1、July 2009DEUTSCHE NORM English price group 8No part of this standard 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 71.040.10!$Xl_“1537360www.
2、din.deDDIN EN 15154-4Emergency safety showers Part 4: Non plumbed-in eyewash unitsEnglish version of DIN EN 15154-4:2009-07Sicherheitsnotduschen Teil 4: Augenduschen ohne WasseranschlussEnglische Fassung DIN EN 15154-4:2009-07SupersedesDIN 12930:1995-12www.beuth.deDocument comprises 12 pagesDIN EN 1
3、5154-4:2009-07 2 Start of validity This standard takes effect on 1 July 2009. National foreword This standard includes safety requirements within the meaning of the Gerte- und Produktsicherheitsgesetz (GPSG) (German Equipment and Consumer Goods Safety Law). This standard has been prepared by Technic
4、al Committee CEN/TC 332 “Laboratory equipment” (Secretariat: DIN, Germany), Working Group WG 6 “Portable emergency shower devices”. The responsible German body involved in its preparation was the Normenausschuss Laborgerte und Laboreinrichtungen (Laboratory Equipment Standards Committee), Technical
5、Committee NA 055-02-03 AA Laborarmaturen. This European Standard is a product standard (see clause 1) containing requirements and test methods addressed to manufacturers of emergency safety showers. In Germany, the operation of emergency safety showers in laboratories is governed by the technical ru
6、les TRGS 526 and BGI/GUV-I 850-0 (see National Annex NA below). Rinsing fluids, e.g. in non-plumbed-in eyewash units, are dealt with in a guideline published by BG Chemie. Amendments This standard differs from DIN 12930:1995-12 as follows: a) Terms and definitions for eyewash units have been specifi
7、ed. b) The scope has been modified to eyewash units that are filled by the manufacturer. c) Requirements for the quality of the rinsing fluids have been included. d) Requirements for marking and information for use have been extended and brought in line with current law. Previous editions DIN 12930:
8、 1995-12 National Annex NA (informative) Bibliography TRGS 526, Technische Regel Gefahrstoffe 526 “Laboratorien” (obtainable via www.baua.de) BGI/GUV-I 850-0, Sicheres Arbeiten in Laboratorien Grundlagen und Handlungshilfen (obtainable via www.bgchemie.de) Guideline Anforderungen an Splflssigkeiten
9、zur Ersten Hilfe (obtainable via www.bgchemie.de) EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE 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 deauSicherheitsnotd
10、uschen - Teil 4: Augenduschen ohneWasseranschlussThis European Standard was approved by 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 alte
11、ration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 trans
12、lationunder the responsibility of a CEN member into its own language and notified to the 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, G
13、reece, 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 NORMUNGManagement
14、 Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15154-4:2009: EEN 15154-4:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions
15、.5 4 Performance requirements .6 4.1 Efficacy .6 4.2 Quality of rinsing fluid .6 4.3 Flow .6 4.4 Container for rinsing fluid .7 5 Functional Requirements 7 5.1 General 7 5.2 Single use eyewash units .7 5.3 Multiple use eyewash units 7 5.4 Reconditionable eyewash units .8 6 Information for use 8 6.1
16、Labelling and marking .8 6.2 Further information and instructions for use to be supplied 8 Bibliography . 10 DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 3 Foreword This document (EN 15154-4:2009) has been prepared by Technical Committee CEN/TC 332 “Laboratory equipment”, the secretariat of which is h
17、eld by DIN. This European Standard shall be given the status of a national 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 September 2009. Attention is drawn to the possibi
18、lity 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 identifying any or all such patent rights. EN 15154 consists of the following parts, under the general title Emergency safety showers Part 1: Plumbed-in body show
19、ers for laboratories Part 2: Plumbed-in eye wash units Part 3: Non plumbed-in body showers Part 4: Non plumbed-in eyewash 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 follo
20、wing countries are bound to implement this European Standard: 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, Slov
21、enia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 4 Introduction The first seconds after an accident in which the eyes have been exposed to harmful substances are critical to keep the eye injury to a minimum. Non plumbed-in emergency safety eyewash u
22、nits are designed and intended to be kept in the immediate proximity of persons working in a potentially hazardous area. The main 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 ca
23、re. DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 5 1 Scope This European Standard is a product specification, giving minimum performance requirements for non plumbed-in emergency safety eyewash units. It is applicable to non plumbed-in emergency safety eyewash units filled with a rinsing fluid by the
24、manufacturer for first aid use when the eyes have been exposed to harmful substances. Requirements are also given concerning labelling, marking and information to be supplied by the manufacturer. Throughout this standard, the term “non plumbed-in emergency safety eyewash unit” is referred to as “eye
25、wash unit“. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556-1, Ster
26、ilization of medical devices Requirements for medical devices to be designated “STERILE“ Part 1: Requirements for terminally sterilized medical devices EN 556-2, Sterilization of medical devices Requirements for medical devices to be designated “STERILE“ Part 2: Requirements for aseptically processe
27、d medical devices EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 non plumbed-in eyewash unit self contained devi
28、ce specially designed and intended to deliver a flushing fluid to irrigate and flush the eye(s) when exposed to harmful substances 3.2 transportable eyewash unit non plumbed-in eyewash unit that is a movable device 3.3 portable eyewash unit non plumbed-in eyewash unit that is designed to be carried
29、by a single person unaided and kept or mounted in immediate proximity of the user to supply immediate flushing 3.4 personal eyewash unit non plumbed-in eyewash unit that is designed to be carried by and on the user, in a pocket or a holster 3.5 single use eyewash unit non plumbed-in eyewash unit des
30、igned to deliver a single application of rinsing fluid DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 6 3.6 multiple use disposable eyewash unit non plumbed-in eyewash unit designed to deliver multiple applications of rinsing fluid prior to disposal EXAMPLE Pressurised spray-cans. 3.7 reconditionable ey
31、ewash unit non plumbed-in eyewash unit designed to be reconditioned 3.8 effective volume minimum volume of fluid that can be dispensed from the unit during intended operation 4 Performance requirements 4.1 Efficacy The efficacy of the product shall be sufficient to reduce the effects of harmful subs
32、tances. 4.2 Quality of rinsing fluid 4.2.1 General The 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 solutions. 4.2.2 Water If water is used in eyewash units, it shall be potable water or water of a similar qua
33、lity, wherein germ multiplication is prevented. NOTE Potable water is defined in the European Directive 98/83/EC. 4.2.3 Solutions If saline solutions, buffered solutions or other solutions are used in eyewash units, the solutions shall be sterile according to EN 556-1 or EN 556-2. NOTE Attention is
34、drawn to European Directives MDD 93/42/EEC and Medicine products 2001/83/EC. 4.3 Flow The flow pattern shall ensure rinsing of the entire area of the eye(s) including the eyelids. The design of eyewash units shall ensure that the pressure of the fluid at the point of delivery is minimised so as not
35、to cause injury to the eye. The design of the device shall allow for continuous flow of the rinsing fluid. DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 7 4.4 Container for rinsing fluid 4.4.1 General Eyewash units shall be designed in such a way as to be non hazardous to the user. Materials used in th
36、e construction of eyewash units shall not affect the quality of 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 apply for certain pressurised units. NOTE 2 The number of eyewash units positioned
37、in any work place location can be determined by the risk assessment for that location. 4.4.2 Transportable eyewash units Transportable eyewash units with a mass between 2 kg and 15 kg shall have handles or shall be able to be moved with a transport tool intended for this. With a mass greater than 15
38、 kg, they shall be fitted with wheels if they are intended to be moved by a single person. 4.4.3 Portable eyewash units Portable eyewash units shall have a mass less than 2 kg. They shall be designed to allow the user to firmly grip the unit with one hand. The minimum effective volume shall be 400 m
39、l for water. Portable eyewash units containing other solutions shall have an effective volume to achieve at least equivalent efficacy. 4.4.4 Personal eyewash units The effective volume of personal eyewash units shall be sufficient to provide immediate flushing while further fluid is obtained. The mi
40、nimum 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 a pocket or a holster without hindering movement during
41、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, even with closed eyes. Once activated, it shall be possible to operate the device with one hand. 5.2 Single use eyewash units Single use eyewash units
42、 shall be fitted with a tamper-evident device. 5.3 Multiple use eyewash units The device shall be designed so that it can be checked that it is fit and ready for use. DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 8 Products which are to be used on different casualties shall be designed to prevent cross
43、 contamination or infection. Multiple use eyewash units shall be fitted with a tamper-evident device. 5.4 Reconditionable eyewash units The device shall be designed to be reconditioned only by the manufacturer or authorized service agents. The design shall allow the device to be checked to ensure th
44、at it is fit and ready for use. The unit shall be fitted with a tamper-evident device. It shall be possible to mark/remark reconditioned eyewash units with the reconditioning date and the expiry date. Every reconditioning process shall be designed to prevent cross contamination or infection. 6 Infor
45、mation for use 6.1 Labelling and marking Eyewash 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) the details strictly
46、 necessary 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 by the word/symbol LOT, where appropriate, e) the symbol of hour glass expired date expressed as YYYY/MM, f) the sy
47、mbol 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) any warnings and/or precautions to take, including contraindications, j) intended purpose of the product, k) the effective volume, l) t
48、he wording “Reconditioning only by the manufacturer or authorized service agents.”, where appropriate. 6.2 Further information and instructions for use to be supplied Where information required to use the product safely can not be included on the product label, this information shall be provided sep
49、arately. DIN EN 15154-4:2009-07 EN 15154-4:2009 (E) 9 This information shall include: a) all the items listed in 6.1 with the exception of expiry date and batch code, b) a clear procedure for use of the product to reduce harmful substances and further procedures to obtain a harmless level, c) any chemical groups or specific chemicals that the unit is designed to decontaminate, if applicable, d) advice about placing the unit on a clearly visible and/or accessible location, within easy reach and in the immediate proximity of the risk source, e) in
