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[.]

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 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.

BS EN 15154-4:2009

EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN 15154-4

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 ohneWasseranschluss

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

C O M IT É E U R O P É E N D E N O R M A LIS A T IO N 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

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 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 Labelling and marking 8

6.2 Further information and instructions for use to be supplied 8

Bibliography 10

BS EN 15154-4:2009

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 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

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)

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 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"

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, 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

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 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

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

4 Performance requirements

4.1 Efficacy

The efficacy of the product shall be sufficient to reduce the effects of harmful substances

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 quality, 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 drawn to European Directives MDD 93/42/EEC and Medicine products 2001/83/EC

4.3 Flow

BS EN 15154-4:2009

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 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 1 The European Directive PED 97/23/EC can apply for certain pressurised units

NOTE 2 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 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 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 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 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 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

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 Information 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 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 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,

BS EN 15154-4:2009

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) 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

[1] 98/83/EC, Council Directive 98/83/EC of 3 November 1998 relating to the quality of water intended for human consumption

[2] 93/42/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 6 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

BS EN 15154-4:2009

This page has been intentionally left blank

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 8996 7400

BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards

Buying standards

Orders for all BSI, international and foreign standards publications should be addressed to Customer Services Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996

7001 Email: orders@bsigroup.com You may also buy directly using a debit/credit card from the BSI Shop on the Website http://www.bsigroup.com/shop

In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British Standards, unless otherwise requested

Information on standards

BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service Various BSI electronic information services are also available which give details on all its products and services Contact Information Centre Tel: +44 (0)20 8996 7111 Fax: +44 (0)20 8996 7048 Email: info@bsigroup.com Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards For details

of these and other benefits contact Membership Administration Tel: +44 (0)20

8996 7002 Fax: +44 (0)20 8996 7001 Email: membership@bsigroup.com Information regarding online access to British Standards via British Standards Online can be found at http://www.bsigroup.com/BSOL

Further information about BSI is available on the BSI website at http://

www.bsigroup.com

Copyright