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1、DRAFT FOR DEVELOPMENT DD ISO/TS 16628:2003 Tracheobronchial tubes Recommendations for size designation and labelling ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD ISO/TS 16628:2003 This Dra
2、ft for Development, was published under the authority of the Standards Policy and Strategy Committee on 11 September 2003 BSI 11 September 2003 ISBN 0 580 42604 1 National foreword This Draft for Development reproduces verbatim ISO/TS 16628:2003 This publication is not to be regarded as a British St
3、andard. It is being issued in the Draft for Development series of publications and is of a provisional nature because the document may form the basis of a full ISO standard in due course. It should be applied on this provisional basis, so that information and experience of its practical application
4、may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for the Technical Specification. A review of this publication will be initiated not later than 3 years after its publication
5、by the international organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the review perio
6、d, the responsible BSI Committee will decide whether to support the conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee CH/121/2, Tracheal tubes and
7、 related equipment, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. Cross-references The British Standards which implement international or European publications referred to in this document
8、 may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. Summary of pages This document comprises a front cover, an inside front cover, the ISO/TS ti
9、tle page, pages ii to v, a blank page, pages 1 to 7 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University,
10、Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO/TS 16628:2003(E) OSI 3002 TECHNICAL SPECIFICATION ISO/TS 16628 First edition 2003-08-01 Tracheobronchial tubes Recommendations for size designation and labelling Sondes tracho-bronchiques Recommandations pour la dsig
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16、+ 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o gro ii ISO 3002 Allr ihgtsser edevr DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS/OTS :82661(3002)E I SO 30
17、02 All irhgts seredevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Terms and definitions.1 3 General requirements.1 3.1 Size designation of bronchial segment1 3.2 Nominal maximum bronchoscope diameter1 3.3 Colour coding1 3.4 Segment differentiation1 4 Marking.2 4.1 Use of symbols2 4.2 Mar
18、king of tracheobronchial tubes.2 4.3 Marking on tracheobronchial tube individual pack and any insert .3 Annex A (informative) Determination of circumference of bronchial segment of tracheobronchial tubes.4 A.1 Principle.4 A.2 Apparatus.4 A.3 Procedure.4 A.4 Expression of results4 Annex B (informativ
19、e) Determination of nominal maximum bronchoscope diameter5 B.1 Principle.5 B.2 Apparatus.5 B.3 Procedure.5 B.4 Expression of results6 Bibliography .7 DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy,
20、 (c) BSI IS/OTS :82661(3002)E iv I SO 3002 All irhgts seredevr Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical com
21、mittees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
22、 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft Internatio
23、nal Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such
24、documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of
25、the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three year
26、s in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard
27、or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 16628 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respira
28、tory equipment, Subcommittee SC 2, Tracheal tubes and other equipment. DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS/OTS :82661(3002)E I SO 3002 All irhgts seredevr v Introduction This
29、 Technical Specification is intended to provide recommendations to assist manufacturers in establishing a standard method of size designation for tracheobronchial tubes and their parts. A tracheobronchial tube is a double-lumen tracheal tube that facilitates selective ventilation to one or both lung
30、s. It is designed for either right or left mainstem bronchus placement, and has both a tracheal and a bronchial cuff. DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank DD ISO/TS 16628:2
31、003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI TECINHCAICEPS LFICATION IS/OTS :82661(3002)E I SO 3002 All irhgts seredevr 1 Tracheobronchial tubes Recommendations for size designation and labelling 1 Scope
32、 This Technical Specification provides recommendations for the size designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of this Technical
33、 Specification. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 tracheobronchial tube double-lumen tube designed for insertion through the larynx into the trachea and a main stem bronchus to separate right and left lung ventilation 3 General
34、requirements 3.1 Size designation of bronchial segment The size of the bronchial segment of the tube should be designated by the outside circumference measured at the mid-point of the bronchial cuff (see 1 in Figure 1), in millimetres 0,5 mm, determined in accordance with Annex A. 3.2 Nominal maximu
35、m bronchoscope diameter The nominal maximum bronchoscope diameter (representing the maximum size of bronchoscope that will pass through the lumina of the bronchial and tracheal segments of the tube) should be determined in accordance with Annex B. 3.3 Colour coding The bronchial cuff and its associa
36、ted pilot balloon should be entirely coloured blue. 3.4 Segment differentiation The tracheal and bronchial segments should be clearly distinguishable from each other when viewed from the machine end. DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun
37、Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS/OTS :82661(3002)E 2 I SO 3002 All irhgts seredevr Key 1 point of measurement of circumference of tracheobronchial tube 2 bronchial segment 3 cross-section of tracheal lumen (not necessarily circular) 4 cross-section of bronchial lumen (no
38、t necessarily circular) 5 patient end of bronchial segment 6 patient end of tracheal segment 7 tracheal cuff 8 bronchial cuff Figure 1 Typical example of a tracheobronchial tube 4 Marking 4.1 Use of symbols 4.1.1 The recommendations of 4.2 may be met by the appropriate symbols given in ISO 70001 or
39、ISO 155232. 4.1.2 Marking of tracheobronchial tubes, packages and inserts and information to be supplied by the manufacturer should comply with EN 10413. 4.2 Marking of tracheobronchial tubes 4.2.1 Marking of the tracheobronchial tube should include the following: a) the name and/or trademark of the
40、 manufacturer or supplier; b) the manufacturers stated size; c) the circumference of the bronchial segment, in accordance with 3.1 and prefixed “Br”; d) for tracheobronchial tubes for single use, the words “single-use” or equivalent; DD ISO/TS 16628:2003 Licensed Copy: London South Bank University,
41、London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS/OTS :82661(3002)E I SO 3002 All irhgts seredevr 3 e) length marks at 20 mm intervals, measured from the tip of the bronchial segment and marked on the proximal end of the tracheal segment; f) the word “ri
42、ght” or “left”, as appropriate. 4.2.2 Marking should be of a colour that contrasts with the colour of the tube. 4.3 Marking on tracheobronchial tube individual pack and any insert The following should be marked on, or visible through, the tracheobronchial tube individual pack and may additionally be
43、 given on an insert: a) a description of the contents; b) the word “right” or “left”, as appropriate; c) the manufacturers stated size; d) the circumference of the bronchial segment, in accordance with 3.1 and prefixed “Br”; e) the nominal maximum bronchoscope diameter, determined in accordance with
44、 3.2; f) the name and/or trademark of the manufacturer; g) the batch number; NOTE It is strongly recommended that the “use-by” date be given. h) the word “STERILE”, if appropriate; NOTE It is recommended that the method of sterilization be given. i) for tubes not intended for re-use, the words “sing
45、le-use” or equivalent; j) an indication of the presence of natural rubber (latex), if present in the device; k) instructions for cleaning and disinfecting or sterilizing, unless the tube is intended and marked as being for single use, l) recommendations for an appropriate sterilization method, if de
46、livered non-sterile. DD ISO/TS 16628:2003 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:20:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS/OTS :82661(3002)E 4 I SO 3002 All irhgts seredevr Annex A (informative) Determination of circumference of bronchial s
47、egment of tracheobronchial tubes A.1 Principle The circumference of the bronchial segment of the tracheobronchial tube is measured by wrapping an inelastic wire or thread around the outside of the bronchial segment of the tube and subsequently measuring the length of the wire or thread. A.2 Apparatu
48、s A.2.1 Length of inelastic wire or thread, sufficiently long to be wrapped around the outside of the bronchial segment of the tube five times at the mid-point of the bronchial cuff (see 1 in Figure 1). A.2.2 Means of measuring the length of the inelastic wire or thread (A.2.1) in millimetres. A.3 P
49、rocedure A.3.1 Wrap a piece of inelastic wire or thread (A.2.1) in a close spiral five times around the outside of the bronchial segment of the tube, at the mid-point of the bronchial cuff. A.3.2 Measure the length of the inelastic wire or thread in millimetres. A.3.3 Determine the circumference of the bronchial segment of the tracheobronchial tube by dividing the length by five. A.4 Expression of results Express the circumference of the bronchial segmen