1、BSEN15154-4:2009ICS 13.100; 71.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISHSTANDARDEmergencysafetyshowersPart4:Nonplumbed-ineyewashunitsThisBritishStandardwas publishedundertheauthorityoftheStandardsPolicy and StrategyCommittee on31 August2009BSI2009ISBN 978058
2、0 58848 8Amendments/corrigenda issued sincepublicationDate CommentsBS EN 15154-4:2009National forewordThisBritish Standardisthe UKimplementationofEN15154-4:2009.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeLBI/18,Laboratoryfurnitureandfittings.Alistof organizationsrepresentedont
3、hiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.Compliance withaBritish Standard cannotconfer immunityfrom legal obligations.BS EN 15154-4:2009EUROPEAN STANDARDNORME EUROPENNEEUROP
4、ISCHE NORMEN 15154-4March 2009ICS 71.040.10English VersionEmergency safety showers - Part 4: Non plumbed-in eyewashunitsDouches de scurit - Partie 4: Units de lavage dyeuxnon raccordes au rseau deauSicherheitsnotduschen - Teil 4: Augenduschen ohneWasseranschlussThis European Standard was approved by
5、 CEN on 21 February 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 nationalstandar
6、ds 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 translationunder the responsibility of a CEN member into its own language and notified to th
7、e CEN Management 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, Netherla
8、nds, Norway, Poland, 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 f
9、orm and by any means reservedworldwide for CEN national Members.Ref. No. EN 15154-4:2009: EBS EN 15154-4:2009EN 15154-4:2009 (E)2 Contents PageForeword 3Introduction .41Scope 52Normative references53Terms and definitions .54Performance requirements .64.1 Efficacy .64.2 Quality of rinsing fluid .64.3
10、 Flow .64.4 Container for rinsing fluid.75Functional Requirements75.1General . .75.2 Single use eyewash units.75.3 Multiple use eyewash units 75.4 Reconditionable eyewash units .86Information for use86.1 Labelling and marking.86.2 Further information and instructions for use to be supplied8Bibliogra
11、phy . 10BS EN 15154-4:2009EN 15154-4:2009 (E)3 Foreword This document (EN 15154-4:2009) 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 a
12、n identical text or by endorsement, 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
13、 be held responsible for identifying 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 e
14、yewash units Part 5: Plumbed-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, Denm
15、ark, 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 UnitedKingdom. BS EN 15154-4:2009EN 15154-4:2009 (E)4 Introduction The first s
16、econds after an accident inwhich the eyes have been ex posed to harmful substances are critical tokeep the eye injuryto ami nimum. Non plumbed-in emergency safety eyewash units are designed and intended to be kept in the immediate proximity of persons working in a potentially hazardous area. The mai
17、n purpose of these devices is to supply immediate primary flushing.Non plumbed-in emergency safety eyewash units can also allow continued flushing on the way to medical care.BS EN 15154-4:2009EN 15154-4:2009 (E)5 1 ScopeThis European Standardis a product specification, giving minimum performance req
18、uirements for nonplumbed-in emergencysafety eyewash units.It is applicable to non plumbed-in emergency safetyeyewash units fi lled with a rinsing fluid by the manufacturer for first aid use w hen the eyes have been exposed to h armful substances. Requirements are alsogiven concerning labelling, mark
19、ing and information to be supplied by the manufacturer.Throughout this standard, the term “non plumbed-in emergency safety eyewash unit” is referred to as“eyewash unit“.2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences
20、, 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“ Part 1: Requirements for terminally sterilized medicaldevic
21、es 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, Information supplied by the manufacturer of medical devices3 Te
22、rms and definitions For the purposes of this document, the following terms and definitions apply.3.1non plumbed-in eyewash unit self contained device specially designed and intended to deliver a flushing fluid to irrigate and flush the eye(s)when exposed to harmful substances3.2transportable eyewash
23、 unitnon plumbed-in eyewash unit that is a movable device3.3portable eyewash unitnon plumbed-in eyewash unit thatis designed to be carried bya single person unaided and kept or mountedin immediate proximity of the user to supply immediate flushing3.4personal eyewash unit non plumbed-in eyewash unit
24、that is designed to be carried by and on the user, in a pocket or a holster3.5single use eyewash unitnon plumbed-in eyewash unit designed to deliver a single application of rinsing fluidBS EN 15154-4:2009EN 15154-4:2009 (E)6 3.6multiple use disposable eyewash unitnon plumbed-in eyewash unit designed
25、 to deliver multiple applications of rinsing fluid prior to disposalEXAMPLE Pressurised spray-cans.3.7reconditionable eyewash unit non plumbed-in eyewash unit designed to be reconditioned3.8effective volume minimum volume of fluid that can be dispensed from the unit during intended operation4 Perfor
26、mance requirements 4.1 EfficacyThe efficacyof the product shall be sufficient to reduce the effects of harmful substances.4.2Quality of rinsing fluid4.2.1 GeneralThe rinsing fluid shall be non toxic and safe for the user during the entire shelf life of the product.The rinsing fluid shall be water or
27、 solutions.4.2.2 WaterIf water is used in eyewash units, it shall be potable water orwater of a s imilar quality,wherein germmultiplication is prevented.NOTE Potable water is defined in the European Directive 98/83/EC.4.2.3 SolutionsIf saline solutions, buffered solutions orother solutions are used
28、in eyewash units,the solutions shall be sterileaccording to EN 556-1 or EN 556-2.NOTE Attention is drawn to European Directives MDD 93/42/EEC and Medicine products 2001/83/EC.4.3 FlowThe flow pattern shall ensure rinsing of the entire area of the eye(s) including the eyelids.The design of eyewash un
29、its shall ensure that the pressure of the fluid at the point of deliveryis minimised soas not to cause injuryto the eye.The design of the device shall allow for continuous flow of the rinsing fluid.BS EN 15154-4:2009EN 15154-4:2009 (E)7 4.4Container for rinsing fluid 4.4.1 GeneralEyewash units shall
30、 be designed in such a way as to be non hazardous to the user. Materials used in the construction of eyewash units shall not affect the qualityof the fluid nor shall the fluid affect the materials of the container during the shelf life of the product.NOTE 1 The European Directive PED 97/23/EC can ap
31、ply for certain pressurised units.NOTE 2The number of eyewash units positioned in any work place location can bedetermined bythe risk assessmentfor that location.4.4.2 Transportable eyewash unitsTransportable eyewash units with a mass between 2 kg and 15 kg shall have handles or shall be able to be
32、moved with a transport tool intended for this. With a mass greater than 15 kg, they shall be fittedwith wheels if theyare intended to be moved bya single person.4.4.3 Portable eyewash unitsPortable eyewash units shall have a mass less than 2 kg. They shall bedesigned to allow the userto firmlygrip t
33、he unit with one hand.The minimum effective volume shall be 400 ml for water.Portable eyewash units containing other solutionsshall have an effective volume to achieve at least equivalent efficacy.4.4.4 Personal eyewash unitsThe effective volume of personal eyewash units shall be sufficient to provi
34、de immediate flushing while furtherfluid is obtained.The minimum effective volume shall be 150 ml for water.Personal eyewash units containing other solutions shall have an effective volume to achieve at least equivalent efficacy.The design of the personal eyewash unit shall allow it to be carried in
35、 a pocket or a holster without hindering movement during work. 5 Functional Requirements 5.1 General Eyewash units shall be able to be activated for immediate use by a single person within a maximum of 5 s,evenwith closed eyes. Once activated, it shall be possible to operate the device with one hand
36、.5.2Single use eyewash unitsSingle use eyewash units shall be fitted with a tamper-evident device.5.3Multiple use eyewash unitsThe device shall be designed so that it can be checked that it is fit and ready for use.BS EN 15154-4:2009EN 15154-4:2009 (E)8 Products which are to beused on different casu
37、alties shall be designed to prevent cross contamination orinfection.Multiple use eyewash units shall be fitted with a tamper-evident device.5.4Reconditionable eyewash unitsThe device shall be designed to be rec onditioned only bythe manufacturer or authorized service agents.The design shall allowthe
38、 deviceto be checked to ensure that it is fit and ready for use. The unit shall befitted with a tamper-evident device.It shall be possible to mark/remark reconditioned eyewash units with the reconditioning date and the expirydate.Every reconditioning process shall be designed to prevent cross contam
39、ination or infection.6Information for use 6.1Labelling and markingEyewash units shall be labelled and marked in accordance with EN 1041 and EN 980.Eyewash units shall be clearly and permanently marked with at least the following information:a) the name or trade name and address of the manufacturer,b
40、) 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) the symbol of hour glass expired date expressed as Y
41、YYY/MM,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/or precautions to take, including contraindications,j) intended purpose of the product, k) the effective v
42、olume,l) the wording “Reconditioning onlyby the manufacturer or authorized service agents.”, where appropriate.6.2Further information and instructions for use to be suppliedWhere information required to use the product safely can not be included on the product label, this informationshall be provide
43、d separately.BS EN 15154-4:2009EN 15154-4:2009 (E)9 This information shall include:a) all the items listed in 6.1 with the exception of expirydate and batch code,b) a clear procedure for use of the product to reduce harmful substances and further procedures to obtain aharmless level,c) any chemical
44、groups or specific chemicals that the unit is designed to decontaminate, if applicable,d) advice about placing the unit on a clearlyvisible and/or accessible location, within easyreach and in theimmediate proximity of the risk source,e) information on installation and maintenance, if applicable,f) c
45、ontact information regarding the reconditioning of the device, if applicable,g) explanation of the symbolsused in accordance with EN 980.BS EN 15154-4:2009EN 15154-4:2009 (E)10 Bibliography1 98/83/EC, Council Directive 98/83/EC of 3 November 1998 relating to the quality of water intended forhuman co
46、nsumption 2 93/42/EEC, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices3 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Communitycode relating to medicinal products for human use 4 97/23/EC, Directive 97/23/EC of the European Parliament and o
47、f the Council of 29 May1997 on the approximation of the laws of the Member States concerning pressure equipment BS EN 15154-4:2009This page has been intentionally left blank BSEN15154-4:2009BSIGroupHeadquarters389ChiswickHighRoad,London,W44AL,UKTel+44(0)2089969001Fax+44(0) -British Standards Institu
48、tionBSIistheindependentnationalbodyresponsibleforpreparingBritishStandards.ItpresentstheUKviewonstandardsinEuropeandattheinternationallevel.ItisincorporatedbyRoyalCharter.RevisionsBritishStandardsareupdatedbyamendmentorrevision.UsersofBritishStandardsshouldmakesurethattheypossessthelatestamendmentso
49、reditions.ItistheconstantaimofBSItoimprovethequalityofourproductsandservices.WewouldbegratefulifanyonefindinganinaccuracyorambiguitywhileusingthisBritishStandardwouldinformtheSecretaryofthetechnicalcommitteeresponsible,theidentityofwhichcanbefoundontheinsidefrontcover.Tel:+44(0)2089969000.Fax:+44(0)2089967400.BSIoffersmembersanindividualupdatingservicecalled
