BS EN 15154-3-2009 Emergency safety showers - Non plumbed-in body showers《应急安全性淋浴器 非管路接入式全身淋浴器》.pdf

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1、BSEN15154-3:2009ICS 13.100; 71.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISHSTANDARDEmergencysafetyshowersPart3:Nonplumbed-inbodyshowersThisBritishStandardwas publishedundertheauthorityoftheStandardsPolicy and StrategyCommittee on31 August2009BSI2009ISBN97805805

2、88471Amendments/corrigendaissuedsincepublicationDate CommentsBSEN15154-3:2009NationalforewordThisBritish Standardisthe UKimplementationofEN15154-3:2009.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeLBI/18,Laboratoryfurnitureandfittings.Alistof organizationsrepresentedonthiscommit

3、teecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.BS EN 15154-3:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 15

4、154-3March 2009ICS 71.040.10English VersionEmergency safety showers - Part 3: Non plumbed-in bodyshowersDouches de scurit - Partie 3: Douches pour le corps nonraccordes au rseau deauSicherheitsnotduschen - Teil 3: Krperduschen ohneWasseranschlussThis European Standard was approved by CEN on 21 Febru

5、ary 2009.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 standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtain

6、ed 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management

7、 Centre has the same status as theofficial 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, Pol

8、and, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any m

9、eans reservedworldwide for CEN national Members.Ref. No. EN 15154-3:2009: EBS EN 15154-3:2009EN 15154-3:2009 (E)2 Contents PageForeword 3Introduction .41Scope 52Normative references53Terms and definitions .54Performance requirements .64.1 Efficacy .64.2 Quality of washing fluid 64.3 Flow .64.4 Conta

10、iner for washing fluid 75Functional Requirements75.1General . .75.2 Single use bodyshowers 75.3 Multiple use body showers .85.4 Refillable body showers86Information for use86.1 Labelling and marking.86.2 Further information and instructions for use to be supplied9Bibliography . 10BS EN 15154-3:2009E

11、N 15154-3:2009 (E)3 Foreword This document (EN 15154-3:2009) has been prepared by Technical Committee CEN/TC332 “Laboratory equipment”, the secretariat of which isheld by DIN.This European Standard shall be given the status ofa national standard, either by publication of an identical text or by endo

12、rsement, at the latest by September 2009, and conflicting national standards shall bewithdrawn at the latest by September 2009.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 id

13、entifying any orall such patent rights. EN 15154 consists of the following parts, under the general title Emergency safety showers Part 1: Plumbed-in body showers for laboratories Part 2: Plumbed-in eyewash units Part 3: Non plumbed-in body showers Part 4: Non plumbed-in eyewash units Part 5: Plumbe

14、d-in body showers for production facilities (in planning)According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Fran

15、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. BS EN 15154-3:2009EN 15154-3:2009 (E)4 Introduction The first seconds after an accid ent i

16、nwhich the bodyor parts of the body have been expo sed to harmfulsubstances or heat are critical to keep the injury toa minimum. Non plumbed-in emergency safety bodyshowers are designed and intended to be kept in the immediate proximity of persons working in a potentiallyhazardous area. The main pur

17、pose of these devices is to supply immediate first aid.Non plumbed-in emergencysafetybody showers can also allow continued washing on the wayto medical care.BS EN 15154-3:2009EN 15154-3:2009 (E)5 1 ScopeThis European Standardis a product specification, giving minimum performance requirements for non

18、plumbed-in emergencysafety bodyshowers.It is applicable to body showers filled with a washing fluid by the manufacturer and to empty devices to be filled prior to putting into se rvice. Both variations are f or first aid use when the body or parts of the body have been exposed to harmful substances

19、orheat.Requirements are alsogiven concerning labelling, marking and information to be supplied by the manufacturer.Throughout this standard, the term “non plumbed-in emergency safety body shower” is referred to as “bo dyshower”.2 NormativereferencesThe following referenced documents are indispensabl

20、e for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.EN 556-1, Sterilization of medical devices Requirements for medical devices to be designated “ STERILE“

21、 Part 1: Requirements for terminally sterilized medicaldevices EN 556-2, Sterilization of medical devices Requirements for medical devices to be designa ted “ STERILE“ Part 2: Requirements for aseptically processed medical devicesEN 980, Symbols for use in the labelling of medical devicesEN 1041, In

22、formation supplied by the manufacturer of medical devices3 Terms and definitions For the purposes of this document, the following terms and definitions apply.3.1non plumbed-in body showerself contained device speciallydesigned to reduce the amount of harmful substances orheat bya cascadingor sprayin

23、g of washing fluid on the body or parts of the body 3.2fixed body showernon plumbed-in body shower which is designed to be in a fixed and stationary position3.3transportable body showernon plumbed-in body shower that is a movable device3.4portable bodyshowernon plumbed-in body shower that is designe

24、d to be carried by a single person unaided and kept or mountedinthe immediate proximity of the user to supply immediate washingBS EN 15154-3:2009EN 15154-3:2009 (E)6 3.5single use body showernon plumbed-in body shower designed to deliver a single application of washing fluid3.6multiple use body show

25、er non plumbed-in body shower designed to deliver multiple applications of washing fluid3.7refillable bodyshower non plumbed-in body shower designed to be refilled after use3.8effective volume minimum volume of fluid that can be dispensed from the unit during intended operation4 Performance requirem

26、ents 4.1 EfficacyThe efficacyof the product shall be sufficient to reduce the effects of harmful substances and/or heat.4.2Qualityof washing fluid 4.2.1 GeneralThe washing fluid shall be non toxic and safe for the user during the entire shelf life of the product.The washing fluid shall be water or s

27、olutions.4.2.2 WaterIf water is used in body showers, it shall be potable water orwater of a similar quality.NOTE Potable water is defined in the European Directive 98/83/EC.4.2.3 SolutionsIf saline solutions, buffered solutions or other solutions are used in body showers, the solutions shall be ste

28、rile according to EN 556-1 or EN 556-2.NOTE Attention is drawn to European Directive MDD 93/42/EEC.4.3 FlowBody showers shall be designed to provide a controlled flow of washing fluid to any portion of the body at a velocity low enough to be non injurious.The flow pattern and the volume shall ensure

29、 proper washing/heat reduction according to the manufacturersspecified field of application.BS EN 15154-3:2009EN 15154-3:2009 (E)7 4.4 Container forwashing fluid4.4.1 GeneralBody showers shall be designed in such a way as to be non hazardous to the user. Materials used in the construction of body sh

30、owers shall not affect the quality of the fluid nor shall the fluidaffect the materials of the container during the shelf life of the product.The effective volume of body showers shall be sufficient to provide immediate washing while further fluid isobtained, if necessary.NOTE The European Directive

31、 PED 97/23/EC can apply for certain pressurised units.4.4.2 Fixed body showersThe minimum effective volume shall be 100 l for water. Fixed body showers containing other solutions shallhave an effective volume to achieve at least equivalent efficacy, which shall be proven by the manufacturer.4.4.3 Tr

32、ansportable body showersTransportable body showers shall be fitted with wheels/rollers/othersin order to be easily handled and moved.If wateris used, the minimum effective volume shall be 15 l. Transportable body showers containing othersolutions shall have an effective volume to achieve at least eq

33、uivalent efficacy, which shall be proven by themanufacturer.4.4.4 Portable body showersPortable body showers shall have a mass of less than 15 kg. The y shall be designed to allow the user to firmlygrip the unit.If water is used, the minimum effective volume shall be 10 l. Portablebody showers conta

34、ining other solutionsshall have an effective volume to achieve at least equivalent efficacy, which shall be proven by the manufacturer.Portable body showers specifically designed for he at reduction of thermal burnsmay havean effective volumeof less than 10 l and shall be marked accordingly (see 6.1

35、 j). 5 Functional Requirements 5.1 General Body showers shall be able to be activated for immediate use by a single person within a maximum of 5 s.If the unit is intended to be handheld, the shower shall allow the user to distribute the washing fluid with one hand.Once the shower has been activated,

36、 it shall be possible to temporarilydeactivate it, to save washing fluid.5.2Single use body showers Single use body showers shall be fitted with a tamper-evident device.BS EN 15154-3:2009EN 15154-3:2009 (E)8 5.3Multiple use body showersThe device shall be designed so that it can be checked that it i

37、s fit and ready for use.Productswhich are to beused on different casualties shall be designed to prevent cross contamination orinfection.5.4Refillable body showers The device shall be designed so that it can be checked that it is fit and ready for use.Refillable body showers shall be fitted with a t

38、amper-evident device.It shall be possible to mark/remark refillable body showers with the filling date and the expiry date and to resetor replace the tamper-evident device.Every refilling/reconditioning process shall be designed to prevent cross contamination or infection and maintain the initial ef

39、ficiencylevel.The unit shall be designed to enable thorough cleaning. 6Information for use 6.1Labelling and markingBody showers shall be labelled and marked in accordance wit h EN 1041 and EN 980.Body showers shall be clearly and permanently marked w ith at least the following information: a) the na

40、me or trade name and address of the manufacturer,b) the details strictlynecessary for the user to identify the product and the content of the packaging,c) the word/symbol STERILE and method of sterilization, where appropriate,d) the batch code, preceded bythe word/symbol LOT, where appropriate,e) th

41、e symbol of hour glass YYYY/MM (for refillable devices the expirydate for the content shall bestated YYYY/MM/DD),f) the symbol to indicate that the product is for single use, where appropriate,g) any special storage and/or handling conditions,h) any special operating instructions,i) anywarnings and/

42、or precautions to take, including contraindications,j) the intended purpose of the product,k) the effective volume.BS EN 15154-3:2009EN 15154-3:2009 (E)9 6.2Further information and instructions for use to be suppliedWhere information required to use the product safely can not be included on the prod

43、uct label, this informationshall be provided separately.This information shall include:a) all the items listed in 6.1 with the exception of expiry date, batch code and compliance to this European Standard for only heat reduction of thermal burns,b) a clear procedure for use of the product to reduce

44、harmful substances or cool thermal burns and furtherprocedures to obtain a harmless level,c) any chemical groups or specific chemicals that the unit is designed to decontaminate, where applicable,d) any contraindications,e) advice about placing the unit on a clearlyvisible and/or accessible location

45、, within easy reach and in theimmediate proximity of the risk source,f) information on installation and m aintenance, if applicable,g) if refill is possible, cleaning and refilling instructions to secure the initial efficiency and safety in accordance with 4.2,h) intended means for transportation, i

46、f assigned as transportable body shower,i) explanation of the symbolsused in accordance with EN 980.BS EN 15154-3:2009EN 15154-3:2009 (E)10 Bibliography1 98/83/EC, Council Directive 98/83/EC of 3 November 1998 relating to the quality of water intended forhuman consumption 2 93/42/EEC, Council Direct

47、ive 93/42/EEC of 14 June 1993 concerning medical devices3 97/23/EC, Directive 97/23/EC of the European Parliament and of the Council of 29 May1997 on the approximation of the laws of the Member States concerning pressure equipment BS EN 15154-3:2009This page has been intentionally left blank BSEN151

48、54-3:2009BSIGroupHeadquarters389ChiswickHighRoad,London,W44AL,UKTel+44(0)2089969001Fax+44(0) -British Standards InstitutionBSIistheindependentnationalbodyresponsibleforpreparingBritishStandards.ItpresentstheUKviewonstandardsinEuropeandattheinternationallevel.ItisincorporatedbyRoyalCharter.RevisionsB

49、ritishStandardsareupdatedbyamendmentorrevision.UsersofBritishStandardsshouldmakesurethattheypossessthelatestamendmentsoreditions.ItistheconstantaimofBSItoimprovethequalityofourproductsandservices.WewouldbegratefulifanyonefindinganinaccuracyorambiguitywhileusingthisBritishStandardwouldinformtheSecretaryofthetechnicalcommitteeresponsible,theidentityofwhichcanbefou