1、STD-BSI BS EN 1b1B-ENGL 1997 I 1b2Libb b22769 07Li m BRITISH STANDARD Catheters other than intravascular catheters - Test methods for common properties The European Standard EN 1618 : 1997 has the status of a British Standard ICs 11.040.20 BS EN 1618 : 1997 NO COPYING WITHOUT BSI PERMISSION EXCEPT A
2、S PERMITTED BY COPYRIGHT LAW I BS EN 1618 : 1997 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee Cw27, Medical plastics tubing, upon which the following bodies were represented: This Briish Standard, having been prepared
3、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 O BSI 1997 Association of hsthetists of Great Britain and Ireland Association of British Healthare Industries British Dietetic Association (P
4、ENG) British Surgical Wes Association Department of Health Disposable Hypodermic and Alied Equipment Manufacturers Association 0 Guild of Hospital Pharmacists Institution of Physics and Engineering in Medicine and Biology Intensive Care Society Medical Sterie Products Association National Associatio
5、n of Theatre Nms Royal College of Paediatrics and Child Health Royal Phaceutical Society of Great Britain Amendments issued since publication ID* I %*affected The following BSI references relate to the work on this standard Committee reference CHE7 Draft for comment 94506466 DC ISBN O 680 27654 6 -
6、- STD-BSI BS EN LbliA-ENGL 1997 1b24bb7 Ob22771 722 BS EN 1618 : 1997 * * rn O BSI 1997 Contents Committees responsible National foreword me inside front cover ii Foreword Text of EN 1618 2 3 i National foreword This British Standard has been prepared by Technical Committee CHE7 and is the English l
7、anguage version of EN 1618 : 1997 Catheters other thun intmvasCuEar catheters - Test methods for common 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 docum
8、ent comprises a front cover, an inside front cover, pages i and ii, the EN titie page, pages 2 to 8, an inside back cover and a back cover. ii O BSI 1997 STD-BSI BS EN LbLd-ENGL 1177 m lb24bb9 Ob22773 5TS EUROPEAN STANDARD EN 1618 NORME EUR0PEE”E EUROPAscHE NORM February 1997 ICs 11.040.20 Descripto
9、is: Medid equipment, catheters, tests, characteristics, corrosion resistance, mechanical strength, leakghtness, flow rate English version Cathetern other than Intravascular cathetern - Test methods for common properties Cathters autres que les cathters intra- - Mthodes dessai de proprits mmune Nicht
10、-intravasale Katheter - pritfverfahren fur aligemeine Eigenschaften This European standard was approved by CEN on 1997-01-10. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipula the conditions for giving this European Standard the status of a national standard with
11、out any alteration. Upto-date lists and bibliogcaphical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, Geman). A version in any other language mad
12、e by transkition under the responsibility of a CEN member int its own hguage and notified to the Centrai Secretariat has the same status as the officia versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lux
13、embourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and Unit c) statement as to whether and where leakage occurred from the assembly. Annex D (normative) Test method for resistance to leakage during aspiration or vacuum D.l Principle The catheter is connected as intended by the manufa
14、cturer and iled with water. A connection is made to a source of negative pressure with a measuring gauge. A negative pressure is appiied and the assembly is allowed to stabilize. The assembly is then inspected for leakage. D.2 Reagent Deaerated distilled or deionized water. D.3 Apparatus D3.1 A d.i,
15、fferential psure system, with a measuring gauge. D.3.2 Means for occluding ule test specimen, e.g. a clamp. Page 5 EN 1618 : 1997 D.3.3 Meam of detecting air ingress, if the test specimen is not transparent. D.3.4 Lmk-pmof connector. D.3.6 Hydraulic pasure system, as specified in C.3.1. D.4 Procedur
16、e D.4.1 Connect the connector to the hydraulic pressure system 0.3.6). D.4.2 Fiil the system with water (D.2) at (23 f 2) “C and expel the air. Occlude the test specimen 0.3.2). D.4.3 Apply a negative pressure and ailow the system to stabilize for 120 s. Leave the system under negative pressure for
17、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 or not leakage OCCUIS. NOTE. The test pressure is specified in the relevant product standard. D.6 Test report “he test report shal include the following informatio
18、n: a) identity of the catheter, b) test negative pressure; c) statement as to whether and where leakage occurred from the assembly Annex E (normative) ! c) specification for connector used ul *I O 7 o P Dimensions in millimetres 1. Constant level tank 5. lbbe, 10 mm internai diameter, length loo0 mm
19、 min. 2. Water 6. Appropriate connectar 3. inlet 7. Catheter 4. Overflow 8. Collectingmieasuring vessel Figure E.l Example of apparatus for determination of flow rate of water through the catheter Q BSI 1997 STDOBSI BS EN LbLB-ENGL 1977 m Lb24bb b22779 TL3 m Page 7 EN 1618 : 1997 Annex F (normative)
20、 %st method for security of connectors El Test for separation The connector(s) are assembled in accordance with the manufacturers instructions. A tensile force is applied and the assembled connection inspected for separation. F.2 Apparatus Tensile testing apparatus, capable of exerting a force of gr
21、eater than 15 N. E3 Procedure Assemble the connectors in accordance with the manufacturers instsuctions. Fix the assembled connectors in the tensile test apparatus (using an appropriate fixture to avoid deforming the connector, if necessary). Apply a tensile force, as specified in the product standa
22、rd, at a testing speed of 500 mm/min. Inspect the assembled connectors for separation. E4 Test report The test report sha include the following information: a) identity of the catheter, b) identity of the connector(s); c) force applied, in newtons and whether the connectors separated. Annex ZA (info
23、rmative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free We Association, and supports essential requirements of EU Directive
24、 93/42/EEC. WARNING. Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. The clauses of this standard are iikely to support essentiai requirements of Directive 93/42/EEC. Compliance with these clauses of this standard provides one
25、 means of conforming with the specific essential requirements of the Directive concerned and associated EFTA requirements. O BSI 1997 STD-BSI BS Ebl IibLA-ENGL 1997 R Lb24bL7 0b22.780 735 W BS EN 1618 : 1997 BSI 389 Chiswick High Road London w4 4AL BSI - British Standards Institution 3SI is the inde
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