DIN EN ISO 11990-1-2016 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1 Tracheal tube shaft (ISO 11990-1 2011) German version EN I.pdf

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!%LFe“2413566w

2、ww.din.deDIN EN ISO 11990-1Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft (ISO 11990-1:2011);English version EN ISO 11990-1:2014,English translation of DIN EN ISO 11990-1:2016-02Laser und Laseranlagen Bestimmung der Laserresistenz v

3、on Trachealtuben Teil 1: Trachealtubusschaft (ISO 11990-1:2011);Englische Fassung EN ISO 11990-1:2014,Englische bersetzung von DIN EN ISO 11990-1:2016-02Lasers et quipements associs aux lasers Dtermination de la rsistance au laser des tubes trachaux Partie 1: Axe des tubes trachaux (ISO 11990-1:2011

4、);Version anglaise EN ISO 11990-1:2014,Traduction anglaise de DIN EN ISO 11990-1:2016-02SupersedesDIN EN ISO 11990-1:2011-11www.beuth.deDocument comprises 18 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.12 A comma is used

5、 as the decimal marker. National foreword This document (EN ISO 11990-1:2014) 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 “Lasers and photonics” (Secretariat: DIN, Ge

6、rmany). 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 Elektrotechnik Elektronik Informationstechni

7、k 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 tracheal tubes: Part 1: Tracheal tube shaft Pa

8、rt 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 11990-1:2011-11 as follows: a) the European foreword and Annex ZA have been a

9、mended. Previous editions DIN EN ISO 11990: 1999-11, 2003-10 DIN EN ISO 11990-1: 2011-11 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 propagation ratios Part 1: Stigmatic and simple

10、astigmatic beams DIN EN ISO 11990-1:2016-02 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11990-1 October 2014 ICS 11.040.10; 31.260 Supersedes EN ISO 11990-1:2011English Version Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal

11、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 trachaux (ISO 11990-1:2011) Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1: Trachealtubusschaft (ISO 11990-1:2

12、011) 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 and bibliographica

13、l 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 the responsibility o

14、f 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 Yugoslav Republic of Ma

15、cedonia, 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 DE NORMALISATION E

16、UROPISCHES 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 11990-1:2014 EContents Page European Foreword . 3 Annex ZA (informative) Relati

17、onship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC (Medical Devices) .5551 5555 Foreword .4 Introduction.5 1 Scope6 2 Normative references6 3 Terms and definitions .6 4 Principle7 5 Significance and use of the test 8 6 Apparatus.8 6.1 Gas supply system8 6.

18、2 Containment box .9 6.3 Smoke evacuation 10 6.4 Lasers and delivery systems.10 6.5 Oxygen analyser.11 7 Reagents and materials .11 8 Preparation of test specimen 11 9 Preparation of apparatus.11 10 Test procedure12 11 Interpretation of results .13 12 Test report.13 Bibliography.16DIN EN ISO 11990-1

19、:2016-02 EN ISO 11990-1:2014 (E) 25European 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) and has been taken over as EN ISO 11990-1:2014 by Technical Committee CEN/TC 123 “L

20、asers 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 latest by Apr

21、il 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 11990-1:2011. This document has been prepared

22、 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 Internal Regul

23、ations, 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, Ireland, It

24、aly, 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 11990-1:2011 has been approved by CEN as EN ISO 11990-1:2014 without any modification. DIN EN I

25、SO 11990-1:2016-02 EN ISO 11990-1:2014 (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 committees. Each memb

26、er 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 International Ele

27、ctrotechnical 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 Standards adop

28、ted 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 subject of pate

29、nt rights. ISO shall not be held responsible 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

30、 constitutes a minor revision. ISO 11990 consists 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 DIN EN ISO 11990-1:2016-02 EN ISO 11990-1:2014 (E) 4 Intro

31、duction A fire in the airway 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 lase

32、r are used bring together 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 followe

33、d by airway fires and, subsequently, 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

34、development of the test method 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. DIN EN ISO 11990-1:2016-02 EN ISO 11990-1:2014 (E) 5 1 Scope This part of ISO 11990 specifies a metho

35、d 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 other 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 meth

36、od 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 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

37、 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 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 applicabil

38、ity of the result of this test method to the clinical situation has not been fully established. CAUTION This test method can 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

39、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 determine the applicability of regulatory limitations prior to use. 2 Normative references The following referenced documents are indispensable for the a

40、pplication of this document. For dated references, 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

41、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-sectional area A95smallest area containing 95 % of the total beam power ISO 11990-2:2010 DIN EN ISO 11990-1:2016-02 EN

42、 ISO 11990-1:2014 (E) 6 3.2 beam diameter d95 diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % 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 c

43、hemical process of oxidation with the liberation of heat EXAMPLES Flame, smouldering, rapid evolution of smoke. ISO 11990-2:2010 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 L

44、ocal heating, melting, creation of holes, pyrolysis. ISO 11990-2:2010 3.5 ignition creation of combustion induced by the delivery 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

45、 of the tracheal tube between the cuff and the machine end of the tube 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 shaft of a tracheal tube is

46、 exposed to laser power of known characteristics while in an environment of (98 2) % oxygen. DIN EN ISO 11990-1:2016-02 EN ISO 11990-1:2014 (E) 7 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 sha

47、ft 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 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 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 establishe