Bsi bs en 15154 4 2009

BS EN 15154 4 2009 ICS 13 100; 71 040 10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Emergency safety showers Part 4 Non plumbed in eyewash units This Briti[.]

BRITISH STANDARD Emergency safety showers Part 4: Non plumbed-in eyewash units ICS 13.100; 71.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 15154-4:2009 BS EN 15154-4:2009 National foreword This British Standard is the UK implementation of EN 15154-4:2009 The UK participation in its preparation was entrusted to Technical Committee LBI/18, Laboratory furniture and fittings A list of organizations represented on this committee can be obtained on request to its secretary 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 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2009 © BSI 2009 ISBN 978 580 58848 Amendments/corrigenda issued since publication Date Comments BS EN 15154-4:2009 EN 15154-4 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM March 2009 ICS 71.040.10 English Version Emergency safety showers - Part 4: Non plumbed-in eyewash units Douches de sécurité - Partie 4: Unités de lavage d'yeux non raccordées au réseau d'eau Sicherheitsnotduschen - Teil 4: Augenduschen ohne Wasseranschluss This 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 European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national 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 translation under the responsibility of a CEN member into its own language and notified 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, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 15154-4:2009: E BS EN 15154-4:2009 EN 15154-4:2009 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions 4.1 4.2 4.3 4.4 Performance requirements Efficacy Quality of rinsing fluid Flow Container for rinsing fluid 5.1 5.2 5.3 5.4 Functional Requirements General Single use eyewash units .7 Multiple use eyewash units Reconditionable eyewash units 6.1 6.2 Information for use Labelling and marking Further information and instructions for use to be supplied Bibliography 10 BS EN 15154-4:2009 EN 15154-4:2009 (E) Foreword This document (EN 15154-4:2009) 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 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 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 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 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 following 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, Slovenia, Spain, Sweden, Switzerland and the United Kingdom BS EN 15154-4:2009 EN 15154-4:2009 (E) 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 units 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 care BS EN 15154-4:2009 EN 15154-4:2009 (E) 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 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 "eyewash unit" 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, 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 aseptically processed medical devices EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices Terms and definitions For the purposes of this document, the following terms and definitions apply 3.1 non 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 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 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 designed to deliver a single application of rinsing fluid BS EN 15154-4:2009 EN 15154-4:2009 (E) 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 eyewash 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 Performance requirements 4.1 Efficacy The efficacy of the product shall be sufficient to reduce the effects of harmful substances 4.2 4.2.1 Quality of rinsing fluid 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 quality, wherein germ multiplication is prevented NOTE 4.2.3 Potable water is defined in the European Directive 98/83/EC 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 4.3 Attention is drawn to European Directives MDD 93/42/EEC and Medicine products 2001/83/EC 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 to cause injury to the eye The design of the device shall allow for continuous flow of the rinsing fluid BS EN 15154-4:2009 EN 15154-4:2009 (E) 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 the 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 The European Directive PED 97/23/EC can apply for certain pressurised units NOTE The number of eyewash units positioned 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 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 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 kg They shall be designed to allow the user to firmly grip the unit with one hand The minimum effective volume shall be 400 ml 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 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 a pocket or a holster without hindering movement during work 5.1 Functional Requirements General Eyewash units shall be able to be activated for immediate use by a single person within a maximum of 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 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 BS EN 15154-4:2009 EN 15154-4:2009 (E) Products which are to be used on different casualties shall be designed to prevent cross 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 that 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 6.1 Information for use 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 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 f) the symbol expired date expressed as YYYY/MM, 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) 6.2 the wording “Reconditioning only by the manufacturer or authorized service agents.”, where appropriate 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 BS EN 15154-4:2009 EN 15154-4:2009 (E) 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) information on installation and maintenance, if applicable, f) contact information regarding the reconditioning of the device, if applicable, g) explanation of the symbols used in accordance with EN 980 BS EN 15154-4:2009 EN 15154-4:2009 (E) Bibliography [1] 98/83/EC, Council Directive 98/83/EC of November 1998 relating to the quality of water intended for human consumption [2] 93/42/EEC, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [3] 2001/83/EC of the European Parliament and of the Council of November 2001 on the Community code relating to medicinal products for human use [4] 97/23/EC, Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment 10 BS EN 15154-4:2009 This page has been intentionally left blank BS EN 15154-4:2009 BSI - British Standards Institution BSI is the independent national body responsible for preparing British Standards It presents the UK view on standards in Europe and at the international level It is incorporated by Royal Charter Revisions British Standards are updated by amendment or revision Users of British Standards should make sure that they possess the latest amendments or editions It is the constant aim of BSI to improve the quality of our products and services We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover Tel: +44 (0)20 8996 9000 Fax: +44 (0)20 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