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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1733:1998 The Europ
2、ean Standard EN 1733:1998 has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Suction catheters for use in the respiratory tract Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:44 GMT+00:00 2006, Uncontrolled Copy, (c
3、) BSI 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 June 1998 BSI 1998 ISBN 0 580 29809 4 BS EN 1733:1998 Amendments issued since publication Amd. No.Dat
4、eText affected National foreword This British Standard is the English language version of EN 1733:1998. It supersedes BS 7213:1989 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/45, Tracheal tubes and related equipment, which has the responsibilit
5、y to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations r
6、epresented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspo
7、ndence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. 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 i
8、tself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 10, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:44 GMT+00:00 2006, Uncontrolled Copy, (c)
9、 BSI 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 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1733
10、:1998 E EUROPEAN STANDARDEN 1733 NORME EUROPE ENNE EUROPA ISCHE NORM February 1998 ICS 11.040.10; 11.040.20 Descriptors: Medical equipment, tracheal tubes, specifications, definitions, designation, dimensions, design, mechanical strength, tests, packing, marking, labelling English version Suction ca
11、theters for use in the respiratory tract Sondes daspiration pour les voies respiratoiresAbsaugkatheter zur Verwendung im Atemtrakt This European Standard was approved by CEN on 5 July 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for g
12、iving 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 Standard exists in three official ve
13、rsions (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
14、, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 1733:19
15、98 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the secretariat of which is held by BSI. This European Standard is based on ISO 8836:1988 Suction catheters for use in the respiratory tract, prepared by ISO/TC 121
16、. However, it differs from ISO 8836 in that it introduces a table of colour identification for use with suction catheters. It no longer includes requirements for suction catheters made of rubber, and the size should be designated by outside diameter expressed in millimetres. Annexes A, B and C are n
17、ormative and form part of this European Standard. Annexes D and E are for information only. 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 1998, and conflicting national standards shall be
18、 withdrawn at the latest by August 1998. 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, It
19、aly, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Size designation and dimensions4 5Materials5 6Design5 7Performance requirements5 8Requirements for suction catheters
20、supplied sterile6 9Marking6 Annex A (normative) Test method for security of fit of female ends8 Annex B (normative) Test method for security of construction9 Annex C (normative) Test method for residual vacuum9 Annex D (informative) Guidance on design and materials10 Annex E (informative) Bibliograp
21、hy10 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1733:1998 BSI 1998 Introduction This European Standard specifies dimensions and requirements for suction catheters for use in the respiratory tract. Size is designated by outside
22、 diameter which is important when selecting catheters, because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube (see prEN 1782 for details of tracheal tube standards and EN 1282-1 and EN 1282-2 for details of tracheostomy tube standards).
23、Requirements for suction catheters made of rubber have been deleted because such catheters are no longer in general use. Flammability of suction catheters, for example if flammable anaesthetics or lasers are used, is a well-recognized hazard that is addressed by appropriate clinical management, and
24、is outside the scope of this standard. 1 Scope This European Standard specifies requirements for suction catheters made of plastics materials and intended for use in suction of the respiratory tract. Specialized suction catheters are excluded from the scope of this standard. Angled tip suction cathe
25、ters (e.g. Coude catheters) are not considered to be specialized and are therefore included in the scope. 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 th
26、e 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 a
27、pplies. EN 556:1994, Sterilization of medical devices Requirements for medical devices to be labelled STERILE. EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods. EN 30993-1, Biological evaluation of medical devices
28、Part 1: Guidance on selection of tests. (ISO 10993-1:1992 + Technical Corrigendum 1:1992) ISO 468, Surface roughness Parameters, their values and general rules for specifying requirements. 3 Definitions For the purposes of this European Standard, the following definitions apply. 3.1 adaptor speciali
29、zed connector to establish functional continuity between otherwise disparate or incompatible components 3.2 connector fitting to join together two or more components EN ISO 4135:1996 3.3 effective shaft length the main part of the catheter which is of uniform outside diameter 3.4 eye lateral apertur
30、e near the patient end of the catheter EN ISO 4135:1996 3.5 machine end that end of the catheter which is intended to be connected to a source of vacuum EN ISO 4135:1996 3.6 patient end that end of the catheter which is intended to be inserted into the patient EN ISO 4135:1996 3.7 residual vacuum th
31、e negative pressure at the patient end of the suction catheter when the vacuum control device is in the relief position 3.8 suction catheter flexible tube designed for introduction into a respiratory tract to remove material by suction EN ISO 4135:1996 3.9 tip extremity of the patient end of a cathe
32、ter EN ISO 4135:1996 3.10 vacuum control device means provided at the machine end of a catheter to control the flow of air and entrained material EN ISO 4135:1996 3.11 terminal orifice central opening of the patient end of the suction catheter Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 0
33、8:03:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1733:1998 BSI 1998 Table 1 Colour identification for designated size of suction catheter Designated sizeColour identification Nominal outside diameter (mm) French (Charrie re) size equivalent 1,675grey 2,06light green 2,57,5pink 2,678light
34、 blue 3,09turquoise 3,3310black 4,012white 4,6714green 5,015brown 5,3316orange 6,018red 6,6720yellow Table 2 Basic dimensions of suction catheters Metric sizes Designated sizeOutside diameter toleranceMinimum inside diameter mmmm Nominal outside diameterFrench (Charrie re) size equivalent1) mm 1,54,
35、5 F 0,1 0,8 26 F 0,1 1,05 2,57,5 F 0,1 1,45 39 F 0,15 1,75 412 F 0,15 2,45 515 F 0,2 3,2 618 F 0,2 3,9 1)The letters Ch can replace the letter F in the size designation (see 4.1.1); 1 F or 1 Ch corresponds to one-third of a millimetre for the outside diameter see also 9.3b) and 9.4b). 4 Size designa
36、tion and dimensions 4.1 Size designation 4.1.1 The size of suction catheters shall be designated by the following: a) the outside diameter of the effective shaft length, expressed in millimetres; NOTEIt can additionally be expressed in French (Charrie re) gauge size. b) the nominal effective shaft l
37、ength, expressed in millimetres. 4.1.2 The size of the catheter can additionally be designated by the use of colour identification at the machine end. If a colour code is used it shall be in accordance with Table 1. 4.2 Dimensions 4.2.1 The outside diameter and the minimum inside diameter of suction
38、 catheters excluding at the tip shall be in accordance with Table 2 or Table 3. NOTEFor the purposes of this European Standard, the French (Charrie re) gauge system of size is based on the outside diameter of the shaft gauged in steps of thirds of a millimetre (1 millimetre corresponds to 3F); the F
39、rench gauge size is not an SI unit. Size designation in millimetres facilitates matching suction catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube. 4.2.2 The minimum inside diameter at the tip shall be not less than 90 % of the minimum inside diameter specified in
40、 Tables 2 and 3. 4.2.3 The actual effective shaft length shall be the marked effective length subject to a tolerance of5 %. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 1733:1998 BSI 1998 Table 3 Basic dimensions of suction cath
41、eters French (Charrie re) sizes Designated sizeOutside diameter tolerance (mm) Minimum inside diameter (mm) French size1)Outside diameter equivalent1) (mm) 4 F1,33 0,1 0,55 5 F1,67 0,1 0,8 6 F2 0,1 1,05 8 F2,67 0,1 1,5 10 F3,33 0,15 2 12 F4 0,15 2,45 14 F4,67 0,2 2,95 16 F5,33 0,2 3,4 18 F6 0,2 3,9
42、20 F6,67 0,2 4,3 1)The letters Ch can replace the letter F in the size designation (see 4.1.1); 1 F or 1 Ch corresponds to one-third of a millimetre for the outside diameter see also 9.3b) and 9.4b). 5 Materials Suction catheters for use in the respiratory tract, in their ready-for-use state after a
43、ny preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in EN 30993-1. NOTEIt is recommended that the shaft be colourless and either transparent or translucent 6 Design 6.1 Lumen The inside diameter of the shaft at any point between t
44、he machine end and the eye nearest to the machine end shall be not less than the inside diameter of the shaft at that eye. 6.2 Patient end 6.2.1 The catheter shall have a terminal orifice. NOTE 1The catheter can have one or more eyes. NOTE 2The use of a catheter with eye(s) can reduce the likelihood
45、 of trauma during suctioning. NOTE 3The dimensions of the eye(s) should be such that they do not cause the suction catheter to kink or collapse in use. 6.2.2 The axis of the patient end can be at an angle to the long axis of the shaft (see Coude catheter tip in Figure 1). 6.3 Machine end 6.3.1 The m
46、achine end of the suction catheter shall be either: a) female designed to receive a male-to-male adaptor suitable for connection to a vacuum source that terminates in a female end; or b) male designed for connection to a vacuum source that terminates in a female end; or c) a permanently attached vac
47、uum control device that terminates in either a male or female end. 6.3.2 Female ends shall be semi-rigid or elastomeric and shall be either conical or cylindrical (see Figure 1) over a length of not less than 20 mm for suction catheters with outside diameters of up to and including 3 mm and not less
48、 than 25 mm for suction catheters of outside diameters greater than 3 mm. NOTEWhere a suction catheter with a female machine end is provided for use with a vacuum source with a female end, a male-to-male adaptor is needed (see Figure 1). The minimum inside diameter of the adaptor should be not less
49、than the minimum inside diameter of the suction catheter with which it is provided. The adaptor should fit inside elastomeric tubing having an inside diameter of 6 mm. 6.3.3 Male ends (see Figure 1) shall be rigid or semi-rigid and shall fit inside semi-rigid or elastomeric tubing having an inside diameter of 6 mm. NOTEIt is advantageous if the male end fits inside semi-rigid or elastomeric tubing with a larger inside diameter which can be used in emergency to clear the airway. 6.3.4 The mach