BS EN ISO 18778-2009 Respiratory equipment - Infant monitors - Particular requirements(ISO 18778 2005)《呼吸设备 婴儿监视器 详细要求(ISO 18778-2005)》.pdf

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1、BS EN ISO 18778:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDRespiratory equipment Infant monitors Particular requirements (ISO 18778:2005)This British Standard was published under the authority of the Standards Policy and Strategy Committee

2、on 31 July 2009. BSI 2009ISBN 978 0 580 65561 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 18778:2009National forewordThis British Standard is the UK implementation of EN ISO 18778:2009. It is identical to ISO 18778:2005. It supersedes BS EN ISO 18778:2005 which is withdrawn

3、.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 does not purport to include all the necess

4、ary 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 18778April 2009ICS 11.040.10 Supersedes EN ISO 18778:2005 English VersionRespirator

5、y equipment - Infant monitors - Particular requirements (ISO 18778:2005)Matriel respiratoire - Moniteurs pour enfants - Exigences particulires (ISO 18778:2005)Beatmungsgerte - berwachungsgerte fr Kleinkinder -Besondere Anforderungen (ISO 18778:2005)This European Standard was approved by CEN on 21 Ma

6、rch 2009.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 obta

7、ined 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Managem

8、ent Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

9、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and

10、by any means reserved worldwide for CEN national Members.Ref. No. EN ISO 18778:2009: E3 Foreword The text of ISO 18778:2005 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

11、as EN ISO 18778:2009 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 a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009

12、, 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 of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. T

13、his document supersedes EN ISO 18778:2005. This document has been prepared under a mandate given to CEN by the 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 i

14、ntegral 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 Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hun

15、gary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18778:2005 has been approved by CEN as a EN ISO 18778:2009 without any modifi

16、cation. BS EN ISO 18778:2009 ISO 18778:2005(E)4 Annex ZA (Informative) Relationship between this European Standard 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 Ass

17、ociation 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 Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member

18、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 corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this Intern

19、ational Standard and Directive 93/42/EEC Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 All 5 All 6 13, 13.2 6.1 7.5 (3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard

20、 - 12.1a) This relevant Essential Requirement is not addressed in this European Standard. 6.1 d) 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2aa) 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2

21、 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 this European Standard BS EN ISO 18778:2009 ISO 18778:2005(E)5 6.3 10.2, 10.3, 12.8, 12.9 6.8 13.1, 13.3, 13.4, 13.6 6.101

22、12.9 7 12.6 8 12.6 9 12.6 10.1 5 10.2 5 13 12.6 14 12.6 15 12.6 16 12.6, 12.7 17 12.6 18 12.6 19 12.6 20 12.6 21 12.7 22 12.7 23 12.7 24 12.7 25 12.7 26 12.7.2, 12.7.3 27 12.8 28 12.7 29 11 36 9.2, 12.5 38 13 39 9.2, 9.3, 12.6, 12.7 40 9.2, 9.3, 12.6, 12.7 41 9.2, 9.3, 12.6, 12.7 42 12.7 43 9.3, 12.

23、7 44.3 7.6, 12.6 44.6 7.6, 12.6 44.7 8.1 BS EN ISO 18778:2009 ISO 18778:2005(E)6 44.8 7.1, 7.3, 7.5, 9.3 45 12.7 46 9, 10, 12.9 47 12.5 - 6a) This relevant Essential Requirement is not addressed in this European Standard - 7.5 (1st paragraph) This relevant Essential Requirement is not fully addresse

24、d in this European Standard 48 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 48 7.1, 7.5 49 9.2, 12.8 50 10 51 10, 12.8 52 12.1, 12.6, 12.7, 12.8 53 5 54 9 55 9 56 9 56.3 9.1 56.7 12.2 57 12.6, 12.7 58 12.6, 12.7 101.2.1 9.2, 12.8 101.2.3 12

25、.8 101.2.4 12.8 101.2.6 12.8 101.2.7 12.2 101.2.8 9.3, 12.6, 12.8 101.3 12.3, 12.8 WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 18778:2009 ISO 18778:2005(E) ISO 2005 All rights reserved iiiContents Page F

26、oreword. v Introduction . vi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements and general requirements for tests 3 5 Classification. 3 6 Identification, marking and documents 3 7 Power input 7 8 Basic safety categories 7 9 Removable protective means 8 10 Environ

27、mental conditions 8 11 Not used. 8 12 Not used. 8 13 General. 8 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 Continuous leakag

28、e currents and patient auxiliary currents . 9 20 Dielectric strength. 9 21 Mechanical strength . 9 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 10 28 Suspended masses. 10 29 X-Radi

29、ation 11 30 Alpha, beta, gamma, neutron radiation and other particle radiation. 11 31 Microwave radiation 11 32 Light radiation (including lasers) 11 33 Infrared radiation. 11 BS EN ISO 18778:2009 ISO 18778:2005(E)iv ISO 2005 All rights reserved34 Ultraviolet energy 11 35 Acoustical energy (includin

30、g ultrasonics)11 36 Electromagnetic Compatibility.11 37 Locations and basic requirements11 38 Marking and accompanying documents.11 39 Common requirements for category AP and category APG equipment12 40 Requirements and tests for category AP equipment, parts and components thereof 12 41 Requirements

31、 and tests for category APG equipment, parts and components thereof .12 42 Excessive temperatures .12 43 Fire prevention.12 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility13 45 Pressure vessels and parts subject to pressure .13 46

32、 Human errors .13 47 Electrostatic charges 14 48 Biocompatibility.14 49 Interruption of the power supply .14 50 Accuracy of operating data 14 51 Protection against hazardous output14 52 Abnormal operation and fault conditions.14 53 Environmental tests 15 54 General .15 55 Enclosures and covers .15 5

33、6 Components and general assembly15 57 Mains parts, components and layout15 58 Protective earthing Terminals and connections .15 59 Construction and layout .15 101 Additional requirements .16 Annex AA (informative) Rationale .20 Annex BB (informative) Environmental aspects23 Annex CC (informative) I

34、ndex of defined terms.25 Bibliography26 BS EN ISO 18778:2009 ISO 18778:2005(E) ISO 2005 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

35、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

36、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 2. The main task of technical committees is to pre

37、pare International Standards. 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. Attention is drawn to the possibility that

38、some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18778 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment

39、, in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). BS EN ISO 18778:2009 ISO 18778:2005(E)vi ISO 2005

40、 All rights reservedIntroduction This International Standard specifies requirement for infant monitors (called in previous working documents “infant apnoea monitors” but with a too restrictive scope) which are used to recognize apparent life-threatening events in an infant who is asleep. These devic

41、es are for domiciliary use only. This International standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic standard for general medical and patient environment; it also

42、contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/for hazards and apply to all applicable equipment, such as medical sys

43、tems, 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 Definition of Collateral Standard and Particular can be found i

44、n IEC 60601-1:1988, 1.5 and A.2, respectively. To facilitate the use of this International Standard, the following drafting conventions have been applied. This International Standard uses the same main clause titles and numbering as the General Standard, for ease of cross-referencing of the requirem

45、ents. The changes to the text of the General Standard, as supplemented by the Collateral Standards, are specified by the use of the following words. “Replacement” means that the indicated clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “Add

46、ition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list item, note, table, figure) additional to the General Standard. “Amendment” means that an existing element of the General Standard is partially modified by deletion and/or addition as indicated by t

47、he text of this Particular Standard. To avoid confusion with any amendments to the General Standard itself, a particular numbering has been employed for elements added by this International Standard: clauses, subclauses, tables and figures are numbered starting from 101; additional list items are le

48、ttered aa), bb), etc. and additional Annexes are lettered AA, BB, etc. The term “this Standard” is used to make reference to the General Standard and this Standard taken together. Where there is no corresponding section, clause or subclause in this Standard, the section, clause or subclause of the G

49、eneral Standard, although possibly not relevant, applies without modification, where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Standard. Clauses and subclauses to which there is a rationale are marked with an throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an asterisk (*). This rationale can be found in the informative Annex AA. BS EN ISO 18778:2009 ISO 18778:2005(E)INTERNATIONAL