DIN EN ISO 19054-2017 Rail systems for supporting medical equipment (ISO 19054 2005 + Amd1 2016) German version EN ISO 19054 2006 + A1 2016《医疗设备辅助用轨道系统(ISO 19054-2005+Amd 1-2016) 德.pdf

1、April 2017 English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.99!%dV.“2655111www.din.deDI

2、N EN ISO 19054Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016);English version EN ISO 19054:2006 + A1:2016,English translation of DIN EN ISO 19054:2017-04Schienensysteme zum Halten medizinischer Gerte (ISO 19054:2005 + Amd1:2016);Englische Fassung EN ISO 19054:2006 + A1:201

3、6,Englische bersetzung von DIN EN ISO 19054:2017-04Systmes de rails de support pour appareils mdicaux (ISO 19054:2005 + Amd1:2016);Version anglaise EN ISO 19054:2006 + A1:2016,Traduction anglaise de DIN EN ISO 19054:2017-04SupersedesDIN EN ISO 19054:200609www.beuth.deDocument comprises 33 pagesDTran

4、slation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17 DIN EN ISO 19054:2017-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 19054:2006 + A1:2016) has been prepared by Technical Committee ISO/TC 121 “An

5、aesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat; BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committe

6、e Rescue Services and Hospital), Working Committee NA 053-03-06 AA “Central gas supply systems”. This standard includes Corrigendum 1, approved by CEN on 30 November 2016. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards correspon

7、ding to the International Standards referred to in this document are as follows: ISO 1302:2002 DIN EN ISO 1302:2002-06 ISO 4135:2001 DIN EN ISO 4135:2002-03 ISO 6506-1:1999 DIN EN ISO 6506-1:1999-10 ISO 14971:2000 DIN EN ISO 14971:2001-03 Amendments This standard differs from DIN EN ISO 19054:2006-0

8、9 as follows: a) in subclause 5.2.6, the determination of the surface hardness of rails has been rendered more precise; the value of the Brinell hardness shall be 70 HBW 2,5/62,5; b) the rationale for subclauses 5.2.5, 5.2.6, 5.2.7, 5.2.8, 5.4.7, 5.5.2, 5.6.2, 5.7.2 and 5.8.2 which had been containe

9、d in the fourth paragraph of Annex B has been deleted and a rationale for 5.2.6 has been included; c) Annex ZA has been editorially revised. Previous editions DIN EN 12218: 1998-12, 2002-07 DIN EN ISO 19054: 2006-09 DIN EN ISO 19054:2017-04 3 National Annex NA (informative) Bibliography DIN EN ISO 1

10、302:2002-06, Geometrical Product Specifications (GPS) Indication of surface texture in technical product documentation (ISO 1302:2002) DIN EN ISO 4135:2002-03, Anaesthetic and respiratory equipment Vocabulary (ISO 4135:2001) DIN EN ISO 6506-1:1999-10, Metallic materials Brinell hardness test Part 1:

11、 Test method (ISO 6506-1:1999) DIN EN ISO 14971:2001-03, Medical devices Application of risk management to medical devices (ISO 14971:2000) DIN EN ISO 19054:2017-04 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19054 June 2006 +A1 December 2016 ICS 11.04

12、0.99 English Version Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016) Systmes de rails de support pour appareils mdicaux (ISO 19054:2005 + Amd1:2016) Schienensysteme zum Halten medizinischer Gerte (ISO 19054:2005 + Amd1:2016) This European Standard was approved by CEN on 9

13、June 2006 and Amendment 1 on 30 November 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerni

14、ng such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This amendment 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 l

15、anguage and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gre

16、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG

17、CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19054:2006 + A1:2016 EEN ISO 19054:2006 + A1:2016 (E) 2 Contents Page European foreword . 3 !European forewor

18、d to Amendment A1 . 4 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be covered . 5 Introduction 6 1 Scope 7 2 Normative references 7 3 Terms and definitions . 7 4 General Requirements . 10 4.1 Safety 10

19、4.2 * Alternative construction. 11 4.3 Materials 11 4.4 Electrical requirements . 11 5 Rail system requirements . 11 5.1 Rail supports 11 5.2 Rail . 11 5.3 Joining of rails . 16 5.4 Rail clamp . 17 5.5 Equipment mount holder 19 5.6 Equipment mount 20 5.7 Equipment mount pin holder 21 5.8 Equipment m

20、ount pin . 22 5.9 * Mechanical characteristics of the rail after installation . 22 6 Marking, labelling and packaging 23 7 Testing, commissioning and certification . 24 7.1 Tests after installation . 24 7.2 Certification of the installed rail system 24 8 Information to be supplied by the manufacture

21、r . 25 8.1 Upon delivery of rail and supports 25 8.2 Upon delivery of other components of the rail system 25 (informative) Example of a form for certification of the rail system 26 Annex A(informative) Rationale . 27 Annex B(informative) Special national and regional conditions for electrical instal

22、lations . 28 Annex CBibliography . 29 DIN EN ISO 19054:2017-04 EN ISO 19054:2006 + A1:2016 (E) 3 European foreword The text of ISO 19054:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and ha

23、s been taken over as EN ISO 19054:2006 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 late

24、st by December 2006, and conflicting national standards shall be withdrawn at the latest by Juni 2008. This document supersedes EN 12218:1998. This document has been prepared under a standardization request given to CEN by the European Commission and the European Free Trade Association, and supports

25、 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, the national standards organizations of the following countries are bound to implement this Euro

26、pean Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slo

27、venia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19054:2005 has been approved by CEN as EN ISO 19054:2006 without any modification. DIN EN ISO 19054:2017-04 EN ISO 19054:2006 + A1:2016 (E) 4 !European foreword to Amendment A1 This document (EN ISO

28、19054:2006/A1:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI This Amendment to the European Standard EN ISO 19054:20

29、06 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. Attention is drawn to the possibility that some of the elements of this doc

30、ument 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requireme

31、nts 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, the national standards organizations of the following countries are bound to implement this European Standard: Austr

32、ia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

33、, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19054:2005/Amd1:2016 has been approved by CEN as EN ISO 19054:2006/A1:2016 without any modification.“ DIN EN ISO 19054:2017-04 EN ISO 19054:2006 + A1:2016 (E) 5 Annex ZA (informative) !Relationship between this European

34、 Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European Standards related to medical devices / M/295 concerning the development of

35、 European Standards related to medical devices / reference number and title of any other standardization request as relevant to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 160.N1)Once this standard

36、 is cited in the Official Journal of the European Union under that Directive, compliance with the normative 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 Directi

37、ve and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced “as far as possible”,

38、“to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Direc

39、tive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table

40、 ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 5.2.6 Partly covered WARNING 1 Presumption of conformity stays valid only as long as a reference to this

41、European Standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling w

42、ithin the scope of this standard.“ N1)National footnote: Essential requirements of the EU Directive 93/42/EEC OJ L 169 to be covered are meant here. DIN EN ISO 19054:2017-04 EN ISO 19054:2006 + A1:2016 (E) 6 Introduction This International Standard specifies basic requirements and dimensions for rai

43、l systems used for supporting medical equipment. A rail system consists of a number of components that can be assembled into different configurations. Rail systems allow medical equipment such as flowmeters, suction devices and luminaires to be placed near the patient. They can be mounted in many di

44、fferent locations in health care facilities and in ambulances and other means of transportation and on many different pieces of equipment such as medical supply units, ceiling pendants, trolleys, beds, ventilators and anaesthetic workstations. Medical equipment can be attached to a rail by rail clam

45、ps directly or using other components of dimensions which are specified in this International Standard. Rail clamps are required to be compatible with rails which have dimensions specified in this International Standard. Rail systems have to be fitted to different kinds of load-bearing structures wh

46、ich can vary from solid concrete walls or thin plasterboard partitions to the covers of medical equipment. This can create hazards to the equipment and to the patient. Patients with accompanying medical equipment are frequently moved either to or within health care facilities. Lack of standardizatio

47、n of rail systems in different locations can create hazardous situations in the transfer of the patient from one location to another. Annex B contains rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning tha

48、t led to the requirements and recommendations that have been incorporated in this International Standard. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex B. It is considered that knowledge of the reasons for the requirements w

49、ill not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. DIN EN ISO 19054:2017-04 EN ISO 19054:2006 + A1:2016 (E) 7 1 Scope This International Standard specifies basic requirements to ensure compatibility between rail systems complying with this International Standard and medical equipment in order to facilitate the transfer of medical equipment from one rail system to another. The specificati