Bsi bs en 13544 3 2001 + a1 2009

BRITISH STANDARD BS EN 13544 3 2001 +A1 2009 Respiratory therapy equipment — Part 3 Air entrainment devices ICS 11 040 10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Li ce n[.]

Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BRITISH STANDARD Respiratory therapy equipment — Part 3: Air entrainment devices ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 13544-3:2001 +A1:2009 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 National foreword This British Standard is the UK implementation of EN 13544-3:2001+A1:2009 It supersedes BS EN 13544-3:2001 which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by !" The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to CH/ 121/5, Lung ventilators, tracheal tubes and related equipment A list of organizations represented on this subcommittee 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, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 2001 © BSI 2010 ISBN 978 580 65094 Amendments/corrigenda issued since publication Date Comments 31 March 2010 Implementation of CEN amendment A1:2009 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 13544-3:2001+A1 NORME EUROPÉENNE EUROPÄISCHE NORM September 2009 ICS 11.040.10 Supersedes EN 13544-3:2001 English Version Respiratory therapy equipment - Part 3: Air entrainment devices Appareils de thérapie respiratoire - Partie 3: Dispositifs d'entrnement d'air Atemtherapiegeräte - Teil 3: Luftbeimischgeräte This European Standard was approved by CEN on April 2001 and includes Amendment approved by CEN on 30 July 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 13544-3:2001+A1:2009: E Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Contents Page Foreword  1 Scope  2 Normative references  3 3.1 Terms and definition 4 Air entrainment device 4 4 Oxygen supply  5 5.1 5.2 Connections  Oxygen supply inlet 4 Air inlet attachments 5 6 Delivered oxygen concentration  7 7.1 7.2 Marking and identification 5 Marking  Colour coding  8 Information supplied by the manufacturer 6 9 !Usability  10 Clinical evaluation  Annex A (normative) Method of test for delivered oxygen concentration  Annex B (informative) Rationale 12 Annex C (informative) Colour coding 13 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC" " 14 Bibliography 15  Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Foreword This document (EN 13544-3:2001+A1:2009) has been prepared by Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI 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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010 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 This document includes Amendment 1, approved by CEN on 2009-07-30 This document supersedes EN 13544-3:2001 The start and finish of text introduced or altered by amendment is indicated in the text by tags !" This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s) For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard This European Standard applies to respiratory therapy equipment and has been prepared in three parts This Part addresses air entrainment devices; part and part address respectively nebulizing systems and tubing and connectors Annex A is normative and forms part of this European Standard Annexes B, C and ZA are for information only 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 United Kingdom Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Scope This part of this European Standard specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients It gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration This standard does not cover air entrainment devices which are integral with medical devices specified in other standards e.g emergency lung ventilators, humidifiers, nebulizers, etc Normative references This European Standard incorporates by dated or undated reference, provisions from other publications These normative references are cited at the appropriate places in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision For undated references the latest edition of the publication referred to applies (including amendments) EN 738-1, Pressure regulators for use with medical gases – Part : Pressure regulators and pressure regulators with flow metering devices EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices prEN 13159, Compatibility of medical equipment with oxygen EN ISO 4135, Anaesthetics and respiratory equipment – Vocabulary Terms and definition For the purposes of this part of this European Standard, terms and definitions given in EN ISO 4135 and the following term and definition apply 3.1 Air entrainment device Device consisting of a jet orifice (to which the oxygen supply is connected) adjacent to a series of air entrainment ports, the distal end of the device being designed for connection to an oxygen delivery system supplying a patient NOTE These devices are sometimes described as Venturi devices This term has been avoided as very few actually use the venturi principle Oxygen supply The device shall be designed to operate with an oxygen supply controlled by a flowmeter control valve capable of delivering at least 15 l/min of oxygen and complying with EN 738-1 and prEN 13159 5.1 Connections Oxygen supply inlet The inlet for oxygen to the air entrainment device should be a nipple conforming to prEN 13544-2 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) 5.2 Air inlet attachments Any air inlet attachment provided with or recommended for use with the air entrainment device shall neither affect the safety nor the performance of the device nor cover any marking of the device The attachment shall not become detached when tested as described in A.2.8 (normative) Delivered oxygen concentration When tested as described in annex A, the delivered oxygen concentration shall be as given in Table Table - Delivered oxygen concentration Designated O2 concentration Delivered O2 concentration (%) (%) v/v max (%) v/v 24 23 25 28 27 29 31 30 32 35 33 37 40 38 42 50 47 53 60 56 64 Additional information is given in annex B Marking and identification EN 980 and EN 1041 apply with the following additions : 7.1 Marking 7.1.1 Each fixed concentration air entrainment device shall be marked with : a) the designated oxygen concentration in characters at least 2,5 mm high ; b) the recommended flow in l/min in characters at least 2,5 mm high 7.1.2 The immediate packaging of the device shall also carry the above information, together with the following : a) !the name or trade mark of the manufacturer and the name and address of the authorized representative where the manufacturer does not have a registered place of business in the European Community;" b) a lot or serial number or date of manufacture ; c) !if designed for single use only, the words “SINGLE USE” or the appropriate symbol For single use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request NOTE The manufacturer's attention is drawn to the regulatory provision for a consistent use of indication for single use devices " Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) 7.1.3 Air entrainment devices with a control to adjust the oxygen concentration shall conform to item b) of 7.1.1 and items a) to c) of 7.1.2 and in addition with either of the following : a) The minimum and maximum settings shall be marked with their respective oxygen concentrations (see d)) in characters at least 2,5 mm high, and the direction of movement of the control to increase the delivered oxygen concentration shall be indicated b) A scale of delivered oxygen concentration shall be provided, marking each of these designated concentrations listed in Table which is attainable by the adjustment of the control 7.2 Colour coding 7.2.1 If colour coding is used as an additional means of identification of the designated oxygen concentration on air entrainment devices, the colour code given in Table shall be used The colour codes shall be applied directly to the air entrainment device and shall have an area of at least cm2 The colour coding shall either be visible through the immediate external packaging or shall be repeated on the outside of the immediate external packaging Table - Colour coding Designated O2 concentration Colour % v/v (see annex C for references of colours given as examples) 24 Blue 28 White 31 Orange 35 Yellow 40 Red 50 Pink 60 Green 7.2.2 The colours of the code shall not be used for any purpose other than identifying the delivered oxygen concentration NOTE Air entrainment devices provided with a control to adjust the delivered oxygen concentration may use the colour code given in Table to identify the selected values Information supplied by the manufacturer With each package of devices, the manufacturer shall provide operating instructions and information complying with EN 1041 including : a) a table or graph showing the relationship between the oxygen supply flow and the resulting total flow of the delivered air/oxygen mixture ; b) the minimum, recommended and maximum flows of oxygen which enable the device to achieve the designed performance ; c) if the device is intended for re-use, details of suitable methods of cleaning, disinfecting and/or sterilization ; d) !for devices in accordance with 7.1.3, a warning that means of determining the patient oxygenation should be used (e.g pulse oximeter, oxygen monitor) The instructions for use shall contain the date of issue or the latest revision." ! Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) e) If phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient the medical device shall be labelled accordingly If such devices are used for the treatment of children or treatment of pregnant or nursing women, the residual risk has to be identified and stated in the instructions for use NOTE Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction." !Usability The manufacturer shall address in a usability engineering process the risk resulting from poor usability (see EN 60601-1-6 and EN 62366) Check compliance by inspection of the usability engineering file 10 Clinical evaluation A clinical evaluation shall be performed and documented in the risk management file Check compliance by inspection of the risk management file." Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Annex A (normative) Method of test for delivered oxygen concentration A.1 Apparatus A.1.1 Oxygen supply and flowmeter with control valve, the flowmeter to be capable of delivering and measuring flows between l/min and 30 l/min with an accuracy of ± 2,5 % A.1.2 Sampling T-piece, shown in Figure A.1 NOTE It is essential that the manufacturer designs the T-piece inlet to connect to the particular design of air entrainment device, and makes details of this T-piece available to test houses The side branch can be varied to suit the design of oxygen analyser, and it is essential that it provides a close fit to the oxygen sensor or analyser sampling tube in order to prevent leakage to or from the exterior NOTE The inclusion of corrugated breathing tubing between the outlet of an air entrainment device and the face mask has been found to modify the inspired oxygen concentration If an air entrainment device is intended to be used only with a particular delivery system, the manufacturer can perform these tests with the system attached, and shall record this fact in the test report(s) A.1.3 Oxygen analyser, capable of measuring the concentration of oxygen with an accuracy of ± 0,1 % oxygen within the zone shown in Figure A.1 A.1.4 Equipment capable of measuring barometric pressure, relative humidity and ambient temperature with an accuracy of ± % A.2 Procedure NOTE Good ventilation or scavenging of the mixture from the devices under test is necessary to prevent entrainment of air which has already been enriched by oxygen from previous experiments A.2.1 If the device is intended to be re-used, condition it prior to these tests by subjecting it to twenty cycles of cleaning and sterilization in accordance with manufacturer’s instructions A.2.2 Carry out the tests at conditions of (22 ± 2) °C, 101,3 kPa and (50 ± 5) % RH, or correct results to these conditions A.2.3 Assemble the device to be tested to the T-piece (A.1.2) ensuring that there are no visible gaps which might permit leakage of air or gas Connect the oxygen supply flowmeter (A.1.1) to the oxygen nipple with the tubing recommended by the manufacturer (see Figure A.2) A.2.4 Calibrate the oxygen analyser (A.1.3) according to the manufacturer’s instructions and connect or position it so as to take samples from the zone shown in Figure A.1 A.2.5 Adjust the oxygen supply flowmeter control to the minimum flow stated by the manufacturer of the air entrainment device, and record the oxygen analyser reading after approximately Correct the reading to 20 °C and 101,3 kPa (A.1.4) A.2.6 Repeat the test at the recommended flow and at the maximum flow stated by the manufacturer of the air entrainment device A.2.7 If the device is intended for use with an air inlet attachment, repeat the tests with the attachment fitted A.2.8 Test the security of the air inlet attachment by securing the attachment so that it is not distorted and applying an axial tensile force of (5 ± 0,5) N to the oxygen nipple of the air entrainment device for (60 ± 2) s Record whether the device separates from the air inlet attachment Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Repeat the test applying the axial force in the opposite direction, i.e compressing the device into the attachment Dimensions in millimetres 35 50 max 35 50 max ¯ 18 ¯ 24 max Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Key To fit device under test To suit oxygen analyser probe Sample oxygen concentration within 10 mm spherical zone indicated Figure A.1 – T-piece for oxygen output determination (see A.1.2) 10 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Key Device under test Oxygen supply Air ports not to be obstructed Air/oxygen outlet not to be obstructed (see note to A.1.2) To oxygen analyser Figure A.2 – Test rig of oxygen output determination (see A.2.3) 11 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Annex B (informative) Rationale This part of this European standard relates to air entrainment devices designed for providing respiratory therapy in which an air entrainment system is used to provide a pre-set mixture of oxygen and room air, thus supplying the patient with a controlled oxygen concentration above atmospheric level This type of therapy requires close control of the inhaled oxygen concentration, and the clinician may require to be able to make small but significant changes in this factor and then to ensure continuity over quite long periods Devices are therefore manufactured to produce a number of different concentrations each to relatively close limits Compliance with these tests does not ensure that the patient will necessarily receive the designated oxygen concentration, because physiological factors such as the patient’s ventilatory pattern, lung compliance and airway resistance, together with apparatus factors such as the volume of reservoirs, fit of the mask to the patient etc will influence the actual inspired oxygen concentration 12 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Annex C (informative) Colour coding References of colours, suitable for Table C.1, are given as examples as follows : Table C.1 – Examples of colour references Colour BS 381C reference number L a b Munsell Blue 166 43,34 1,79 -37,73 6,2PB 3,8 10,4 Orange 557 59,05 37,97 52,09 2,9YR 5,8 11,8 Yellow 309 80,71 3,14 80,03 5.9Y 8,1 11,6 Red 537 44,3 49,68 32,29 7,5R 4,2 13,4 Pink 447 70,79 20,10 22,05 2,1YR 6,9 5,7 Green 218 48,94 -21,72 27,04 8,3GY 4,6 6.1 13 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC" " !This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations." Table ZA.1 - Correspondence between this European Standard and EU Directives Clause/subclause of this European Standard Corresponding essential requirement of Directive 93/42/EEC 1, 2, 12.8.1 1, 2, 9.1, 12.7.4 1, 2, 3, 1, 2, 12.9, 13.3 7.1.1 13.1 7.1.2 13.1, 13.2, 13.3, 13.5 7.2 13.2 2, 13.1, 13.3, 13.6 8d) 13.6 h) !9 (2 dash) 10 6a 7.5 (1 paragraph) e) 7.5 (2 7.1.2 a) 13.3 (a): 7.1.2 c) 13.3 (f) 7.1.2 c) 13.6 (h) (2 13.6 (q)" nd paragraph, st dash & Comments nd st nd rd paragraph & paragraph) nd paragraph) !WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard." 14 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001+A1:2009 EN 13544-3:2001+A1:2009 (E) Bibliography [1] Oxygen therapy Physiological principles, monitoring and administration technique, Leigh J.M., Crit Care Intl., 1984, Vol 3, No 4, pp4-7 [2] Air entrainment masks: Jet mixing is how they work ; the Bernoulli and Venturi principles are how they don’t, Scarri R., Resp Care, 1979, Vol 24, No 10, pp 928-931 [3] BS 381C:1988 – Specifications for colours for identification, coding and special purposes [4] Munsell Book of Color1) prEN 13544-2, Respiratory therapy equipment – Part : Specifications for tubing and connectors !EN 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability EN 62366, Medical devices - Application of usability engineering to medical devices" 1) Available from Munsell Color, 2441 N Calvert Street, Baltimore, Maryland, 21218, USA 15 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/07/2010 07:32, Uncontrolled Copy, (c) BSI BS EN 13544-3:2001 +A1:2009 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 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 BSI Group Headquarters 389 Chiswick High Road, London, W4 4AL, UK Tel +44 (0)20 8996 9001 Fax +44 (0)20 8996 7001 www.bsigroup.com/ standards Copyright subsists in all BSI publications BSI also holds the copyright, in the UK, of the publications of the international standardization bodies Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior written permission from BSI This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained Details and advice can be obtained from the Copyright and Licensing Manager Tel: +44 (0)20 8996 7070 Email: copyright@bsigroup.com