EN ISO 19054-2006 en Rail systems for supporting medical equipment (Incorporates Amendment A1 2016)《支架式医用设备的导轨系统 ISO 19054-2005》.pdf

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1、BRITISH STANDARDBS EN ISO 19054:2006Rail systems for supporting medical equipmentThe European Standard EN ISO 19054:2006 has the status of a British StandardICS 11.040.99g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g4

2、0g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 19054:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006 BSI 2006ISBN 0 580 49145 5National forewordThis British Standard was published by BSI.

3、 It is the UK implementation of The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems.A list of organizations represented on CH/121/6 can be obtained on request to its secretary

4、.This publication does not purport 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.Amendments issued since publicationAmd. No. Date Commentswithdrawn on 1 June 20

5、08.EN ISO 19054:2006. It supersedes BS EN 12218:1999, which will be EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 19054June 2006ICS 11.040.99 Supersedes EN 12218:1998 English VersionRail systems for supporting medical equipment (ISO19054:2005)Systmes de rails de support pour appareils mdicau

6、x (ISO19054:2005)Schienensysteme zum Halten medizinischer Gerte (ISO19054:2005)This European Standard was approved by CEN on 9 June 2006.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

7、standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other

8、 language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France

9、,Germany, Greece, Hungary, Iceland, Ireland, 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 NORMUN

10、GManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 19054:2006: EForeword The text of ISO 19054:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and re

11、spiratory equipment” of the International Organization for Standardization (ISO) and has 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 natio

12、nal standard, either by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by June 2008. This document supersedes EN 12218:1998. This document has been prepared under a mandate given to CEN by the Eu

13、ropean 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, the national standards org

14、anizations 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, Poland, Portugal, Romania, S

15、lovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 19054:2005 has been approved by CEN as EN ISO 19054:2006 without any modifications. EN ISO 19054:2005Reference numberISO 19054:2005(E)INTERNATIONAL STANDARD ISO19054First edition2005-07-01Rail system

16、s for supporting medical equipment Systmes de rails de support pour quipement mdical EN ISO 19054:2005ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 General Requirements 4 4.1 Safety . 4 4.2 * Alternative construction 4 4.3 Material

17、s 4 4.4 Electrical requirements 4 5 Rail system requirements 4 5.1 Rail supports . 4 5.2 Rail 4 5.3 Joining of rails 9 5.4 Rail clamp 9 5.5 Equipment mount holder . 11 5.6 Equipment mount . 12 5.7 Equipment mount pin holder. 13 5.8 Equipment mount pin. 14 5.9 * Mechanical characteristics of the rail

18、 after installation . 14 6 Marking, labelling and packaging . 15 7 Testing, commissioning and certification16 7.1 Tests after installation 16 7.2 Certification of the installed rail system. 16 8 Information to be supplied by the manufacturer. 16 8.1 Upon delivery of rail and supports . 16 8.2 Upon d

19、elivery of other components of the rail system 17 Annex A (informative) Example of a form for certification of the rail system 18 Annex B (informative) Rationale .19 Annex C (informative) Special national and regional conditions for electrical installations . 20 Bibliography . 21 EN ISO 19054:2005Re

20、quirements of EU Directive 93/42/EEC Medical devices 22 (informative)Annex ZA Relationship between this European Standard and the Essentialiv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep

21、aring 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, governmental and non-governmental, in

22、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 Directives, Part 2. The main task

23、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 bodies casting a vote. Attention

24、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 19054 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee S

25、C 6, Medical gas systems. EN ISO 19054:2005vIntroduction This International Standard specifies basic requirements and dimensions for rail systems used for supporting medical equipment. A rail system consists of a number of components that can be assembled into different configurations. Rail systems

26、allow medical equipment such as flowmeters, suction devices and luminaires to be placed near the patient. They can be mounted in many different locations in health care facilities and in ambulances and other means of transportation and on many different pieces of equipment such as medical supply uni

27、ts, ceiling pendants, trolleys, beds, ventilators and anaesthetic workstations. Medical equipment can be attached to a rail by rail clamps directly or using other components of dimensions which are specified in this International Standard. Rail clamps are required to be compatible with rails which h

28、ave dimensions specified in this International Standard. Rail systems have to be fitted to different kinds of load-bearing structures which 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 patie

29、nt. Patients with accompanying medical equipment are frequently moved either to or within health care facilities. Lack of standardization 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 sta

30、tements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. The clauses and subclauses marked with an asterisk (*) aft

31、er their number have corresponding rationale contained in Annex B. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. EN ISO 19054:2005blank1Rail systems for s

32、upporting medical equipment 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 spe

33、cifications for rail systems include dimensions, strength and information to be supplied by the manufacturer. This International Standard applies only to rail systems intended to be mounted horizontally. This International Standard does not specify either the structures to which a rail system can be

34、 attached or the types of medical equipment that can be supported. This International Standard does not apply to overhead rail systems for supporting curtains and infusion devices. NOTE 1 Some medical equipment can be attached to the rail by means that are outside the scope of this International Sta

35、ndard. NOTE 2 It is expected that particular standards will be prepared to cover applications for which the rail systems specified in this International Standard are unsuitable. 2 Normative references The following referenced documents are indispensable for the application of this document. For date

36、d references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1302:2002, Geometrical Product Specifications (GPS) Indication of surface texture in technical product documentation ISO 4135:2001, Anaesthetic

37、and respiratory equipment Vocabulary ISO 6506-1:1999, Metallic materials Brinell hardness test Part 1: Test method ISO 14971:2000, Medical devices Application of risk management to medical devices EN 980, Graphical symbols for use in the labelling of medical devices 3 Terms and definitions For the p

38、urposes of this document, the terms and definitions given in ISO 4135 and the following apply. 3.1 commissioning proof of function to verify that the agreed system specification is met and is accepted by the user or the representative of the user EN ISO 19054:20052 3.2 equipment mount component of a

39、 rail system used to attach medical equipment to an equipment mount holder (See Figure 1) 3.3 equipment mount holder component of a rail system to which an equipment mount can be attached and removed (See Figure 1) 3.4 equipment mount pin component of a rail system used to attach medical equipment t

40、o an equipment mount pin holder (See Figure 1) 3.5 equipment mount pin holder component of a rail system to which an equipment mount pin can be attached and removed (See Figure 1) 3.6 installer person with legal responsibility for the installation of a device 3.7 locking mechanism part of the rail c

41、lamp used to lock and unlock the rail clamp to and from the rail contact area 3.8 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are

42、 carried out by that person himself or on his behalf by a third party 3.9 rail bar on which medical equipment can be attached or removed by use of a rail clamp 3.10 rail clamp means of attaching or removing medical equipment or an equipment mount holder or an equipment mount pin holder to or from a

43、rail 3.11 rail clamp contact area part of a rail clamp intended for direct contact with the rail 3.12 rail contact area part of a rail intended for direct contact with the rail clamp contact area and the locking mechanism 3.13 rail end cap component that is attached to the end of the rail and is int

44、ended to stop a clamp from sliding off the rail EN ISO 19054:200533.14 rail support component of a rail system used to attach a rail to a structure or equipment (See Figure 1) 3.15 rail system assembly of components comprising at least a rail, rail supports and rail clamps (See Figure 1) 3.16 single

45、 fault condition condition in which a single means of protection against a hazard in equipment is defective or a single external abnormal condition is present Key 1 load-bearing structure 2 rail support 3 rail 4 rail clamp 5 equipment mount 6 equipment mount holder 7 medical equipment 8 equipment mo

46、unt pin holder 9 equipment mount pin 10 permanent connection 11 operator connection Figure 1 Examples of connections of medical equipment to a rail system EN ISO 19054:20054 4 General Requirements 4.1 Safety Rail systems shall, when installed, operated and maintained according to the instructions of

47、 the manufacturer, cause no safety hazard which could be foreseen using risk management procedures in accordance with ISO 14971. NOTE Components that ensure compatibility between a rail system and medical equipment can be provided by different manufacturers. 4.2 * Alternative construction Rail syste

48、ms using materials or having forms of construction different from those detailed in this International Standard shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. Evidence shall be made available by the manufacturer upon request. 4.3 Materials 4.3.1 * The ma

49、terials shall be resistant to corrosion and compatible with the cleaning and disinfecting products and procedures recommended by the manufacturer. Evidence shall be made available by the manufacturer upon request. 4.3.2 The materials shall allow the rail system to comply with the requirements in Clause 5. 4.4 Electrical requirements The rail system shall be connected to the equipotential bonding installation if required by national or regional regulations. The relevant parts of national or regional regulations for electrical installations in buildings s