ultra-sonics) 12 36 Electromagnetic compatibility. 12 37 Locations and basic requirements 12 38 Marking, accompanying documents. 12 39 Common requirements for Category AP and Category APG equipment 12 40 Requirements and tests for category AP equipment, parts and

36、 components thereof 12 41 Requirements and tests for category APG equipment, parts and components thereof . 13 42 Excessive temperatures . 13 43 Fire prevention 13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 13 45 Pressure vessels and parts

37、subject to pressure . 14 46 Human errors. 14 47 Electrostatic charges 14 48 Biocompatibility 15 49 Interruption of the power supply. 15 50 Accuracy of operating data 15 51 Protection against hazardous output . 15 52 Abnormal operation and fault conditions. 16 53 Environmental tests 16 54 General . 1

38、6 55 Enclosures and covers. 17 56 Components and general assembly . 17 57 Mains parts, components and layout 19 58 Protective earthing Terminals and connections . 19 59 Construction and layout. 19 Annex AA (informative) Rationale. 20 Annex BB (normative) * Pressure accuracy in normal use test method

39、s . 25 Annex CC (normative) Maximum flowrate test method 27 Annex DD (informative) Environmental aspects . 28 Annex EE (informative) Reference to the essential principles 30 Annex FF (informative) Terminology Alphabetized index of defined terms 32 Bibliography . 34 BS EN ISO 17510-1:2009ISO 17510-1:

40、2007(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

41、 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 Electrotec

42、hnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by

43、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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent righ

44、ts. ISO shall not be held responsible for identifying any or all such patent rights. ISO 17510-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This second edition cancels and replaces the first editio

45、n (ISO 17510-1:2002) which has been technically revised. ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy: Part 1: Sleep apnoea breathing therapy equipment Part 2: Masks and application accessories BS EN ISO 17510-1:2009ISO 17510-1:2007(E) vi ISO 2007

46、 All rights reservedIntroduction Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equi

47、pment has become common. This document covers basic safety and essential performance requirements needed to protect patients in the use of this equipment. This document is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the Genera

48、l Standard. The General Standard is the basic document for the safety of medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. It also contains certain requirements for reliable operation to ensure safety. The General Sta

49、ndard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:198