as nzs 4537-1999 medical electrical equipment - dosimeters with ionization chambers as used in...

7/31/2019 As NZS 4537-1999 Medical Electrical Equipment - Dosimeters With Ionization Chambers as Used in Radiotherapy

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AS/NZS 4537:1999IEC 60731:1997

Australian/New Zealand Standard

Medical electrical equipmentDosimeters with ionizationchambers as used in radiotherapy


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AS/NZS 4537:1999

This Joint Australian/New Zealand Standard was prepared by Joint TechnicalCommittee HE/3, Medical Electrical Equipment. It was approved on behalf of theCouncil of Standards Australia on 29 January 1999 and on behalf of the Council of Standards New Zealand on 18 January 1999. It was published on 5 March 1999.

The following interests are represented on Committee HE/3:

Australasian College of Physical Scientists and Engineers in MedicineAustralasian Society for Ultrasound in MedicineAustralian & New Zealand College of AnaesthetistsAustralian Chamber of Commerce and IndustryAustralian Dental AssociationAustralian Institute of RadiographyAustralian Radiation LaboratoryAustralian Society of AnaesthetistsCollege of Biomedical Engineering Institution of Engineers AustraliaCommonwealth Department of Health and Family ServicesDepartment of Defence (Australia)Health Industry Suppliers Association of New ZealandMedical Industry Association of AustraliaMinistry of Commerce, New ZealandRoyal Australasian College of SurgeonsRoyal Australasian College of PhysiciansRoyal Australasian College of Radiologists

Review of Standards. To keep abreast of progress in industry, Joint Australian/ New Zealand Standards are subject to periodic review and are kept up to date by the issueof amendments or new editions as necessary. It is important therefore that Standards usersensure that they are in possession of the latest edition, and any amendments thereto.Full details of all Joint Standards and related publications will be found in the StandardsAustralia and Standards New Zealand Catalogue of Publications; this information issupplemented each month by the magazines The Australian Standard and StandardsNew Zealand, which subscribing members receive, and which give details of newpublications, new editions and amendments, and of withdrawn Standards.Suggestions for improvements to Joint Standards, addressed to the head office of eitherStandards Australia or Standards New Zealand, are welcomed. Notication of anyinaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be madewithout delay in order that the matter may be investigated and appropriate action taken.

This Standard was issued in draft form for comment as DR 98300.


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AS/NZS 4537:1999

Australian/New Zealand Standard

Medical electrical equipmentDosimeters with ionizationchambers as used in radiotherapy

First published as AS/NZS 4537:1999.

Published jointly by:

Standards Australia1 The Crescent,Homebush NSW 2140 Australia

Standards New ZealandLevel 10, Radio New Zealand House,155 The Terrace,Wellington 6001 New Zealand

ISBN 0 7337 2536 8


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PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand CommitteeHE/3, Medical Electrical Equipment.This Standard is technically equivalent to and reproduced from IEC 60731:1997, Medical electricalequipmentDosimeters with ionization chambers as used in radiotherapy.

Appendix ZZ provides a variation to IEC 60731 for Australia and New Zealand. The change isindicated by a rule in the margin against the clause affected.

The even numbered pages of the original publication are in French and are omitted from thisversion. Some other pages of the original, which relate to IEC administrative matters, are alsoomitted from this version.

As this publication has been reproduced from an International Standard, the following modificationsapply:

(a) Its number does not appear on each page of text and its identity is shown on the cover andtitle page.

(b) The words this Australian/New Zealand Standard should replace the words this InternationalStandard wherever they appear.

(c) A full point should be substituted for a comma where the comma is being used as a decimalmarker.

The references to International Standards should be replaced by references to the followingAustralian or Joint Australian/New Zealand Standards:

Reference to International Standard Australian or New Zealand Standard

IEC60051 Direct acting indicating analogueelectrical measuring instruments andtheir accessories

AS

60417 Graphical symbols for use onequipmentIndex, survey andcompilation of the single sheets

1104 Informative symbols for use onelectrical and electronic equipment

60601 Medical electrical equipment60601-1 Part 1: General requirements for

safety

AS/NZS3200.1.0 Medical electrical equipment

Part 1.0: General requirements forsafety

Parent Standard60601-2-9 Part 2: Particular requirements for

the safety, of dosimeters used inradiotherapy with electrically-connected radiation detectors

60788 Medical radiologyTerminology

61000 Electromagnetic compatibility (EMC)61000-4-1 Part 4: Testing and measurement

techniquesSection 1: Overview of immunitytestsBasic EMC Publication


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IEC61000-4-2 Part 4: Testing and measurement

techniquesSection 2: Electrostatic

discharge requirementsBasicEMC Publication

AS

61000-4-3 Part 4: Testing and measurementtechniquesSection 3: Radiated electromagneticfield requirements

61000-4-4 Part 4: Testing and measurementtechniquesSection 4: Electrical fasttransient/burst requirementsBasic EMC Publication

61000-4-5 Part 4: Testing and measurementtechniquesSection 5: Surge immunityrequirements

61000-4-6 Part 4: Testing and measurementtechniquesSection 6: Conducted disturbancesinduced by radio frequency fieldsabove 9 kHz

61000-4-11 Part 4: Testing and measurementtechniquesSection 11: Voltage dips, shortinterruptions and voltage variationimmunity tests

61010 Safety requirements for electricalequipment for measurement control,and laboratory use

61010-1 Part 1: General requirements

61187 Electrical and electronic measuringequipmentDocumentation

ISO International vocabulary of basic andgeneral terms in metrology

3807 Vocabulary of basic and general termsin metrology

3534 StatisticsVocabulary andsymbols

3534-1 Part 1: Probability and generalstatistical terms

ICRU33 Radiation Quanti ties and Units

The terms normative and informative have been used in this Standard to define the application of the Annex or Appendix to which they apply. A normative Annex or Appendix is an integral partof a Standard, whereas an informative Annex is only for information and guidance.


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iv

Copyright STANDARDS AUSTRALIA/ STANDARDS NEW ZEALANDUsers of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software.Except where the Copyright Act allows and except where provided for below no publications or software produced byStandards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any meanswithout prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on anappropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed tothe head office of Standards Australia. New Zealand requests should be directed to Standards New Zealand.

Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of theStandard without payment of a royalty or advice to Standards Australia or Standards New Zealand.

Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programsare used exclusively in-house by the creators of the programs.

Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standardis amended or revised. The number and date of the Standard should therefore be clearly identified.

The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercialcontracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.


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