1、BSI Standards PublicationBS EN ISO 11990-1:2014Lasers and laser-relatedequipment Determinationof laser resistance of trachealtubesPart 1: Tracheal tube shaftBS EN ISO 11990-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11990-1:2014. It is identical t
2、o ISO 11990-1:2011. It supersedes BS ENISO 11990-1:2011 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CPW/172, Optics and Photonics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does
3、not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 88582 2ICS 11.040.10; 31.260Compliance with a British Standard cannot confer immunity froml
4、egal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11990-1 October 2014 ICS 11.040.10; 31.260 Supersed
5、es EN ISO 11990-1:2011English Version Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) Lasers et quipements associs aux lasers - Dtermination de la rsistance au laser des tubes trachaux - Partie 1: Axe des tubes
6、 trachaux (ISO 11990-1:2011) Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1: Trachealtubusschaft (ISO 11990-1:2011) This European Standard was approved by CEN on 22 October 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul
7、ate 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 CEN-CENELEC Management Centre or to any CEN member. This European St
8、andard 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the n
9、ational standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
10、Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any
11、means reserved worldwide for CEN national Members. Ref. No. EN ISO 11990-1:2014 EBS EN ISO 11990-1:2014EN ISO 11990-1:2014 (E) 3 Foreword The text of ISO 11990-1:2011 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO
12、) and has been taken over as EN ISO 11990-1:2014 by Technical Committee CEN/TC 123 “Lasers and photonics” the secretariat of which is held by DIN. 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 A
13、pril 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent
14、rights. This document supersedes EN ISO 11990-1:2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, wh
15、ich is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Y
16、ugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11990-1:20
17、11 has been approved by CEN as EN ISO 11990-1:2014 without any modification. BS EN ISO 11990-1:2014EN ISO 11990-1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC (Medical Devices) This European Standard has been p
18、repared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union und
19、er that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that
20、 Directive and associated EFTA regulations. NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on Medical Devices Clause(s)/sub-clause(s) of th
21、is European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes This entire standard 7.1 (first indent only) This standard is intended to provide a test method that will allow an evaluation of the risk of ignition associated with the use of a tracheal tube and laser
22、s during ear, nose and throat surgery as part of the risk assessment as set out in these essential requirements. This entire standard 7.3 This entire standard 9.3 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN I
23、SO 11990-1:2014ISO 11990-1:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principle2 5 Significance and use of the test 3 6 Apparatus.3 6.1 Gas supply system3 6.2 Containment box .4 6.3 Smoke evacuation .
24、5 6.4 Lasers and delivery systems5 6.5 Oxygen analyser6 7 Reagents and materials 6 8 Preparation of test specimen .6 9 Preparation of apparatus6 10 Test procedure.7 11 Interpretation of results 8 12 Test report8 Bibliography10 BS EN ISO 11990-1:2014ISO 11990-1:2011(E) iv ISO 2011 All rights reserved
25、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 committees. Each member body interested in a subject for which a t
26、echnical 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 International Electrotechnical Commission (IEC) on all matters
27、 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 International Standards adopted by the technical committees are circulate
28、d to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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
29、for identifying any or all such patent rights. ISO 11990-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9, Electro-optical systems. This first edition of ISO 11990-1 cancels and replaces ISO 11990:2003, of which it constitutes a minor revision. ISO 11990 cons
30、ists of the following parts, under the general title Lasers and laser-related equipment Determination of laser resistance of tracheal tubes: Part 1: Tracheal tube shaft Part 2: Tracheal tube cuffs BS EN ISO 11990-1:2014ISO 11990-1:2011(E) ISO 2011 All rights reserved vIntroduction A fire in the airw
31、ay is always a serious matter. In addition to local damage in the larynx, injury can occur to the lower airway and the parenchymal tissue in the lung. The products of combustion can be blown into the lungs. Procedures performed in the airway where a tracheal tube and a laser are used bring together
32、an oxygen-enriched atmosphere, a fuel and high power, the three ingredients necessary to create a fire. The likelihood that a laser beam will contact the tracheal tube during airway procedures is high. In the early to mid-1980s, the increasing use of such lasers was followed by airway fires and, sub
33、sequently, the development of tracheal tubes designed specifically to be resistant to laser ignition and damage. Unfortunately, some of these tubes were not sufficiently resistant under operating room conditions, and airway fires continued to occur. These events led to the development of the test me
34、thod described in this part of ISO 11990, in order to assist the clinician in determining which tracheal tube shaft is most laser-resistant for a defined set of conditions. BS EN ISO 11990-1:2014BS EN ISO 11990-1:2014INTERNATIONAL STANDARD ISO 11990-1:2011(E) ISO 2011 All rights reserved 1Lasers and
35、 laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft 1 Scope This part of ISO 11990 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to ot
36、her components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2 (see Note 1). NOTE 1 ISO 11990-2 specifies the method for testing the laser resistance of the tracheal tube cuff. This part of ISO 11990 can be used to measure and describe the properties of materia
37、ls, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a
38、 fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use. NOTE 2 The direct applicability of the result of this test method to the clinical situation has not been fully established. CAUTION This test method can involve hazardous mate
39、rials, operations, and equipment. This part of ISO 11990 provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this part of ISO 11990 to establish appropriate safety and health practices and to
40、determine the applicability of regulatory limitations prior to use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced doc
41、ument (including any amendments) applies. ISO 11146-1, Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 1: Stigmatic and simple astigmatic beams 3 Terms and definitions For the purposes of this document, the following terms and
42、 definitions apply. 3.1 beam cross-sectional area A95smallest area containing 95 % of the total beam power ISO 11990-2:2010 BS EN ISO 11990-1:2014ISO 11990-1:2011(E) 2 ISO 2011 All rights reserved3.2 beam diameter d95 diameter of an aperture in a plane perpendicular to the beam axis which contains 9
43、5 % of the total beam power NOTE Adapted from ISO 11145. ISO 11990-2:2010 3.3 combustion any continuing burning process that occurs in or on the test specimen caused by a chemical process of oxidation with the liberation of heat EXAMPLES Flame, smouldering, rapid evolution of smoke. ISO 11990-2:2010
44、 3.4 damage any change, other than combustion, which may affect the safety of the patient or efficacy of the tracheal tube due to increasing the risk of ignition EXAMPLES Local heating, melting, creation of holes, pyrolysis. ISO 11990-2:2010 3.5 ignition creation of combustion induced by the deliver
45、y of power ISO 11990-2:2010 3.6 laser resistance measure of the ability of a material to withstand laser power without ignition or damage ISO 11990-2:2010 3.7 shaft portion of the tracheal tube between the cuff and the machine end of the tube 4 Principle WARNING This test method can result in a rock
46、et-like fire involving the tracheal tube. Such a fire can produce intense heat and light and toxic gases. To simulate worst-case conditions, the shaft of a tracheal tube is exposed to laser power of known characteristics while in an environment of (98 2) % oxygen. BS EN ISO 11990-1:2014ISO 11990-1:2
47、011(E) ISO 2011 All rights reserved 35 Significance and use of the test 5.1 This part of ISO 11990 describes a uniform and repeatable test method for measuring the laser resistance of the shaft of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have been fixed in
48、 order to establish a basis for comparison. This test method for measuring can be used to compare tracheal tubes having differing types and designs of laser protection. 5.2 A large number and range of variables are involved in ignition of a tracheal tube. A change in one variable can affect the outc
49、ome of the test. Caution should be observed, since the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE This method can be applied to study the effect of changing the test conditions, but this is outside the scope of this part of ISO 11990. For example, variation of the breathing-gas flow rate or different breathing-gas mixtures might affect the laser resistance of the shaft of a tracheal tube. 5.3 Since an oxygen-enriched atmosphere is often prese
