Bsi bs en 15154 3 2009

BS EN 15154 3 2009 ICS 13 100; 71 040 10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Emergency safety showers Part 3 Non plumbed in body showers This Britis[.]

BS EN 15154-3:2009

ICS 13.100; 71.040.10

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BRITISH STANDARD

Emergency safety

showers

Part 3: Non plumbed-in body showers

This British Standard is the UK implementation of EN 15154-3:2009 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 15154-3:2009

EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN 15154-3

March 2009

ICS 71.040.10

English Version

Emergency safety showers - Part 3: Non plumbed-in body

showers

Douches de sécurité - Partie 3: Douches pour le corps non

raccordées au réseau d'eau Sicherheitsnotduschen - Teil 3: Körperduschen 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 washing 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 supplied 9

Bibliography 10

BS EN 15154-3:2009

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 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 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 immediate 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

BS EN 15154-3:2009

EN 15154-3:2009 (E)

5

1 Scope

This European 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 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 referred 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

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 body shower

self contained 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

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

single 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 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 General

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 European 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

BS EN 15154-3:2009

EN 15154-3:2009 (E)

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4.4 Container 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 the 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 water 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 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 have 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 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 single 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 use body showers shall be fitted with a tamper-evident device

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 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 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 for 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 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 the 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,

BS EN 15154-3:2009

EN 15154-3:2009 (E)

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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

This 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 procedures 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 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

[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] 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 15154-3:2009

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