BS 3487-4-1988 Tracheal tubes - Specification for tubes of the Cole type《气管 第4部分 科尔型导气管规范》.pdf

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1、BRITISH STANDARD BS 3487-4: 1988 ISO 5361-4: 1987 Tracheal tubes Part 4: Specification for tubes of the Cole type UDC 616 089.5:615.477.82BS3487-4:1988 This British Standard, having been prepared under the direction of the Health Care Standards Committee, was published under the authority of the Boa

2、rd of BSI and comes into effect on 30November1988 BSI 08-1999 First published as BS3487 April1962 First part revision as BS3487-4 February1986 Second revision as BS3487-4 November1988 The following BSI references relate to the work on this standard: Committee reference HCC/45 Draft for comment 86/55

3、519 DC ISBN 0 580 16878 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Committee (HCC/-) to Technical Committee HCC/45, upon which the following bodies were represented: Association of Anaesthetists of Great Brit

4、ain and Ireland Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association British Association of Otolaryngologists British Health-care Trade and Industry Council British Paediatric Association British Rubber Manufactu

5、rers Association British Surgical Trades Association Incorporated Department of Health and Social Security Medical Sterile Products Association Amendments issued since publication Amd. No. Date of issue CommentsBS3487-4:1988 BSI 08-1999 i Contents Page Committees responsible Inside front cover Natio

6、nal foreword ii 0 Introduction 1 1 Scope and field of application 1 2 Reference 1 3 Definitions 1 4 General 1 5 Size designation 1 6 Size range 1 7 Dimensions 1 8 Bevel 1 9 Shoulder 1 10 Curvature of the tube 2 11 Marking 2 Figure Cole type tube 3 Table Dimensions of Cole tubes 2 Publications referr

7、ed to Inside back coverBS3487-4:1988 ii BSI 08-1999 National foreword This Part of BS3487 has been prepared under the direction of the Health Care Standards Committee. It is identical with ISO5361-4:1987 “Tracheal tubes Part4: Cole type”, which was published by the International Organization for Sta

8、ndardization (ISO) and prepared under the direction of Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment. This Part of BS3487 supersedes BS3487-4:1986, which is withdrawn. It includes a minor technical change to the tolerance in7.2 from that in the previous edition following revi

9、ew by ISO/TC121. The other Parts of BS3487 are: Part 1: Specification for all types of tubes; Part 2: Specification for oro-tracheal and naso-tracheal tubes of the Magill type (plain and cuffed); Part 3: Specification for tubes of the Murphy type; Part 5: Specification and methods of test for tube c

10、ollapse and cuff herniation. Terminology and conventions. The text of the International Standard has been approved as suitable for publication as a British Standard without deviation. Some terminology and certain conventions are not identical with those used in British Standards; attention is drawn

11、especially to the following. The comma has been used as a decimal marker. In British Standards it is current practice to use a full point on the baseline as the decimal marker. Wherever the words “part of ISO5361” appear, referring to this standard, they should be read as “Part of BS3487”. A British

12、 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. Cross-reference International Standard Correspondi

13、ng British Standard ISO5361-1:1984 BS3487 Tracheal tubes Part 1:1986 Specification for all types of tubes (Identical) Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages1 to 4, an inside back cover and a back cover. This standard has been updated (see

14、 copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS3487-4:1988 BSI 08-1999 1 0 Introduction This part of ISO5361 is one of a series of International Standards dealing with anaesthetic equipment and medical breathing ma

15、chines; it makes provision for tracheal tubes of the Cole type, i.e.the type with a small patient end for use with infants. The narrowest part of the infant airway is the non-distensible cricoid cartilage ring which is the main controlling factor during tracheal intubation. Consequently, the size of

16、 the tracheal portion is the limiting factor which determines the choice of size of tube to be used. Provision is made for a large number of sizes of tubes at close intervals so that the laryngo-tracheal portion of the Cole tube may easily fit the cricoid ring without causing trauma or undue resista

17、nce to gas flow. WARNING NOTE Users are cautioned that in clinical practice the shoulder must not exert pressure on the laryngeal tissues. The larger lumen in the oral portion of the Cole type is provided mainly to enable the use of a tracheal tube connector of larger size than would otherwise be po

18、ssible, to minimize resistance to gaseous flow and to facilitate the introduction of a suction catheter. 1 Scope and field of application This part of ISO5361 specifies general requirements for Cole tubes for use in infants. 2 Reference ISO 5361-1, Tracheal tubes Part 1: General requirements. 3 Defi

19、nitions For the purposes of this part of ISO5361, the definitions given in ISO5361-1 and the following definitions apply. 3.1 Cole tube specialized tracheal tube combining a short laryngo-tracheal portion of a small diameter and a longer oral portion of larger diameter with transition from one to th

20、e other resulting in a shoulder 3.2 laryngo-tracheal portion that portion of a Cole tube of small diameter extending from the bevel tip to the point at which there is an increase in the outside diameter 3.3 oral portion that portion of a Cole tube of a larger diameter extending from the machine end

21、to the point at which there is a decrease in the outside diameter 3.4 shoulder that portion of a Cole tube at which transition from the oral portion to the laryngo-tracheal portion occurs 4 General Cole tubes shall, unless otherwise specified, comply with the general requirements for tracheal tubes

22、specified in ISO5361-1. 5 Size designation The size of Cole tubes shall be designated by the nominal inside diameter of the tracheal portion of the tube, d 1(see the Figure), expressed in millimetres. 6 Size range The size range of Cole tubes shall be in accordance with the table. 7 Dimensions 7.1 T

23、he dimensions of Cole tubes shall be in accordance with the table and the figure. 7.2 The inside diameter (ID) shall be the nominal diameter subject to a tolerance ofmm. 8 Bevel 8.1 Cole tubes shall have a bevel of45 5 in relation to the axis of the tube. 8.2 The end of the tube at the bevel shall b

24、e rounded and the orifice(s) shall be free from sharp edges. 8.3 The bevel shall have the opening facing to the left when the tube is viewed towards the concave aspect from the machine end. 9 Shoulder 9.1 There shall be smooth transitional blending at the inside and outside surfaces between the trac

25、heal and oral portions of the tube. 9.2 The combination of the inside and outside profiles shall be such as to minimize kinking in the region of the shoulder. 9.3 The axial length of the outside surface of the shouldered region, S 1 S 2(see the Figure), shall not exceed4mm for sizes up to and includ

26、ing3mm.0,25 + 0BS3487-4:1988 2 BSI 08-1999 10 Curvature of the tube Cole tubes shall be smoothly curved to a radius of about60mm so that the machine end makes an angle of45 15 to the patient end as illustrated in the figure. The curvature shall start within20mm of the beginning of the taper (see S 1

27、in the Figure) on the outside surface. 11 Marking 11.1 In addition to the general requirements for marking given in ISO5361-1, Cole tubes shall be marked with the size, in accordance with clause5 and the table, together with the maximum outside diameter of the tracheal portion (OD; seetheFigure), in

28、 millimetres, and designated as shown in the following examples: TRACHEAL END ID 3,5/5,0 OD or ID 3,5/5,0 OD 11.2 The marking of the size of the Cole tube shall be situated on the bevelled side of the oral portion within the minimum length of the tube reading from the patient end to the machine end

29、(see the Figure). Table Dimensions of Cole tubes (see the Figure) Dimensions in millimetres Designation size a(nominal inside diameter of tracheal portion)d 1 Length of laryngo-tracheal portion C Oral portion Overall length A Inside diameter d 2 Outside diameter d 3 min. max. min. max. max. min. max

30、. 1,5 1,75 2,0 2,25 2,5 3,0 3,5 4,0 4,5 20 20 20 25 25 25 25 25 28 24 24 25 30 30 30 35 35 38 3,9 4,1 4,2 4,3 4,3 4,3 5,0 5,5 6,5 5,0 5,0 5,0 5,0 5,0 5,0 6,0 6,5 7,0 7,0 7,0 7,0 7,0 7,5 7,5 9,5 9,5 10,5 110 110 120 120 125 125 130 140 150 140 140 140 140 140 140 150 160 170 a For convenience in size

31、 designation, the second decimal place may be omitted.BS 3487-4:1988 BSI 08-1999 3 Figure Cole type tube4 blankBS3487-4:1988 BSI 08-1999 Publications referred to See national foreword.BS 3487-4: 1988 ISO 5361-4: 1987 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the

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