EN ISO 18779-2005 en Medical devices for conserving oxygen and oxygen mixtures - Particular requirements《储存氧和氧混合物的医疗设备 特殊要求 ISO 18779-2005》.pdf

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1、BRITISH STANDARD BS EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements The European Standard EN ISO 18779:2005 has the status of a British Standard ICS 11.040.10 BS EN ISO 18779:2005 This British Standard was published under the authority of the Stand

2、ards Policy and Strategy Committee on 24 March 2005 BSI 24 March 2005 ISBN 0 580 45685 4 National foreword This British Standard is the official English language version of EN ISO 18779:2005. It is identical with ISO 18779:2005. The UK participation in its preparation was entrusted by Technical Comm

3、ittee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/3, Lung ventilators and related equipment, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which i

4、mplement 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 Electronic Catalogue or of British Standards Online. This publication

5、 does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/Eur

6、opean 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 of pages This document comprises a front cover, an inside front cover, the EN ISO title pag

7、e, the EN ISO foreword page, the ISO title page, pages ii to vii, a blank page, pages 1 to 25, the Annex ZA pages, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date

8、 CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO18779 February2005 ICS11.040.10 Englishversion Medicaldevicesforconservingoxygenandoxygenmixtures Particularrequirements(ISO18779:2005) Economiseursmdicauxdoxygneetdemlanges oxygnsExigencesparticulires(ISO18779:2005) SpargertefrSauerstoffu

9、ndSauerstoffgemische BesondereAnforderungen(ISO18779:2005) ThisEuropeanStandardwasapprovedbyCENon28January2005. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbi

10、bliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnoti

11、fiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovaki

12、a, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2005CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO1

13、8779:2005:ENE ISO 781002:975 E() 2 Foreword This document (EN ISO 18779:2005) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipm

14、ent”. 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 August 2005, and conflicting national standards shall be withdrawn at the latest by August 2005. This document has been prepared under a manda

15、te 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 document. According to the CEN/CENELEC Internal Regulations,

16、the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po

17、land, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. ENISO18779:2005 Reference number ISO 18779:2005(E) OSI 5002INTERNATIONAL STANDARD ISO 18779 First edition 2005-02-15 Medical devices for conserving oxygen and oxygen mixtures Particular requirements conomiseurs mdicau

18、x doxygne et de mlanges oxygns Exigences particulires ENISO18779:2005IS:97781 O5002(E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt dedyfepcaes. In ccaocnadrw eith Aebods licensilop gnic,y this file mairp eb ynted iv roweb detu slahl ton ide ebtlnu deess the typefaces whice era hml era deddebicsn

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23、sr esedevrENISO18779:2005IS:97781 O5002(E) I SO 5002 All irthgs ersedevr iiiContents Page Foreword. 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 docume

24、nts 3 7 Power input 8 8 Basic safety categories 8 9 Removable protective means 8 10 Environmental conditions 9 11 Not used. 9 12 Not used. 9 13 General. 9 14 Requirements related to classification . 9 15 Limitation of voltage and/or energy 10 16 Enclosures and protective covers 10 17 Separation 10 1

25、8 Protective earthing, functional earthing and potential equalization . 10 19 Continuous leakage currents and patient auxiliary currents . 10 20 Dielectric strength. 10 21 Mechanical strength . 10 22 Moving parts 11 23 Surfaces, corners and edges. 11 24 Stability in normal use 11 25 Expelled parts 1

26、1 26 Vibration and noise. 11 27 Pneumatic and hydraulic power 11 28 Suspended masses. 11 29 X-Radiation 12 30 Alpha, beta, gamma, neutron radiation and other particle radiation. 12 31 Microwave radiation 12 32 Light radiation (including lasers) 12 33 Infrared radiation. 12 ENISO18779:2005IS:97781 O5

27、002(E) iv ISO 2005 All irthgs reserved34 Ultraviolet energy 12 35 Acoustical energy (including ultrasonics)12 36 Electromagnetic compatibility .12 37 Locations and basic requirements12 38 Marking and accompanying documents.12 39 Common requirements for category AP and category APG equipment12 40 Req

28、uirements and tests for category AP equipment, parts and components thereof.13 41 Requirements and tests for category APG equipment, parts and components thereof13 42 Excessive temperatures .13 43 Fire prevention.13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilizatio

29、n, disinfection and compatibility13 45 Pressure vessels and parts subject to pressure .14 46 Human errors .15 47 Electrostatic charges 15 48 Biocompatibility.15 49 Interruption of the power supply .15 50 Accuracy of operating data 15 51 Protection against hazardous output15 52 Abnormal operation and

30、 fault conditions.16 53 Environmental tests 16 54 General .16 55 Enclosures and covers .16 56 Components and general assembly16 57 Mains parts, components and layout16 58 Protective earthing Terminals and connections .17 59 Construction and layout .17 101 Additional requirements .17 Annex AA (inform

31、ative) Rationale .19 Annex BB (informative) Environmental aspects22 Annex CC (informative) Index of defined terms.24 Bibliography25 ENISO18779:2005IS:97781 O5002(E) I SO 5002 All irthgs ersedevr vForeword ISO (the International Organization for Standardization) is a worldwide federation of national

32、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

33、 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 g

34、iven in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare 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 leas

35、t 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 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18779 was prepared by the European Committee for Stan

36、dardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, 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 b

37、etween ISO and CEN (Vienna Agreement). ENISO18779:2005IS:97781 O5002(E) vi I SO 5002 All irthgs ersedevrIntroduction This International Standard specifies requirements for oxygen and oxygen mixture saving devices (called here conserving devices) that are used to supply respiratory gases during thera

38、py. These devices are for domiciliary use only. Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into the committees reasoning that led to a requirement and to identify the hazards that the requirement addresses. Clauses and subclauses marked w

39、ith an asterisk (*) after their number have a corresponding rationale contained in Annex AA. 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 st

40、andard for the safety of all 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 Standard has associated Collateral Standards an

41、d 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

42、 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 60601-1:1988, 1.5 and A.2, respectively. To facilitate the use of this International Standard, the follo

43、wing 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 requirements. The changes to the text of the General Standard, as supplemented by the Collateral Standards, are specif

44、ied 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 International Standard. “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list item

45、, 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 the text of this Particular Standard. To avoid confusion with any amendments to the General Standard itself,

46、 a particular numbering has been employed for elements added by this International Standard: subclauses, tables and figures are numbered starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB, etc. In this International Standard, the following

47、 print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; ENISO18779:2005IS:97781 O5002(E) I SO 5002 All irthgs ersedevr vii description of type of document change and test methods: italic type; terms defined in t

48、he General Standard IEC 60601-1:1988, Clause 2, or in this Particular Standard: bold type. Throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an asterisk (*). ENISO18779:2005blank 5002:97781OSINEINTENRATIONAL TSANDADR IS:97781 O5002(E)I SO 5002 All irthgs ersedevr 1Medical devices for conserving oxygen and oxygen mixtures Particular requirements 1 * Scope IEC 60601-1:1988, Clause 1, applies except as follows: Amendment (add at end of 1.1): 1.1