EN ISO 18777-2009 en Transportable liquid oxygen systems for medical use - Particular requirements《移动式医用液氧系统 特殊要求》.pdf

1、BS EN ISO 18777:2009 ICS 11.040.99 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Transportable liquid oxygen systems for medical use Particular requirements (ISO 18777:2005)This British Standard was published under the authority of the Standards Policy and S

2、trategy Committee on 31 July 2009. BSI 2009 ISBN 978 0 580 65202 8 Amendments/corrigenda issued since publication Date Comments BS EN ISO 18777:2009 National foreword This British Standard is the UK implementation of EN ISO 18777:2009. It is identical to ISO 18777:2005. It supersedes BS EN ISO 18777

3、:2005 which is withdrawn.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 does not purpor

4、t 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 NORM EN ISO 18777 March 2009 ICS 11.040.99 Supersedes EN ISO 18777

5、:2005 English Version Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) Systmes transportables doxygne liquide usage mdical - Exigences particulires (ISO 18777:2005) Flssigsauerstoffsysteme fr medizinische Anwendungen - Besondere Anforderungen (ISO 18777:

6、2005) 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographi

7、cal 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, German). A version in any other language made by translation under the responsibility of a CE

8、N 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, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, I

9、taly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1

10、000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18777:2009: EBS EN ISO 18777:2009 EN ISO 18777:2009 (E) 3 Foreword The text of ISO 18777:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic an

11、d respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 18777:2009 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 n

12、ational 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 of p

13、atent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 18777:2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports esse

14、ntial requirements of EC Directives. For relationship with EC Directives, 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 Stan

15、dard: 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 Kingdom.

16、 Endorsement notice The text of ISO 18777:2005 has been approved by CEN as a EN ISO 18777:2009 without any modification. BS EN ISO 18777:2009 EN ISO 18777:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This Europ

17、ean 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 Journal of

18、 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. confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Es

19、sential Requirements of that Directive and associated EFTA regulations. Table ZA. - 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 remarks/Notes 4

20、All 5 All - 6a This relevant Essential Requirement is not addressed in this European Standard 6 13, 13.2 6.1 13.1, 13.3, 13.4, 13.5 6.1, 6.8 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed

21、in this European Standard 6.3 10.2, 10.3, 12.8, 12.9 6.8 13.1, 13.3, 13.4, 13.6 6.8.2 aa) 2) 7.5 (3rd paragraph) 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. BS EN ISO 187

22、77:2009 EN ISO 18777:2009 (E) 5 6.101 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.

23、2, 9.3, 12.6, 12.7 42 12.7 43 9.3, 12.7 44.3 7.6, 12.6 44.6 7.6, 12.6 44.7 8.1 44.8 7.1, 7.3, 7.5, 9.3 BS EN ISO 18777:2009 EN ISO 18777:2009 (E) 6 45 12.7 46 9, 10, 12.9 47 12.5 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

24、 58 12.6, 12.7 101.2.1 9.2, 12.8 101.2.3 12.8 101.2.4 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 products falling within the scope of this International standard. BS EN ISO 18777:2009 ISO 18777:2

25、005(E) ISO 2005 All rights reserved 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 documents 3 7 Power input 8 8 Basic safety

26、categories 8 9 Removable protective means 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 10 18 Protective earthing, functional earth

27、ing and potential equalization . 10 19 Continuous leakage currents and patient auxiliary currents . 10 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 11 26 Vibration and noise. 11 27 Pneumat

28、ic and hydraulic power 11 28 Suspended 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) 11 33 Infrared radiation. 12 BS EN ISO 18777:2009 ISO 18777:2005(E) iv ISO 2005 All rights res

29、erved34 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 equipment 12 40 Requirements and tests for category

30、 AP equipment, parts and components thereof12 41 Requirements and tests for category APG equipment, parts and components thereof .12 42 Excessive temperatures .12 43 Fire prevention.13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibili

31、ty13 45 Pressure vessels and parts subject to pressure .14 46 Human errors .14 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 fault conditions.15 53 Environ

32、mental tests 15 54 General .15 55 Enclosures and covers .15 56 Components and general assembly16 57 Mains parts, components and layout16 58 Protective earthing Terminals and connections .16 59 Construction and layout .16 101 Additional requirements .16 Annex AA (informative) Rationale .19 Annex BB (

33、informative) Environmental aspects22 Annex CC (informative) Index of defined terms.24 Bibliography25 BS EN ISO 18777:2009 ISO 18777:2005(E) ISO 2005 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO memb

34、er 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, government

35、al 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 given in the ISO/IEC Direct

36、ives, 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 least 75 % of the member bodie

37、s 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 18777 was prepared by the European Committee for Standardization (CEN) Technica

38、l 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 between ISO and CEN (Vienna

39、 Agreement). BS EN ISO 18777:2009 ISO 18777:2005(E) vi ISO 2005 All rights reservedIntroduction This International Standard specifies requirements for liquid oxygen systems which are used as a source of supply for oxygen therapy. Annex AA contains a rationale for some of the requirements. It is incl

40、uded to provide additional insight into the committees reasoning that led to a requirement and identifying the hazards that the requirement addresses. Clauses and subclauses marked with * after their number have corresponding rationale contained in Annex AA. This International Standard is a Particul

41、ar 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 the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medic

42、al and patient environment; it also 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/or hazards and apply to all applic

43、able 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 Co

44、llateral 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 following drafting conventions have been applied. This International Standard uses the same main clause titles and numbering as the General

45、 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 specified by the use of the following words. “Replacement” means that the indicated clause or subclause of the General Standard is replaced

46、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, note, table, figure) additional to the General Standard. “Amendment” means that an existing element of the General Standard is parti

47、ally 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, a particular numbering has been employed for elements added by this International Standard: subclauses, tables and figures are number

48、ed 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 print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller r

49、oman type; description of type of document change and test methods: italic type; BS EN ISO 18777:2009 ISO 18777:2005(E) ISO 2005 All rights reserved vii terms defined in the 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 (*). BS EN ISO 18777:2009BS EN ISO 18777:2009 INTERNATIONAL STANDARD ISO 18777:2005(E) ISO 2005 All rights reserved 1Transportable liquid oxygen systems fo