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!$XV0“1535113www.
2、din.deDDIN EN 15154-3Emergency safety showers Part 3: Non plumbed-in body showersEnglish version of DIN EN 15154-3:2009-07Sicherheitsnotduschen Teil 3: Krperduschen ohne WasseranschlussEnglische Fassung DIN EN 15154-3:2009-07www.beuth.deDocument comprises pages12DIN EN 15154-3:2009-07 Start of valid
3、ity 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 CEN/TC 332 “Laboratory equipment” (Sec
4、retariat: 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 Committee NA 055-02-03 AA Laborarmaturen. This Euro
5、pean 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 rules TRGS 526 and BGI/GUV-I 850-0 (see National Anne
6、x NA below). 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) 2 EUROPEAN STANDARD NORME EUROPENNE EUR
7、OPISCHE NORM EN 15154-3 March 2009 ICS 71.040.10 English Version Emergency safety showers Part 3: Non plumbed-in body showers Douches de scurit Partie 3: Douches pour le corps non raccordes au rseau deau Sicherheitsnotduschen Teil 3: Krperduschen ohne Wasseranschluss This European Standard was appro
8、ved 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationa
9、l standards 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 noti
10、fied to the CEN Management Centre has the same status as the official 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, Mal
11、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of expl
12、oitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15154-3:2009: EEN 15154-3:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Performance requirements .6 4.1 Efficacy .6 4.2 Quality of wash
13、ing fluid 6 4.3 Flow .6 4.4 Container for washing fluid 7 5 Functional Requirements 7 5.1 General 7 5.2 Single use body showers 7 5.3 Multiple use body showers .8 5.4 Refillable body showers 8 6 Information for use 8 6.1 Labelling and marking .8 6.2 Further information and instructions for use to be
14、 supplied 9 Bibliography . 10 DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 3 Foreword This document (EN 15154-3:2009) has been prepared by Technical Committee CEN/TC 332 “Laboratory equipment”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national stan
15、dard, 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 possibility that some of the elements of this document may be the subject of patent ri
16、ghts. 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 showers for laboratories Part 2: Plumbed-in eye wash units Part 3: Non plumbed-in b
17、ody 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 following countries are bound to implement this European Standard: Austria, Belgium,
18、 Bulgaria, Cyprus, Czech Republic, Denmark, 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 United Kingdom. DIN EN 15154-3:2009-07
19、 EN 15154-3:2009 (E) 4 Introduction The first seconds after an accident in which the body or parts of the body have been exposed to harmful substances or heat are critical to keep the injury to a minimum. Non plumbed-in emergency safety body showers are designed and intended to be kept in the immedi
20、ate proximity of persons working in a potentially hazardous area. The main purpose of these devices is to supply immediate first aid. Non plumbed-in emergency safety body showers can also allow continued washing on the way to medical care. DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 5 1 Scope This Eu
21、ropean Standard is a product specification, giving minimum performance requirements for non plumbed-in emergency safety body showers. 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 service. Both variations are
22、for first aid use when the body or parts of the body have been exposed to harmful substances or heat. 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 body shower” is refe
23、rred to as “body shower”. 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.
24、EN 556-1, Sterilization 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 asepti
25、cally processed 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 body shower self c
26、ontained device specially designed to reduce the amount of harmful substances or heat by a cascading or spraying of washing fluid on the body or parts of the body 3.2 fixed body shower non plumbed-in body shower which is designed to be in a fixed and stationary position 3.3 transportable body shower
27、 non plumbed-in body shower that is a movable device 3.4 portable body shower non plumbed-in body shower that is designed to be carried by a single person unaided and kept or mounted in the immediate proximity of the user to supply immediate washing DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 6 3.5 s
28、ingle use body shower non plumbed-in body shower designed to deliver a single application of washing fluid 3.6 multiple use body shower non plumbed-in body shower designed to deliver multiple applications of washing fluid 3.7 refillable body shower non plumbed-in body shower designed to be refilled
29、after use 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 substances and/or heat. 4.2 Quality of washing fluid 4.2.1 Gen
30、eral The 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 solutions. 4.2.2 Water If water is used in body showers, it shall be potable water or water of a similar quality. NOTE Potable water is defined in the Euro
31、pean Directive 98/83/EC. 4.2.3 Solutions If saline solutions, buffered solutions or other solutions are used in body showers, the solutions shall be sterile according to EN 556-1 or EN 556-2. NOTE Attention is drawn to European Directive MDD 93/42/EEC. 4.3 Flow Body showers shall be designed to prov
32、ide 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 proper washing/heat reduction according to the manufacturers specified field of application. DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 7 4.4 C
33、ontainer for washing fluid 4.4.1 General Body showers shall be designed in such a way as to be non hazardous to the user. Materials used in the construction of body showers shall not affect the quality of the fluid nor shall the fluid affect the materials of the container during the shelf life of th
34、e product. The effective volume of body showers shall be sufficient to provide immediate washing while further fluid is obtained, if necessary. NOTE The European Directive PED 97/23/EC can apply for certain pressurised units. 4.4.2 Fixed body showers The minimum effective volume shall be 100 l for w
35、ater. Fixed body showers containing other solutions shall have an effective volume to achieve at least equivalent efficacy, which shall be proven by the manufacturer. 4.4.3 Transportable body showers Transportable body showers shall be fitted with wheels/rollers/others in order to be easily handled
36、and moved. If water is used, the minimum effective volume shall be 15 l. Transportable body showers containing other solutions shall have an effective volume to achieve at least equivalent efficacy, which shall be proven by the manufacturer. 4.4.4 Portable body showers Portable body showers shall ha
37、ve a mass of less than 15 kg. They shall be designed to allow the user to firmly grip the unit. If water is used, the minimum effective volume shall be 10 l. Portable body showers containing other solutions shall have an effective volume to achieve at least equivalent efficacy, which shall be proven
38、 by the manufacturer. Portable body showers specifically designed for heat reduction of thermal burns may have an effective volume of less than 10 l and shall be marked accordingly (see 6.1 j). 5 Functional Requirements 5.1 General Body showers shall be able to be activated for immediate use by a si
39、ngle 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, it shall be possible to temporarily deactivate it, to save washing fluid. 5.2 Single use body showers Single
40、 use body showers shall be fitted with a tamper-evident device. DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 8 5.3 Multiple use body showers The device shall be designed so that it can be checked that it is fit and ready for use. Products which are to be used on different casualties shall be designed
41、to prevent cross contamination or infection. 5.4 Refillable 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 tamper-evident device. It shall be possible to mark/remark refillable body showers with the
42、 filling date and the expiry date and to reset or replace the tamper-evident device. Every refilling/reconditioning process shall be designed to prevent cross contamination or infection and maintain the initial efficiency level. The unit shall be designed to enable thorough cleaning. 6 Information f
43、or use 6.1 Labelling and marking Body showers shall be labelled and marked in accordance with EN 1041 and EN 980. Body showers 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 necessary
44、 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 YYYY/MM (for refillable devices the expiry date for th
45、e content shall be stated 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) any warnings and/or precautions to take, including contraindications, j) the intended p
46、urpose of the product, k) the effective volume. DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 9 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 separately. T
47、his 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 harmful substances or cool thermal burns and further pr
48、ocedures 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 clearly visible and/or accessible location, within easy reach and in the immediate proximity
49、 of the risk source, f) information on installation and maintenance, 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, if assigned as transportable body shower, i) explanation of the symbols used in accordance with EN 980. DIN EN 15154-3:2009-07 EN 15154-3:2009 (E) 10 Bibliography 1 98/83/EC, Council Directive 98/83/EC of 3 November 1998 relating to the quality of water intended for human consumption 2 93
