1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1616 : 1997 Incorpo
2、rating Amendment No. 1 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 Sterile urethral catheters for single useBS EN 1616 : 1997 This British Standard, havi
3、ng 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/
4、506464 DC ISBN 0 580 27652 X Amendments issued since publication Amd. No. Date Comments 10574 August 1999 Indicated by a sideline Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/1, Catheters, upon which the following b
5、odies 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 AssociationBS EN 1616 : 1997 BSI 08-1999 i Contents Page Committees responsible I
6、nside front cover National foreword ii Foreword 2 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Requirements 3 5 Symbols and labelling 5 Annexes A (normative) Test method for determining the strength of the catheter 6 B (normative) Test method for determining the security of fit of the draina
7、ge funnel 8 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 1 Shaft dimensions 5 2 Average flow rates 5 C.1 Requirements for load test 10
8、 D.1 Balloon test capacities 11 D.2 Balloon test volume percentage recovery 11 Figures 1 Typical urethral catheters a) without and b) with balloon 4 A.1 Apparatus and general arrangement for testing catheters strength 7 B.1 Test connector and general arrangement for testing security of fit of the dr
9、ainage funnel 9ii BSI 08-1999 BS EN 1616 : 1997 National foreword 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 sup
10、ersedes BS 1695 : Part 1 : 1990 and Part 2 : 1990, which are withdrawn. Cross-references Publication referred to Corresponding British Standard EN 556 : 1994 BS EN 556 : 1995 Sterilization of medical devices Requirements for terminally-sterilized devices to be labelled Sterile EN 980 : 1996 BS EN 98
11、0 : 1997 Graphical symbols for use in the labelling of medical devices EN 1618 : 1997 BS EN 1618 : 1997 Catheters other than intravascular catheters Test methods for common properties EN 20594-1 : 1993 BS EN 20594-1 : 1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain ot
12、her medical equipment Part 1: General requirements 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
13、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 i
14、i, the EN title page, pages 2 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.CEN European Committee for Standardization C
15、omite Europe en de Normalisation Europa isches Komitee fu r 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 EUROPEAN STANDARD EN 1616 : 1
16、997 March 1999 +A 1 December 1998 NORME EUROPE ENNE EUROPA ISCHE NORM 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 sin
17、gle use (includes amendment A1:1999) Sondes urinaires ste riles non re utilisables (inclut lamendement A1:1999) Sterile Harnblasenkatheter zur einmaligen Verwendung (entha lt A nderung A1:1999) This amendment A1 modifies the European Standard EN 1616 : 1997; it was approved by CEN on 13 February 199
18、9. 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
19、 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
20、 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.Page 2 EN 1616 : 1997 BSI 08-1999 For
21、eword 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
22、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, Fr
23、ance, 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. | | | | | | | | | | | | | | | | | | Foreword to EN 1616 : 19
24、97/A1 : 1999 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, ei
25、ther 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 b
26、ound 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.Page 3 EN 1616 : 1997 BSI 08-1999 1 Scope This European Standar
27、d specifies requirements for sterile, single-use urethral catheters, with and without balloons. 2 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
28、 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
29、 556 Sterilization of medical devices Requirements for medical devices to be labelled Sterile EN 980 Information supplied by the manufacturer for medical devices Graphical symbols for medical devices prEN 1041 Terminology, symbols and information provided with medical devices Information provided wi
30、th medical devices supplied by the manufacturer EN 1618 : 1997 Catheters other than intravascular catheters Test methods for common properties EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements (ISO 594-1 : 1986)
31、 3 Definitions For the purposes of this European standard, the following definitions apply. 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. 3.2 balloon capacity Volume of liqui
32、d 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. 4 Requirements
33、 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 manufacturers instructions) and is examined by normal or corrected-to-normal vision at 2,5 times magnification, the surface of t
34、he shaft, tip, balloon and eyes shall appear free from extraneous matter. 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 sh
35、all 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 1 (see also figure 1).Page 4 EN 1616 : 1997 BSI 08-1999 1. Drainage funnel 2. Inflation funnel 3. Valve 4. Irrigation funnel L is the overal
36、l length S is the effective length Figure 1. Typical urethral catheters a) without and b) with balloonPage 5 EN 1616 : 1997 BSI 08-1999 Table 2. Average flow rates Designated size Average flow rate (minimum) Outside diameter Charrie re equivalent 1) Drainage lumen Irrigation lumen mm FG/Ch/Fr ml/min
37、 ml/min 2,0 6 10 n.a. 2) 2,7 8 15 n.a. 3,3 10 30 n.a. 4,0 12 50 n.a. 4,7 14 70 25 5,3 16 100 25 6,0 18 100 25 6,7 20 100 25 7,3 22 100 30 8,0 24 100 30 8,7 26 100 30 9,3 28 100 n.a. 10,0 30 100 n.a. 1) The Charrie re equivalent is given for information. 2) n.a. = not applicable. Table 1. Shaft dimen
38、sions Catheter type L (minimum) mm S (minimum) mm Paediatric without balloon 150 n.a. 1) Paediatric with balloon 220 150 Female without balloon 150 n.a. Female with balloon 220 130 Male without balloon 360 n.a. Male with balloon 360 275 1) n.a. = not applicable. 4.4 Strength When tested in accordanc
39、e 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
40、.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. 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 appr
41、oximately symmetrical expansion when filled with water at ambient temperature to its specified balloon capacity. 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 prep
42、ared 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 2. 4.9 Biocompatibility The device shall be evaluated for biocompatibility and shall be free from biological haza
43、rd. NOTE. Methods for evaluation for biocompatibility are given in EN 30993. 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. 5 Symbols and
44、 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 manufacturers stated minimum and maximum balloon inflation volumes; b) the designated size as given in 4.3.1.Page 6 EN 1616 :
45、 1997 BSI 08-1999 | 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 catheter
46、s 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 funne
47、l. On removal of this force, the catheter is examined for signs of failure. A.2 Reagents A.2.1 Simulated urine, pH approximately 6,6, of the following composition, the reagents being of recognized analytical grade: Urea 25,0 g Sodium chloride 9,0 g Disodium hydrogen orthophosphate, anhydrous 2,5 g A
48、mmonium 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
49、 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. 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 cat
