BS EN ISO 11990-2-2014 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Tracheal tube cuffs《激光器和相关的激光设备 气管导管抗激光性的测定 气管导管袖带》.pdf

1、BSI Standards PublicationBS EN ISO 11990-2:2014Lasers and laser-relatedequipment Determinationof laser resistance of trachealtubesPart 2: Tracheal tube cuffsBS EN ISO 11990-2:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11990-2:2014. It is identical t

2、o ISO 11990-2:2010. It supersedes BS ENISO 11990-2:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CPW/172, Optics and Photonics.A list of organizations represented on this committee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 88583 9ICS 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 11990-2 October 2014 ICS 11.040.10; 31.260 Supersed

5、es EN ISO 11990-2:2010English Version Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010) Lasers et quipements associs aux lasers - Dtermination de la rsistance au laser des tubes trachaux - Partie 2: Ballonnet de

6、tubes trachaux (ISO 11990-2:2010) Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2: Trachealtubusmanschetten (ISO11990-2:2010) This European Standard was approved by CEN on 22 October 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whi

7、ch stipulate 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 Eu

8、ropean Standard 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

9、are the national 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,

10、Romania, 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 an

11、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11990-2:2014 EBS EN ISO 11990-2:2014EN ISO 11990-2:2014 (E) 3 Foreword The text of ISO 11990-2:2010 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” of the International Organization for Standardiza

12、tion (ISO) and has been taken over as EN ISO 11990-2:2014 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 la

13、test by April 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 suc

14、h patent rights. This document supersedes EN ISO 11990-2:2010. 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 Ann

15、ex ZA, which 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,

16、 Former Yugoslav 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 1

17、1990-2:2010 has been approved by CEN as EN ISO 11990-2:2014 without any modification. BS EN ISO 11990-2:2014EN ISO 11990-2:2014 (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 h

18、as been prepared 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

19、Union under 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 Requirement

20、s of that 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

21、(s) of this 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

22、and lasers 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

23、. BS EN ISO 11990-2:2014ISO 11990-2:2010(E) ISO 2010 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 2 6 Apparatus.3 6.1 Gas supply system3 6.2 Containment box .4 6.3 Smoke eva

24、cuation device.7 6.4 Lasers and delivery systems7 6.5 Oxygen analyser7 7 Reagents and materials 8 8 Preparation of test specimens .8 9 Preparation of apparatus8 10 Test procedure.9 11 Interpretation of results 10 12 Test report10 Bibliography11 BS EN ISO 11990-2:2014ISO 11990-2:2010(E) iv ISO 2010 A

25、ll rights reservedForeword 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 sub

26、ject 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 International Electrotechnical Commission (I

27、EC) 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 International Standards adopted by the technical commit

28、tees 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. 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

29、 held responsible for identifying any or all such patent rights. ISO 11990-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9, Electro-optical systems. ISO 11990 consists of the following parts, under the general title Lasers and laser-related equipment Determi

30、nation of laser resistance of tracheal tubes: Part 1: Tracheal tube shafts Part 2: Tracheal tube cuffs BS EN ISO 11990-2:2014ISO 11990-2:2010(E) ISO 2010 All rights reserved vIntroduction A fire in the airway is always a serious matter. In addition to local damage in the larynx, injury can occur to

31、the lower airway and the parenchymal tissue in the lung. The products of combustion may be blown into the lungs. Procedures performed in the airway, where a tracheal tube and a laser are used, bring together an oxygen-enriched atmosphere, a fuel and high power, the three ingredients necessary to cre

32、ate a fire. The likelihood that a laser beam will contact the tracheal tube during airway procedures is high. This led to the development of a test method, described in ISO 11990-1, to assist the clinician in determining which tracheal tube shaft was the most laser-resistant under a defined set of c

33、onditions. Unfortunately, fires with tracheal tubes, whose shafts were laser-resistant according to ISO 11990-1 have continued to occur. Investigations have shown that the cuff, and not the shaft, of the tracheal tube is the area of lowest laser resistance and most likely to be contacted by the lase

34、r beam, even when used according to the manufacturers instructions. Clinical experience has shown that not only perforation of the part of the shaft below the cuff has happened, but also ignition of the outer surface of the cuff. This could then ignite other parts of the tracheal tube, such as the t

35、ip, which is normally unprotected. BS EN ISO 11990-2:2014BS EN ISO 11990-2:2014INTERNATIONAL STANDARD ISO 11990-2:2010(E) ISO 2010 All rights reserved 1Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs 1 Scope This part of ISO 11990 sp

36、ecifies a method of testing the continuous wave (cw) resistance of the cuff regions of tracheal tubes designed to resist ignition by a laser. Other components of the system, such as the inflation system and shaft (as defined in ISO 11990-1), are outside the scope of this part of ISO 11990. NOTE 1 Th

37、e method for testing the laser resistance of the tracheal tube shaft is in the scope of ISO 11990-1. The specified test method can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not des

38、cribe or appraise the fire hazard or fire risk of materials, products or assemblies under actual clinical use conditions. However, the results of this test method may be used as an element of a fire risk assessment which takes into account all of the factors that are pertinent to an assessment of th

39、e hazard of a particular end use. NOTE 2 Caution should be observed in interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 3 This test method might involve hazardous materials, operations and equ

40、ipment. 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 test method to establish appropriate safety and health practices and determine the applicability of regu

41、latory 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 document (including any amendments) ap

42、plies. 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 definitions apply. 3.1 beam cross-

43、sectional area A95smallest area containing 95 % of the total beam power BS EN ISO 11990-2:2014ISO 11990-2:2010(E) 2 ISO 2010 All rights reserved3.2 beam diameter d95diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % of the total beam power NOTE Adapted from ISO 111

44、45:2006. 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 EXAMPLE Flame, smouldering, rapid evolution of smoke. 3.4 cuff inflatable balloon permanently attached around the tracheal tube near the

45、 patient end to provide an effective seal between the tube and the trachea ISO 5361:1999, definition 3.3 3.5 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 EXAMPLE Local heating, melting, cr

46、eation of holes, pyrolysis. 3.6 ignition creation of combustion induced by the delivery of power 3.7 laser resistance measure of the ability of a material to withstand laser power without ignition or damage 4 Principle WARNING This test method can result in a rocket-like fire involving the tracheal

47、tube. Such a fire can produce intense heat and light and toxic gases. To simulate worst-case conditions, the cuff of a tracheal tube is exposed to laser power of known characteristics in an environment of 98 % 2 % oxygen. 5 Significance and use of the test 5.1 This part of ISO 11990 describes a unif

48、orm and repeatable test method for measuring the laser resistance of the cuff of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have been fixed in order to establish a basis for comparison. This test method for measuring can be used to compare tracheal tubes hav

49、ing differing types and designs of laser protection. 5.2 A large number and range of variables are involved in ignition of a tracheal tube cuff. A change in one variable may affect the outcome 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. BS EN ISO 11990-2:2014ISO 11990-2:2010(E) ISO 2010 All rights reserved 35.3 Since an oxygen-enriched atmosphere is often present in the clinical situation, either intentionall