as nzs iso 11990-2002 optics and optical instruments - lasers and laser-related equipment -...

7/31/2019 As NZS ISO 11990-2002 Optics and Optical Instruments - Lasers and Laser-related Equipment - Determination Of

1/8

AS/NZS ISO 11990: 2002ISO 11990:1999

Australian/New Zealand Standard

Optics and optical instrumentsLasersand laser-related equipmentDetermination of laser resistance oftracheal tube shafts

AS/NZS

ISO11990


2/8

AS/NZS ISO 11990: 2002

This Joint Australian/New Zealand Standard was prepared by Joint TechnicalCommittee HE-003, Medical Electrical Equipment. It was approved on behalf of theCouncil of Standards Australia on 26 June 2002 and on behalf of the Council ofStandards New Zealand on 20 June 2002. It was published on 28 June 2002.

The following are represented on Committee HE-003:

Australasian College of Physical Scientists and Engineers In MedicineAustralasian Society for Ultrasound in MedicineAustralian Chamber of Commerce and IndustryAustralian Dental AssociationAustralian Institute of RadiographyAustralian Radiation Protection and Nuclear Safety AgencyAustralian Society of Anaesthetists

Australian and New Zealand College of AnaesthetistsCanterbury District Health BoardCollege of Biomedical EngineeringInstitution of Engineers AustraliaCommonwealth Department of Health and AgeingDepartment of Defence (Australia)Health Industry Suppliers Association of New ZealandMasterton HospitalMedical Industry Association of Australia IncMinistry of Economic Development (New Zealand)Royal Australasian College of PhysiciansRoyal Australasian College of SurgeonsThe Royal Australian and New Zealand College of Radiologists

Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology andsystems. To maintain their currency, all Standards are periodically reviewed, andnew editions are published. Between editions, amendments may be issued.Standards may also be withdrawn. It is important that readers assure themselvesthey are using a current Standard, which should include any amendments whichmay have been published since the Standard was purchased.

Detailed information about joint Australian/New Zealand Standards can be found byvisiting the Standards Australia web site at www.standards.com.au or Standards

New Zealand web site at www.standards.co.nz and looking up the relevant Standard

in the on-line catalogue.Alternatively, both organizations publish an annual printed Catalogue with fulldetails of all current Standards. For more frequent listings or notification ofrevisions, amendments and withdrawals, Standards Australia and Standards NewZealand offer a number of update options. For information about these services,users should contact their respective national Standards organization.

We also welcome suggestions for improvement in our Standards, and especiallyencourage readers to notify us immediately of any apparent inaccuracies orambiguities. Please address your comments to the Chief Executive of eitherStandards Australia International or Standards New Zealand at the address shownon the back cover.

This Standard was issued in draft form for comment as DR 02153.
http://www.standards.com.au/http://www.standards.com.au/


3/8

AS/NZS ISO 11990: 2002

Australian/New Zealand Standard

Optics and optical instrumentsLasers

and laser-related equipment

Determination of laser resistance of

tracheal tube shafts

First published as AS/NZS ISO 11990:2002.

COPYRIGHT

Standards Australia/Standards New ZealandAll rights are reserved. No part of this work may be reproduced or copied in any form or by any

means, electronic or mechanical, including photocopying, without the written permission of thepublisher.

Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001and Standards New Zealand, Private Bag 2439, Wellington 6020

ISBN 0 7337 4677 2


4/8

ii

PREFACE

This Joint Australian/ New Zealand Standard has been developed to assist in the process of

implementation of the Australian Medical Device legislat ion.

After consultation with stakeholders in both countries, Standards Australia and Standards

New Zealand decided to develop this Standard as a Joint Australian/New Zealand Standard,

through the Joint Standards Australia/Standards New Zealand Committee HE-003 on

Medical Electrical Equipment.

This Standard is identical with and has been reproduced from ISO 11990:1999, Optics and

optical instruments Lasers and laser-related equipment Determination of laser

resistance of tracheal tube shafts.

The objective of this Standard is to specify a method of testing the laser resistance of the

shaft of a tracheal tube.

As this Standard is reproduced from an international Standard, the following applies:

(a) Its number does not appear on each page of text and its identity is shown only on thecover and title page.

(b) In the source text this International Standard' should read thisAustralian/New Zealand Standard.

(c) A full point substitutes for a comma when referring to a decimal marker.


5/8

iii

CONTENTS

1 Scope ........................................................................................................................................................................1

2 Normative reference................................................................................................................................................1

3 Terms anddefinitions .............................................................................................................................................14 Principle....................................................................................................................................................................2

5 Significance and use of the test.............................................................................................................................2

6 Apparatus .................................................................................................................................................................3

7 Reagents and materials...........................................................................................................................................5

8 Preparation of test units .........................................................................................................................................6

9 Preparation of apparatus ........................................................................................................................................6

10 Test procedure.......................................................................................................................................................6

11 Interpretation of results ........................................................................................................................................7

12 Test report ..............................................................................................................................................................8

Bibliography................................................................................................................................................................9


6/8

iv

INTRODUCTION

Surgery in the airway in which a laser is used brings together an oxygen-enriched atmosphere, fuel, and high

energy that can combine to create a fire. In the early to middle 1980s, the increasing use of such lasers wasfollowed by airway fires and the subsequent development of tracheal tubes designed specifically to be resistant tolaser ignition and damage. Unfortunately, some of these tubes were not sufficiently resistant under operating roomconditions, and airway fires continued to occur. These events lead to the development of the test method describedin this International Standard, in order to assist the clinician in determining which tracheal tube shaft is most laser-resistant for a defined set of conditions.


7/8

AUSTRALIAN/NEW ZEALAND STANDARD

Optics and optical instrumentsLasers and laser-relatedequipmentDetermination of laser resistance of tracheal tubeshafts

1 Scope

This International Standard specifies a method of testing the laser resistance of the shaft of a tracheal tube. Othercomponents of the system, such as the inflation system and cuff, are outside the scope of this InternationalStandard. The specified test method should be used to measure and describe the properties of materials, productsor assemblies in response to heat and flame under controlled laboratory conditions and should not be used to

describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions.However, results of this test may be used as elements of a fire risk assessment which takes into account all of thefactors which are pertinent to an assessment of the hazard of a particular end use.

NOTE 1 Caution should be observed in interpreting these results, since the direct applicability of the result of this testmethod to the clinical situation has not been fully established.

NOTE 2 This test method may involve hazardous materials, operations, and equipment. This International Standard does notpurport to address all of the safety problems associated with its use. It is the responsibility of the user of this test method toestablish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2 Normative reference

The following normative document contains provisions which, through reference in this text, constitute provisions ofthis International Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent edition of the normative document indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.

ISO 11146: 1999, Lasers and laser-related equipment Test methods for laser beam parameters Beam widths,divergence angle and beam propagation factor.

3 Terms anddefinitionsFor the purposes of this International Standard, the following terms and definitions apply.

3.1laser resistance

measure of the ability of a material to withstand laser power without burning or damage

3.2burning

chemical process of oxidation with the liberation of heat

1

COPYRIGHT


8/8

This is a free preview. Purchase the entire publication at the link below:

Looking for additional Standards? Visit SAI Global Infostore

Subscribe to ourFree Newsletters about Australian Standards in Legislation; ISO, IEC, BSI and more

Do you need to Manage Standards Collections Online?

Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation

Do you want to know when a Standard has changed?

Want to become an SAI Global Standards Sales Affiliate?

Learn about other SAI Global Services:

LOGICOM Military Parts and Supplier DatabaseMetals Infobase Database of Metal Grades, Standards and Manufacturers

Materials Infobase Database of Materials, Standards and Suppliers

Database of European Law, CELEX and Court Decisions

Need to speak with a Customer Service Representative - Contact Us

AS/NZS ISO 11990:2002, Optics and opticalinstruments - Lasers and laser-related equipment -Determination of laser resistance of tracheal tubeshafts
http://infostore.saiglobal.com/store?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Newsletters/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Collections/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/StandardsWatch/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Affiliate/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Metals/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Materials/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/European-Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/getpage.aspx?path=/InformationServices/shop/pages/ContactingUs.htm&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/Details.aspx?ProductId=393235&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/getpage.aspx?path=/InformationServices/shop/pages/ContactingUs.htm&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/European-Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Materials/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Metals/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Affiliate/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/StandardsWatch/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Collections/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Newsletters/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSites

as nzs iso 11990-2002 optics and optical instruments - lasers and laser-related equipment -...

Documents