DIN EN ISO 11990-2-2016 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2 Tracheal tube cuffs (ISO 11990-2 2010) German version EN I.pdf

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1、February 2016 English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10; 31.260!%LFf“2413567w

2、ww.din.deDIN EN ISO 11990-2Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs (ISO 11990-2:2010);English version EN ISO 11990-2:2014,English translation of DIN EN ISO 11990-2:2016-02Laser und Laseranlagen Bestimmung der Laserresistenz v

3、on Trachealtuben Teil 2: Trachealtubusmanschetten (ISO 11990-2:2010);Englische Fassung EN ISO 11990-2:2014,Englische bersetzung von DIN EN ISO 11990-2:2016-02Lasers et quipements associs aux lasers Dtermination de la rsistance au laser des tubes trachaux Partie 2: Ballonnet de tubes trachaux (ISO 11

4、990-2:2010);Version anglaise EN ISO 11990-2:2014,Traduction anglaise de DIN EN ISO 11990-2:2016-02SupersedesDIN EN ISO 11990-2:2010-12www.beuth.deDocument comprises 19 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.02.16 DIN E

5、N ISO 11990-2:2016-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11990-2:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 9 “Electro-optical systems”, in close cooperation with Technical Committee CEN/TC 123 “Lase

6、rs and photonics” (Secretariat: DIN, Germany). The responsible German bodies involved in its preparation were DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee GAK 812.0.1 Laser in der Medizin, and the DKE Deutsche Kommission Elekt

7、rotechnik Elektronik Informationstechnik im DIN und VDE (German Commission for Electrical, Electronic and Information Technologies of DIN and VDE). DIN EN ISO 11990 consists of the following parts under the general title Lasers and laser-related equipment Determination of laser resistance of trachea

8、l tubes: Part 1: Tracheal tube shaft Part 2: Tracheal tube cuffs The DIN Standard corresponding to the International Standard referred to in Clause 2 of this standard is as follows: ISO 11146-1 DIN EN ISO 11146-1 Amendments This standard differs from DIN EN ISO 11990-2:2010-12 as follows: a) the Eur

9、opean foreword and Annex ZA have been amended. Previous editions DIN EN ISO 11990: 1999-11, 2003-10 DIN EN ISO 11990-2: 2010-12 National Annex NA (informative) Bibliography DIN EN ISO 11146-1, Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagati

10、on ratios Part 1: Stigmatic and simple astigmatic beams EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11990-2 October 2014 ICS 11.040.10; 31.260 Supersedes EN ISO 11990-2:2010English Version Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2:

11、 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 tubes trachaux (ISO 11990-2:2010) Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2: Trachealtubusmansche

12、tten(ISO 11990-2:2010) This European Standard was approved by CEN on 22 October 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists

13、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 Standard exists in three official versions (English, French, German). A version in any other language made by translation under th

14、e 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugos

15、lav 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN

16、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 means reserved worldwide for CEN national Members. Ref. No. EN ISO 11990-2:2014 EContents Page European foreword.3 Introduction.

17、5 1 Scope6 2 Normative references6 3 Terms and definitions .6 4 Principle7 5 Significance and use of the test 7 6 Apparatus.8 6.1 Gas supply system8 6.2 Containment box .9 6.3 Smoke evacuation device.12 6.4 Lasers and delivery systems12 6.5 Oxygen analyser12 7 Reagents and materials 13 8 Preparation

18、 of test specimens .13 9 Preparation of apparatus13 10 Test procedure.14 11 Interpretation of results 15 12 Test report15 Bibliography17 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC (Medical Devices) 1666 DIN EN ISO 11990

19、-2:2016-02 EN ISO 11990-2:2014 (E) 2Foreword .4 European 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 Standardization (ISO) and has been taken over as EN ISO 11990-2:2014 by Technical Committee

20、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 April 2015, and conflicting national standards shall be withdrawn at the

21、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 rights. This document supersedes EN ISO 11990-2:2010. This document has

22、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, which is an integral part of this document. According to the CEN-CENELEC I

23、nternal 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 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland

24、, 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 11990-2:2010 has been approved by CEN as EN ISO 11990-2:2014 without any modificat

25、ion. DIN EN ISO 11990-2:2016-02 EN ISO 11990-2:2014 (E) 3 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 committe

26、es. 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 Inte

27、rnational 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 International S

28、tandards 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. Attention is drawn to the possibility that some of the elements of this document may be the su

29、bject of patent rights. ISO shall not be 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 La

30、sers and laser-related equipment Determination of laser resistance of tracheal tubes: Part 1: Tracheal tube shafts Part 2: Tracheal tube cuffs DIN EN ISO 11990-2:2016-02 EN ISO 11990-2:2014 (E) 4 Introduction A fire in the airway is always a serious matter. In addition to local damage in the larynx,

31、 injury can occur to 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 ingredi

32、ents necessary to create 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 und

33、er a defined set of conditions. 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

34、contacted by the laser 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 trachea

35、l tube, such as the tip, which is normally unprotected. DIN EN ISO 11990-2:2016-02 EN ISO 11990-2:2014 (E) 5 1 Scope This part of ISO 11990 specifies 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

36、 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 The 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 desc

37、ribe the properties of materials, 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 me

38、thod 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 the 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

39、method to the clinical situation has not been fully established. NOTE 3 This test method might involve hazardous materials, 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 t

40、he responsibility of the user of this test method to establish appropriate safety and health practices and 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 r

41、eferences, only the edition cited applies. For undated references, the latest edition of the referenced document (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

42、 simple astigmatic beams 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 beam cross-sectional area A95smallest area containing 95 % of the total beam power DIN EN ISO 11990-2:2016-02 EN ISO 11990-2:2014 (E) 6 3.2 beam diameter d95diameter of

43、an aperture in a plane perpendicular to the beam axis which contains 95 % of the total beam power NOTE Adapted from ISO 11145:2006. 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

44、, smouldering, rapid evolution of smoke. 3.4 cuff inflatable balloon permanently attached around the tracheal tube near the 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 safet

45、y of the patient or efficacy of the tracheal tube due to increasing the risk of ignition EXAMPLE Local heating, melting, creation 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 pow

46、er without ignition or damage 4 Principle WARNING This test method can result in a rocket-like fire involving the tracheal 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 character

47、istics in an environment of 98 % 2 % oxygen. 5 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 cuff of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have been f

48、ixed in 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 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 situ