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Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BRITISH STANDARD Sterile urethral catheters for single use The European Standard EN 1616:1997, including its amendment A1:1999, has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW | BS EN | | | 1616 : 1997 | | | | Incorporating | Amendment No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BS EN 1616 : 1997 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/1, Catheters, upon which the following bodies were represented: Association of British Health-care Industries Association of Continence Advisors British Association of Urological Surgeons British Rubber Manufacturers' Association Ltd Medical Sterile Products Association This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1997 BSI 08-1999 The following BSI references relate to the work on this standard: Committee reference CH/1 Draft for comment 94/506464 DC ISBN 580 27652 X Amendments issued since publication Amd No Date Comments 10574 August 1999 Indicated by a sideline BS EN 1616 : 1997 Contents Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page Committees responsible Inside front cover National foreword ii Foreword Scope Normative references 3 Definitions Requirements Symbols and labelling Annexes A (normative) Test method for determining the strength of the catheter B (normative) Test method for determining the security of fit of the drainage funnel C (normative) Test method for determining balloon security 10 D (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation 11 E (informative) Bibliography 11 Tables Shaft dimensions Average flow rates C.1 Requirements for load test 10 D.1 Balloon test capacities 11 D.2 Balloon test volume percentage recovery 11 Figures Typical urethral catheters a) without and b) with balloon A.1 Apparatus and general arrangement for testing catheters' strength B.1 Test connector and general arrangement for testing security of fit of the drainage funnel BSI 08-1999 i BS EN 1616 : 1997 National foreword Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard has been prepared by Technical Committee CH/1 and is the English language version of EN 1616 : 1997 Sterile urethral catheters for single use, published by the European Committee for Standardization (CEN) It supersedes BS 1695 : Part : 1990 and Part : 1990, which are withdrawn Cross-references Publication referred to Corresponding British Standard EN 556 : 1994 BS EN 556 : 1995 Sterilization of medical devices Ð Requirements for terminally-sterilized devices to be labelled `Sterile' BS EN 980 : 1997 Graphical symbols for use in the labelling of medical devices BS EN 1618 : 1997 Catheters other than intravascular catheters Ð Test methods for common properties BS EN 20594-1 : 1994 Conical fittings with a % (Luer) taper for syringes, needles and certain other medical equipment Ð Part 1: General requirements EN 980 : 1996 EN 1618 : 1997 EN 20594-1 : 1993 The Technical Committee has reviewed the provisions of prEN 1041, to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this British Standard A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application Compliance with a British Standard does not of itself confer immunity from legal obligations Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages to 12, an inside back cover and a back cover The BSI copyright notice displayed throughout this document indicates when the document was last issued Sidelining in this document indicates the most recent changes by amendment ii BSI 08-1999 EN 1616 : 1997 EUROPEAN STANDARD NORME EUROPEÂENNE March 1999 + A1 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPAÈISCHE NORM December 1998 ICS 11.040.20 Descriptors: medical equipment, disposable equipment, urinary tract catheters, specifications, dimensions, flow rates, tensile strength, junctions, safety, labelling English version Sterile urethral catheters for single use (includes amendment A1:1999) Sondes urinaires steÂriles non reÂutilisables (inclut l'amendement A1:1999) Sterile Harnblasenkatheter zur einmaligen Verwendung (enthaÈlt AÈnderung A1:1999) This amendment A1 modifies the European Standard EN 1616 : 1997; it was approved by CEN on 13 February 1999 CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amenment into the relevant national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member This amendment 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 Central Secretariat has the same status as the official versions CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ CEN European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 1616 : 1997/A1 : 1999 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 Foreword Foreword to EN 1616 : 1997/A1 : 1999 This European Standard has been prepared by Technical Committee CEN/TC 205, Non-active medical devices, 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 August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997 According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom Annexes A, B, C and D form normative parts of this European Standard Annex E is for information This Amendment EN 1616 : 1997/A1 : 1999 to EN 1616 : 1997 has been prepared by Technical Committee CEN TC 205, Non-active medical devices, the Secretariat of which is held by BSI This Amendment to the European Standard EN 1616 : 1997 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 1999, and conflicting national standards shall be withdrawn at the latest by September 1999 According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom | || || || || || || || || | ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 Scope This European Standard specifies requirements for sterile, single-use urethral catheters, with and without balloons 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 EN 556 EN 980 prEN 1041 EN 1618 : 1997 EN 20594-1 Sterilization of medical devices Ð Requirements for medical devices to be labelled `Sterile' Information supplied by the manufacturer for medical devices Ð Graphical symbols for medical devices Terminology, symbols and information provided with medical devices Ð Information provided with medical devices supplied by the manufacturer Catheters other than intravascular catheters Ð Test methods for common properties Conical fittings with a % (Luer) taper for syringes, needles and certain other medical equipment Ð Part 1: General requirements (ISO 594-1 : 1986) 3.2 balloon capacity Volume of liquid to be introduced into the catheter in order to fill the inflation channel and inflate the balloon 3.3 shaft Portion of the catheter excluding the tip, balloon(s), funnel(s) and/or sideport 3.4 outside diameter Maximum dimension measured across the cylindrical portion of the shaft Requirements 4.1 General All tests shall be carried out on the product in the ready-for-use state 4.2 Surface finish When the catheter is ready for use (e.g treated according to the manufacturer's instructions) and is examined by normal or corrected-to-normal vision at 2,5 times magnification, the surface of the shaft, tip, balloon and eyes shall appear free from extraneous matter ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Definitions For the purposes of this European standard, the following definitions apply BSI 08-1999 3.1 urethral catheter Tubular device intended for being introduced into the vesical cavity through the urethra in order to provide drainage and/or flushing of the bladder 4.3 Dimensions 4.3.1 Size designation The size of the catheter shall be designated by its nominal outside diameter expressed in mm to the nearest 0,1 mm Tolerances on this stated size shall be ± 0,33 mm The balloon capacity shall be expressed in ml NOTE Additional units can also be given 4.3.2 Lengths The minimum overall length (L) and shaft lengths (S) shall be as given in table (see also figure 1) Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Drainage funnel Inflation funnel Valve Irrigation funnel L is the overall length S is the effective length Figure Typical urethral catheters a) without and b) with balloon BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 Table Shaft dimensions Catheter type L (minimum) mm S (minimum) mm Paediatric without balloon Paediatric with balloon Female without balloon Female with balloon Male without balloon Male with balloon 150 n.a.1) 220 150 150 n.a 220 360 130 n.a 360 275 1) 4.6.2 When tested by the method given in annex D, the percentage of water recovered shall be not lower than the value given in table D.2 4.7 Kinkability NOTE This subclause will be prepared when a test method has been developed 4.8 Flow rates When tested in accordance with the method given in annex E of EN 1618 : 1997, the minimum flow rates shall be as given in table 4.9 Biocompatibility The device shall be evaluated for biocompatibility and shall be free from biological hazard NOTE Methods for evaluation for biocompatibility are given in EN 30993 n.a = not applicable 4.4 Strength When tested in accordance with the method given in annex A, neither the tip nor the funnel shall become detached from the shaft, and the shaft shall not show any sign of breaking 4.5 Connector security When tested in accordance with the method given in annex B, the drainage funnel shall not part from the test connector 4.6 Balloon security 4.6.1 When tested in accordance with the method given in annex C, the balloon shall not leak and shall not occlude the drainage eyes 4.10 Sterility The device shall comply with EN 556 4.11 Corrosion test When tested in accordance with the method given in annex A of EN 1618 : 1997, the test specimen shall not show any evidence of corrosion ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ NOTE The change in profile at each end of the uninflated balloon should be smoothly blended with the shaft The balloon should be capable of approximately symmetrical expansion when filled with water at ambient temperature to its specified balloon capacity Symbols and labelling The symbols and information provided with catheters shall be as specified in EN 980 and prEN 1041, and in addition the following information shall be given: a) the manufacturer's stated minimum and maximum balloon inflation volumes; b) the designated size as given in 4.3.1 Table Average flow rates Designated size Average flow rate (minimum) equivalent1) Outside diameter CharrieÁre Drainage lumen Irrigation lumen mm FG/Ch/Fr ml/min ml/min 2,0 2,7 3,3 4,0 4,7 5,3 6,0 6,7 7,3 8,0 8,7 9,3 10,0 10 12 14 16 18 20 22 24 26 28 30 10 15 30 50 70 100 100 100 100 100 100 100 100 n.a.2) n.a n.a n.a 25 25 25 25 30 30 30 n.a n.a 1) 2) The CharrieÁre equivalent is given for information n.a = not applicable BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 | Annex A (normative) Test method for determining the strength of the catheter A.1 Principle Catheters fitted with balloons may be in situ for prolonged periods Such catheters are therefore immersed for 14 days in simulated urine prior to testing This step is omitted for catheters without balloons A tensile force is applied to the union of the tip and shaft of the catheter For catheters with lateral eyes, the tensile force is to be applied to the eyes For catheters with no lateral eyes, the tensile force is applied between the shaft of the catheter and the drainage funnel On removal of this force, the catheter is examined for signs of failure A.3 Apparatus A.3.1 Device for suspending catheter with lateral eyes, comprising a pin which passes through a drainage eye of the catheter, the pin having a diameter of between 50 % and 75 % of that of the drainage lumen of the catheter to be tested An example of a suitable device is shown in figure A.1a) For catheter without lateral eyes, the shaft of the catheter is suspended in a suitable clamp A.3.2 Device for attaching a weight to the drainage funnel and a weight, their combined mass being kg for catheters of outside diameter greater than 3,3 mm and 0,75 kg for catheters up to gauge size 3,3 mm A.3.3 Water bath or other device, capable of being controlled at (37 ± 2) ÊC A.2 Reagents A.3.4 Stopwatch A.2.1 Simulated urine, pH approximately 6,6, of the following composition, the reagents being of recognized analytical grade: A.4 Procedure Immerse the catheter in the freshly prepared simulated urine (A.2.1) in the water bath (A.3.3), controlled at (37 ± 2) ÊC, so that the balloon and shaft are completely submerged Allow the catheter to remain in the simulated urine for 14 days and then remove the catheter, rinse it with tap water and dry it Allow the catheter to come to a temperature of (23 ± 2) ÊC Suspend the catheter from the suspension device (A.3.1) by passing the pin into the drainage eye nearest the tip of the catheter (see figure A.1) For catheters without lateral eyes, use a suitable clamp Manually support the weight (A.3.2) Attach the weight to the drainage funnel of the catheter Gently lower the weight until it is freely suspended from the catheter Allow it to remain in this position for Remove the weight and visually examine all unions of the catheter for detachment or failure of bonds and any eyes for signs of splitting Urea 25,0 g Sodium chloride 9,0 g Disodium hydrogen orthophosphate, anhydrous 2,5 g Ammonium chloride 3,0 g Potassium dihydrogen orthophosphate 2,5 g Creatinine 2,0 g Sodium sulfite, hydrated 3,0 g Distilled water to 1,0 l WARNING This solution can support microbial growth There is a strong possibility that large numbers of microorganisms will be present in the solution at the end of the tests described in A.3 and C.3 These procedures should be carried out by trained personnel taking appropriate precautions in the handling of the immersed catheter and the disposal of the contaminated solution ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ A.5 Test report The test report shall contain the following information: a) the identity of the catheter; b) the condition of the tip/shaft union and eyes after testing BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 NOTE Dimension D is between 50 % and 75 % of the diameter of the catheter lumen a) Example of support frame and pin NOTE Dimension P is sufficient to allow the tip of the pin to engage the tip of the catheter and not permit the supporting member to engage the rim of the eye when the catheter is loaded b) Pin introduced through eye of catheter Inflation funnel Drainage funnel Valve Direction of test force c) Arrangement for testing Figure A.1 Apparatus and general arrangement for testing catheters' strength BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 Annex B (normative) Test method for determining the security of fit of the drainage funnel B.1 Principle A specified test connector is fitted to the drainage funnel of the catheter, and an axial extensional force is applied to test the security of the connection B.2 Apparatus B.2.1 Test connector, of rigid material, having the dimensions shown in figure B.1a) B.2.2 Clamp or similar device, for suspending the catheter B.2.3 Device for attaching a weight to the test connector and a weight, the combined mass of connector, device and weight being 0,75 kg for testing catheters up to size 3,3 mm and kg for testing all other outside diameters B.2.4 Stopwatch B.3 Procedure Carry out the test at (23 ± 2) ÊC Ensure that the drainage funnel of the catheter and the test connector (B.2.1) are clean and dry Fit the test connector into the drainage funnel to a depth of engagement of, or exceeding, 10 mm (i.e up to, or beyond, the mark on the connector) Suspend the catheter by clamping (B.2.2) it at a point near the junction of the funnels and the shaft (see figure B.1b)) Manually support the weight (B.2.3) Attach the weight to the test connector and gently lower the weight until it is freely suspended from the connector Allow it to remain in this position for and observe Record whether the test connector parts from the drainage funnel B.4 Test report The test report shall contain the following information: a) the identity of the catheter; b) whether the test connector remained in the funnel during the test BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page EN 1616 : 1997 Dimensions in millimetres a) Test connector Circumscribed mark Nominal taper 20 % (1 : 5) Clamp to suspend catheter Irrigation funnel Drainage funnel Inflation funnel Valve Test connector Direction of test force b) General arrangement for testing Figure B.1 Test connector and general arrangement for testing security of fit of the drainage funnel BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 10 EN 1616 : 1997 Annex C (normative) Test method for determining balloon security C.1 Principle The catheter balloon is inflated with water to the manufacturer's maximum stated capacity and immersed for 14 days in simulated urine A tensile force is applied to the catheter and the catheter examined visually for occlusion of the drainage eyes, if present, by the balloon and leakage from the balloon C.2 Reagents C.2.1 Distilled water C.2.2 Simulated urine, of composition given in A.2.1 C.3 Apparatus C.3.1 Device for suspending the catheter, consisting of a plate of rigid material, having the following constructional features a) A hole of diameter of mm greater than that of the nominal size of the catheter under test, with a countersink on the upper surface of the plate b) A countersink of 90Ê included angle of sufficient size to support the base of the balloon of the catheter under test c) No sharp edges at the junction of the hole and the countersink NOTE To facilitate placement of the catheter under test, the plate can comprise two halves, symmetrical about the centre line of the hole C.3.2 Water bath, or other device capable of being controlled at (37 ± 2) ÊC C.3.3 Device for attaching a weight to the drainage funnel or shaft of the catheter, and a series of weights, the combined masses of the attachment device and each weight being as given in table C.1 C.3.4 Stopwatch Table C.1 Requirements for load test Designated size Mass equivalent1) Outside diameter CharrieÁre mm FG/Ch/Fr kg 2,7 or less 3,3 4,0 4,7 5,3 to 10,0 or less 10 12 14 16 to 30 0,3 0,45 0,6 0,7 1,0 1) The CharrieÁre equivalent is given for information C.4 Procedure Inflate the catheter balloon with distilled water to manufacturer's maximum stated balloon capacity Immerse the catheter in the freshly prepared simulated urine (C.2.2) in the water bath (C.3.2) controlled at (37 ± 2) ÊC, so that the tip and the balloon are completely submerged Allow the catheter to remain in the simulated urine for 14 days, then remove the catheter, rinse it with tap water, and dry it Allow the catheter and contents to come to a temperature of (23 ± 2) ÊC Place the catheter in the suspension device (C.3.1), with the tip uppermost, the balloon resting in the countersink and the shaft protruding from the hole NOTE To facilitate placement of the catheter in a single piece suspension device, it may be necessary either to remove the funnels, having first ligatured the catheter shaft, or to drain the balloon, introduce the catheter and then reinflate the balloon Select the weight (C.3.3) appropriate to the catheter under test, as given in table C.1 Manually support the weight Attach the weight to the shaft or drainage funnel of the catheter and gently lower the weight until it is freely suspended from the catheter Allow it to remain in this position for With the weight in position, visually examine the catheter at the end of a period for: a) occlusion of the drainage eyes, if present, by the balloon b) leakage of water from the balloon C.5 Test report The test report shall contain the following information: a) the identity of the catheter; b) whether the drainage eyes were occluded by the balloon; c) whether leakage from the balloon was observed BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 11 EN 1616 : 1997 Annex D (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation Table D.1 Balloon test capacities D.1 Principle The catheter balloon and inflation lumen are inflated with water and immersed in simulated urine for 14 days The balloon is allowed to drain under gravity, and the volume of liquid recovered is measured D.2 Apparatus and reagents Table D.2 Balloon test volume percentage recovery D.2.1 Clamp or similar device, for suspending the catheter by the tip D.2.2 Male % (Luer) conical fitting, complying with EN 20594-1, e.g a Luer fitting syringe with the piston removed D.2.3 Water bath, or other device capable of being controlled at (37 ± 2) ÊC D.2.4 Measuring cylinder, with accuracy ± %, size appropriate to the balloon under test D.2.5 Distilled water D.2.6 Simulated urine, of composition given in A.2.1 D.3 Procedure Introduce into the catheter balloon, through the valve of the inflation funnel, the volume of distilled water (D.2.5) given in table D.1 Completely submerge the catheter in freshly prepared simulated urine (D.2.6) in the water bath (D.2.3), controlled at (37 ± 2) ÊC for 14 days Remove the catheter from the simulated urine, rinse it with tap water and dry it Insert the male Luer fitting (D.2.2) into the valve of the inflation funnel and allow the contents of the balloon to drain into a measuring cylinder until the flow of liquid stops, or for 15 min, whichever is the shorter period Allow the temperature of the liquid in the measuring cylinder (D.2.4) to come to 23 ± ÊC Measure the volume removed from the balloon and calculate the percentage recovered BSI 08-1999 Designated size Test capacity Outside diameter CharrieÁre equivalent1) mm FG/Ch/Fr 2,7 to 3,3 4,0 to 4,7 5,3 to 10,0 to 10 12 to 14 16 to 30 1) Nominal balloon capacity 1,2 balloon capacity 1,5 balloon capacity The CharrieÁre equivalent is given for information Balloon capacity Minimum percentage of test volume recovered ml % 10 20 30 55 75 80 80 D.4 Test report The test report shall contain the following information: a) the identity of the catheter, including the designated size and balloon capacity; b) the volume of liquid recovered through the valve, expressed as a percentage of the volume introduced Annex E (informative) Bibliography EN 30993 Biological evaluation of medical devices 12 blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1616 : 1997 List of references See national foreword BSI 08-1999 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1616 : 1997 BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð 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 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