1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1618 : 1997 The Eur
2、opean Standard EN 1618 : 1997 has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Catheters other than intravascular catheters Test methods for common propertiesBS EN 1618 : 1997 This British Standard, having been prepared under t
3、he 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 1997 The following BSI references relate to the work on this standard: Committee reference CH/27 Draft for comment 94/506466 DC ISBN 0 580 27654
4、 6 Amendments issued since publication Amd. No. Date Text affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/27, Medical plastics tubing, upon which the following bodies were represented: Association of Anaesthet
5、ists of Great Britain and Ireland Association of British Health-care Industries British Dietetic Association (PENG) British Surgical Trades Association Department of Health Disposable Hypodermic and Allied Equipment Manufacturers Association (UK) Guild of Hospital Pharmacists Institution of Physics
6、and Engineering in Medicine and Biology Intensive Care Society Medical Sterile Products Association National Association of Theatre Nurses Royal College of Paediatrics and Child Health Royal Pharmaceutical Society of Great BritainBS EN 1618 : 1997 BSI 1997 i Contents Page Committees responsible Insi
7、de front cover National foreword ii Foreword 2 Text of EN 1618 3ii BSI 1997 BS EN 1618 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/27 and is the English language version of EN 1618 : 1997 Catheters other than intravascular catheters Test methods for com
8、mon properties, published by the European Committee for Standardization (CEN). 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 2 to 8,
9、 an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. EN 1618 : 1997 E EUROPEAN STANDARD EN 1618 N
10、ORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.040.20 Descriptors: Medical equipment, catheters, tests, characteristics, corrosion resistance, mechanical strength, leaktightness, flow rate English version Catheters other than intravascular catheters Test methods for common properties Cathe
11、ters autres que les cathe ters intravasculaires M e thodes dessai des proprie te s communes Nicht-intravasale Katheter Pru fverfahren fu r allgemeine Eigenschaften This European Standard was approved by CEN on 1997-01-10. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whic
12、h 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 Central Secretariat or to any CEN member. This European Stan
13、dard 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 stan
14、dards 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 1618 : 1997 BSI 1997 Foreword This European Standard has been prepared by Technical Committee CEN/T
15、C 205, Non-active medical devices, the secretariat of which is held by BSI. 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 the EU Directive(s). This European Standard sha
16、ll 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. For relationship with EU Directive(s), see informative annex ZA, which is an
17、integral part of this standard. Annexes A, B, C, D, E and F form normative parts of this standard. Annex ZA is 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: Austr
18、ia, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 1 Scope 3 2 Test methods and results 3 Annexes A (normative) Test method for corrosion resistance of
19、 metallic components 4 B (normative) Test method for tensile properties 4 C (normative) Test method for resistance to liquid leakage under pressure 5 D (normative) Test method for resistance to leakage during aspiration or vacuum 5 E (normative) Test method for determining the flow rate of water thr
20、ough the catheter 5 F (normative) Test method for security of connectors 7 ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 7Page 3 EN 1618 : 1997 BSI 1997 1 Scope This European Standard specifies test methods for common proper
21、ties for catheters as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of catheter properties. This European Standard is not applicable to intravascular catheters. 2 Test methods and results The test methods are given in annexes
22、A to F and results shall be expressed as, e.g.: Corrosion test according to EN 1618: No sign of corrosion. Unless otherwise specified, tolerances on all variables in the test methods shall be 10 %.Page 4 EN 1618 : 1997 BSI 1997 Annex A (normative) Test method for corrosion resistance of metallic com
23、ponents A.1 Principle The catheter is immersed in the sodium chloride solution, then in boiling distilled water, and afterwards the metallic components are examined visually for evidence of corrosion. A.2 Reagents A.2.1 Saline solution, comprising 0,9 % m/V of analytical reagent grade sodium chlorid
24、e in freshly prepared, distilled water. A.2.2 Distilled or deionized water. A.3 Apparatus Borosilicate glass beakers. A.4 Procedure Immerse the catheter in the saline solution (A.2.1)i na glass beaker (A.3) at (23 2) C for 5 h. Remove the test specimen and immerse it in boiling distilled water (A.2.
25、2) for 30 min. Allow the water and the test specimen to cool to, and remain at, (23 2) C for 48 h. Remove the test specimen and allow it to dry at (23 2) C. Disassemble specimens that have two or more components which are intended to be separable in use. Do not strip away or cut open any opaque coat
26、ings on metallic components. Inspect the metallic components of the specimen visually for signs of corrosion. A.5 Test report The test report shall include the following information: a) identity of catheter; b) statement as to whether corrosion occurred during the test. Annex B (normative) Test meth
27、od for tensile properties B.1 Principle Test pieces of a catheter are chosen so that each tubular portion, each junction between hub or connector and tubing, and each junction between tubular portions is tested. A tensile force is applied to each test piece until the tubing breaks or the junction se
28、parates or until a specified force is applied. B.2 Apparatus Tensile testing apparatus, capable of exerting a force of greater than 15 N. B.3 Procedure B.3.1 Condition those parts of the catheter that are intended for insertion into the body in an atmosphere of 100 % relative humidity (RH), or water
29、, and a temperature of (37 2) C for 2 h. Condition the remainder of the catheter at 40 % RH to 60 % RH and a temperature of (23 2) C. Test immediately after conditioning. B.3.2 Select a test piece from the catheter to be tested. Include in the test piece the hub or connector, if present, and the jun
30、ction between segments, e.g. between the tubing and the tip, if present. Exclude distal tips of lengths less than 3 mm from the test piece. B.3.3 Fix the test piece in the tensile testing apparatus. If a hub or connector is present, use an appropriate fixture to avoid deforming the hub or connector.
31、 B.3.4 Measure the gauge length of the test piece (i.e. the distance between the jaws of the tensile testing apparatus or the distance between the hub or connector and the jaw holding the other end of the test piece, as appropriate). B.3.5 Apply a tensile strain at a unit strain rate of 20 mm/min/pe
32、r millimetre of gauge length (see table B.1) until the test piece separates into two or more pieces, or until a specified force is applied. Note the value of the applied tensile force, in newtons. Table B.1 Example of conditions for a 20 mm/min strain rate per millimetre of gauge length Gauge length
33、 Testing speed (mm) (mm/min) 10 200 20 400 25 500 B.3.6 If testing a catheter that consists of a single tubular portion having regions of different outside diameter, repeat B.3.2 to B.3.5 on test pieces of each different diameter. B.3.7 If testing a catheter that has a side port or side ports: a) re
34、peat B.3.2 to B.3.5 on each side port; b) repeat B.3.2 to B.3.5 on a test piece that includes the joint between a side port and the adjacent part of that portion of the catheter intended to be introduced into the body; c) repeat B.3.7b) for each joint. B.3.8 Do not perform more than one test on each
35、 test piece. B.4 Test report The test report shall include the following information: a) identity of the catheter; b) the force at break, or the specified force applied, and outside diameter of each test piece.Page 5 EN 1618 : 1997 BSI 1997 Annex C (normative) Test method for resistance to liquid le
36、akage under pressure C.1 Principle The test piece is connected as intended by the manufacturer and filled with water. A connection is made to a pressure system with a measuring gauge. A hydraulic pressure is applied and the assembly is then inspected for leakage. C.2 Reagent De-aerated distilled or
37、deionized water. C.3 Apparatus C.3.1 A hydraulic pressure system, with a measuring gauge. C.3.2 Means for occluding the test specimen, e.g. a clamp. C.3.3 Connector, capable of making a leak proof coupling between the hydraulic system and the device. C.4 Procedure C.4.1 Connect the connector to the
38、hydraulic pressure system (C.3.1). C.4.2 Fill the system with water (C.2) at (23 2) C and expel the air. Occlude the test specimen (C.3.2). C.4.3 Apply the test pressure and maintain it for not less than 30 s. Examine the total assembly for any liquid leakage (i.e. the formation of one or more falli
39、ng drops of water) and record whether or not leakage occurs. NOTE. The test pressure is specified in the relevant product standard. C.5 Test report The test report shall include the following information: a) identity of the catheter; b) test pressure; c) statement as to whether and where leakage occ
40、urred from the assembly. Annex D (normative) Test method for resistance to leakage during aspiration or vacuum D.1 Principle The catheter is connected as intended by the manufacturer and filled with water. A connection is made to a source of negative pressure with a measuring gauge. A negative press
41、ure is applied and the assembly is allowed to stabilize. The assembly is then inspected for leakage. D.2 Reagent De-aerated distilled or deionized water. D.3 Apparatus D.3.1 A differential pressure system, with a measuring gauge. D.3.2 Means for occluding the test specimen, e.g. a clamp. D.3.3 Means
42、 of detecting air ingress, if the test specimen is not transparent. D.3.4 Leak-proof connector. D.3.5 Hydraulic pressure system, as specified in C.3.1. D.4 Procedure D.4.1 Connect the connector to the hydraulic pressure system (D.3.5). D.4.2 Fill the system with water (D.2) at (23 2) C and expel the
43、 air. Occlude the test specimen (D.3.2). D.4.3 Apply a negative pressure and allow the system to stabilize for 120 s. Leave the system under negative pressure for another 120 s. During this period examine the assembly for leakage (i.e. the formation of one or more bubbles of air) and record whether
44、or not leakage occurs. NOTE. The test pressure is specified in the relevant product standard. D.5 Test report The test report shall include the following information: a) identity of the catheter; b) test negative pressure; c) statement as to whether and where leakage occurred from the assembly. Anne
45、x E (normative) Test method for determining the flow rate of water through the catheter E.1 Principle Water is allowed to flow through the catheter and the amount of flow is measured either volumetrically or gravimetrically. E.2 Apparatus E.2.1 A constant level tank, fitted with a delivery tube and
46、a male (or female) taper fitting capable, when no test catheter is attached, of providing a flow rate of not less than 500 ml/min. The constant level tank should have a hydrostatic head of height (1000 10) mm, unless otherwise specified in the relevant product standard. An example of suitable appara
47、tus is shown in figure E.1. E.2.2 Measuring cylinders, or collecting vessel with balance of accuracy 1% . E.3 Procedure E.3.1 Supply the constant level tank with water at (22 2) C. Fit the catheter to be tested to the appropriate connector. E.3.2 Flush air from the system by allowing water to flow b
48、riefly through the catheter. E.3.3 Start the water flowing through the catheter. Collect the efflux for a period of not less than 30 s in a suitable vessel and determine its volume by means of a measuring cylinder or by weighing using the assumption that the density of water equals 1000 kg/m 3 . Per
49、form three determinations on each catheter.Page 6 EN 1618 : 1997 BSI 1997 3 2 1 8 5 4 6 7 1000 10 Dimensions in millimetres 1. Constant level tank 5. Tube, 10 mm internal diameter, length 1000 mm min. 2. Water 6. Appropriate connector 3. Inlet 7. Catheter 4. Overflow 8. Collecting/measuring vessel Figure E.1 Example of apparatus for determination of flow rate of water through the catheterPage 7 EN 1618 : 1997 BSI 1997 E.4 Expression of results Calculate the arithmetic average of the three determinations an
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