AS/NZS 3200.2.

15:1994
IEC 601-2-15:1988

Australian/New Zealand Standard

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Approval and test specification—

Medical electrical equipment

Part 2.15: Particular requirements

for safety—Capacitor discharge
X-ray generators
[IEC title: Medical electrical equipment, Part 2: Particular
requirements for the safety of capacitor discharge X-ray generators]
 AS/NZS 3200.2.15:1994

This Joint Australian/New Zealand Standard was prepared by Joint Technical

Committee HT/23, Medical Diagnostic Imaging Equipment. It was approved on behalf
of the Council of Standards Australia on 26 May 1994 and on behalf of the Council
of Standards New Zealand on 27 June 1994. It was published on 22 August 1994.

The following interests are represented on Committee HT/23:

Australian Academy of Dento-Maxillo-Facial Radiologists

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Australian and New Zealand Society of Nuclear Medicine

Australian Chamber of Commerce and Industry
Australian College of Physical Scientists and Engineers in Medicine
Australian Dental Association
Australian Institute of Radiography
Australian Radiation Laboratory
Department of Defence, Australia
Environment Protection Authority, N.S.W.
Health Department, W.A.
Ministry of Commerce, New Zealand
Public Works Department, N.S.W.
Queensland Health
Radiation Health Standing Committee
Royal Australasian College of Radiologists
South Australian Health Commission
United Dental Hospital, Sydney
University of Sydney
University of Waikato, New Zealand

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 issue
of amendments or new editions as necessary. It is important therefore that Standards
users ensure 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
Standards Australia and Standards New Zealand Catalogue of Publications; this
information is supplemented each month by the magazines ‘The Australian Standard’
and ‘Standards New Zealand’, which subscribing members receive, and which give
details of new publications, new editions and amendments, and of withdrawn
Standards.
Suggestions for improvements to Joint Standards, addressed to the head office of either
Standards Australia or Standards New Zealand, are welcomed. Notification of any
inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be
made without delay in order that the matter may be investigated and appropriate action
taken.
 AS/NZS 3200.2.15:1994

Australian/New Zealand Standard

This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Approval and test specification—

Medical electrical equipment

Part 2.15: Particular requirements

for safety—Capacitor discharge
X-ray generators

First publi shed as Joint Standard AS/NZS

3200.2.15:1994.

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA
1 The Crescent,
Homebush NSW 2140 Australia

STANDARDS NEW ZEALAND

Level 10, Standards House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7262 9046 7
 ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HT/23
on Medical Diagnostic Imaging Equipment as a Joint Standard under the terms of the Active
Cooperation Agreement between Standards Australia and Standards New Zealand.

This Standard is identical with and has been reproduced from IEC 601-2-15:1988, Medical electrical
equipment Part 2: Particular requirements for safety — Capacitor discharge X-ray generators .

This Standard is one of a series of Approval and Test Specifications issued by Standards Australia and
Standards New Zealand for various categories of medical equipment. It is supplementary to AS/NZS
3200.1:1990, Approval and test specification —Medical electrical equipment , Part 1: General
requirements for safety.

The international Standard IEC 601-2-15 modifies and supplements the corresponding Clauses of
IEC 601-1:1988, Medical electrical equipment, Part 1: General requirements for safety which has been
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adopted as AS/NZS 3200.1, hereinafter referred to as the General Standard. The requirements of a
Particular Standard take priority, where appropriate, over those of the General Standard.

In the text of this Standard, the following print types are used:

(i) Requirements, compliance with which can be tested and definitions . . in large roman type

(ii) Explanations, advice, introductions, general statements,

exceptions and references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . in smaller roman type

(iii) Headings of sub-clauses and text specifications . . . . . . . . . . . . . . . . . . . . . in italic type

(iv) Terms used throughout the Standard, which have been defined in
Clause 2 and which are also in the index . . . . . . . . . . . . . . . . . . . . . . IN SMALL CAPITALS

Under arrangements made between Standards Australia/Standards New Zealand and ISO/IEC, as well
as certain other Standards organizations, users of this Standard are advised that the number of this
Standard is not reproduced on each page; its identity is shown only on the cover and title page.

For the purpose of this Standard, the IEC text should be modified as follows:

(a) Terminology The words ‘this Australian/New Zealand Standard’ should replace the words ‘this
International Standard’ wherever they appear.

(b) Decimal marker Substitute a full point for a comma where it appears as a decimal marker.

 Copyri ght STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND

Users of Standards are reminded that copyri ght subsists in all Standards Austr alia and Standards New Zealand publications and
soft ware. Except where the Copyri ght Act allows and except where provided for below no publi cati ons or software produced by
Standards Australi a or Standards New Zealand may be reproduced, stored in a retr ieval system in any form or tr ansmit ted by any
means wit hout prior permission in writ ing from Standards Austr alia or Standards New Zealand. Permission may be conditi onal on an
appropri ate royalty payment. Australi an requests for permission and informati on on commercial soft ware royalti es should be directed
to the head offi ce of Standards Austr alia. 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 the Standard without payment of a royalt y or advice to Standards Australi a or Standards New Zealand.
Inclusion of copyri ght materi al in computer soft ware programs is also permitt ed wit hout royalt y payment provided such
programs are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that materi al used is fr om the current editi on of the Standard and that it is updated whenever the
Standard is amended or revised. The number and date of the Standard should therefore be clearly identif ied.
The use of material in pri nt form or in computer soft ware programs to be used commercially, with or without payment, or in
commercial contracts is subject to the payment of a royalt y. This poli cy may be varied by Standards Austr alia or Standards New
Zealand at any ti me.
 iii

CONTENTS

SECTION O NE — GENER AL

Clause Page
1. Scope and object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Part icular Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.4 Environmental conditi ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. Terminology and defi niti ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.12 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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3. General requir ements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3.101 Conventi onal meanings of electr ical quanti ti es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.102 Radiation quanti ti es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4. General requir ements for tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Type tests and routi ne tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.10 Moisture pre-conditi oning tr eatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Classif ication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6. Identif ication, marking and documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1 Marking on the outside of equipment or equipment part s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.2 Marking on the inside of equipment or equipment part s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.7 Indicator lights and push butt ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.8 ACCOM PANYING D OC UME NTS .. .. .... .. .. ... ... ...... ... .... .. ...... ... ... ... ..... .. .. ... .. .. 7
7. Power input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

SECTION T WO — SA FETY R EQU IREMENTS

8. Basic safety categori es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9. Removable protective means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10. Special envir onmental conditi ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11. Special measures with respect to safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12. SINGL E FAULT CON DITION .. .. .... .. .. ... ... ...... ... .... .. ...... ... ... ... ..... .. .. ... .. .. .... .. . 10

SECTION T HR EE — PROTECTION A GAINST E LECTRIC SH OC K H AZARD S

13. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
14. Requir ements related to classifi cati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
15. Limitati on of voltage and/or curr ent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
16. Enclosures and PROTECTIVE COV ERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
17. Insulati on and PROT ECTIVE IMPEDAN CES .. .. .... .. .. ... ... ...... ... .... .. ...... ... ... ... ..... .. .. ... . 12
18. Eart hing and potential equali zati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
19. Continuous LEAK AG E CUR REN TS and PATIENT AU XILIARY CURR ENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
19.3 All owable values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
20. Dielectr ic strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
20.3 Values of test voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
20.4 Tests .. .. .... .. .. ... ... ...... ... .... .. ...... ... ... ... ..... .. .. ... .. .. .... .. ....... ... . .. 13

SECTION F OU R — PROTECTION A GAINST M ECH AN ICAL HA ZARDS

21. Mechanical str ength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
22. Moving part s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
 iv

Clause Page
23. Surf aces, corners and edges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
24. Stabil it y and transport abil it y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
25. Expell ed parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

26. Vibration and noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

27. Pneumati c and hydraulic power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
28. Suspended masses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

SECTION F IVE — PROTECTION AG AINST HA ZAR DS FROM UN WA NTED OR EXCESSIVE RAD IATION
29. X-radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

29.1 X-RADIATION generated by diagnostic CAPA CITOR DISCHARG E X-RAY G ENERAT OR S . . . . . . . . . . . . . . . . . . . . . . . . . . 15

30. Alpha, beta, gamma, neutron radiati on and other part icle radiati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
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31. Microwave radiati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

32. Light radiati on (i ncluding visual radiati on and lasers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

33. Infr a-red radiati on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

34. Ultr a-violet radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
35. Acoustical energy (including ult rasonics) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
36. Electr omagneti c compatibil it y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

SECTION SIX — PROTECTION AGAINST HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS

37. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
38. Classifi cati on, marking and ACC OMPAN YING DO CUM ENTS of A NAE STHETIC- PROOF EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . 18
39. Common requirements for “AP” and “APG” equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

40. Requir ements and tests for A NAE STHETIC -PROOF EQUIPMENT , equipment parts or components (AP) . . . . . . . . . . . . . . . . . . . . . 18
41. Requir ements and tests for A NAE STHETIC -PROOF CA TEGOR Y G EQUIPMENT , equipment part s or components . . . . . . . . . . . . . . . 18

SECTION S EVEN — PROTECTION AG AINST EXCESSIVE TEMPERA TUR ES, FIRE AN D OTH ER HAZ ARD S,
SUCH A S HU MAN ERROR S

42. Excessive temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

42.1 Addit ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
42.5 Guards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
43. Fire preventi on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
44. Overfl ow, spill age, leakage, humidit y, ingress of li quids, cleaning, steri li zati on and disinfection . . . . . . . . . . . . . . . . . . . . . . 19
45. Pressure vessels and parts subject to pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

46. Human err ors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

47. Electr ostati c charges .. .. .... .. .. ... ... ...... ... .... .. ...... ... ... ... ..... .. .. ... .. .. .... .. ..... 19
48. Materi als in APPLIED PART S in contact wit h the body of the PATIENT .. .. .... .. .. ... ... ...... ... .... .. ...... .. 19
49. Interr upti on of the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

SECTION E IGHT — ACCUR AC Y OF O PERATING DA TA A ND PROTECTION A GAINST INCO RRECT OUT PUT

50. Accuracy of operating data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

50.1 Indicati on of electri c and radiati on output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
50.101 through 50.103 — REQUIREMEN TS O N OPERA TIONA L D ATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
50.101 Reproducibil it y of radiation output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
50.102 Agreement between indicated and measured values of LOA DING FACTO RS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
50.103 Corr ecti on for fluctuati ons of MA INS VOL TAG E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
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Clause Page

50.104 to 50.107 — GENERAL REQUIREMENTS ON COMPLIANC E TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

50.104 Test condit ions . . . . . . . . . . . . . . . . . . ...... ... .... .. . ..... ... . .. ... . .... .. .. . .. .. .. .... .. . .. 22
50.105 General . . . . . . . . . . . . . . . . . . . . . . . . ... .... .. ...... . .. ... ... . .... .. .. ... .. .. .... .. ....... .. 23
50.106 Methods of measuri ng LOAD ING FACTOR S .. .. .... .. .. .. . ... .. .... ... ... . .. ...... ... ... ... .... . . 24
50.107 Condit ions for measuring AIR K ERMA . . .. .... .. .. ... .. . ..... . ... .... .. ...... ... ... ... ..... .. .. 24
50.108 and 50.109 — PRESELECTED LOA DING FACTORS FOR TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
50.108 Combination of loading factors for the determinati on of COEFFICIENT O F VAR IATION . . . . . . . . . . . . . . . . . . . . . . . . . 26
50.109 Combination of LOA DING FACTORS for the determinati on of PER CENT AV ERAGE ERRO R . . . . . . . . . . . . . . . . . . . . . . . 26
51 Protecti on against incorr ect output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

SECTION N INE — FA ULT COND ITION S CAUS ING OV ERH EATING A ND /OR MECHAN ICAL DA MAG E;
ENVIRONM ENTAL TESTS

52. Fault conditi ons causing overheati ng and/or mechanical damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

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53. Environmental tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

SECTION T EN — CO NSTRU CTIONA L REQUIREMEN TS

54. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

55. Enclosures and covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

56. Components and general assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
56.8 Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
56.11 Swit ches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
57. MAINS PART S , components and layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
57.1 Separati on from the SUPPLY MAINS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
57.9 Mains supply transformers and MEDICAL ISOLATING TRAN SFORMERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
57.10 CREEPAG E DISTAN CES and A IR CLEAR AN CES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
58. PROTECTIVE EAR TH TERMINALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
59. Constr ucti on and layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

59.4 Oil containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

FIGU RE 101 — TO TAL FILTRAT ION for the measurement of AIR K ERMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

TA BLE 101 — Permissible PER CEN T AVE RAG E ERROR of LOA DING FACTO RS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

(PAGE VI IN THE HARD COPY IS BLANK)

 1

AUSTRALIAN/NEW ZEALAND STANDARD

Approval and test specification— Medical electrical equipment

Part 2.15:
Particular requirements for safety — Capacitor discharge X-ray generators

SECTION ONE — GENERAL

1. Scope and object

This clause of the General Standard applies, except as follows:

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1.1 Scope

Addition:

This Particular Standard applies to CAPACITOR DISCHARGE X- RAY GENERATORS operating in

INTERMITTENT MODE for medical RADIOGRAPHY, in which the electrical energy for LOADING of the X -RAY
TUBE is completely or mainly capacitively stored at, and switched in, the high-voltage circuit.

This Particular Standard is confined to those devices which are MEDICAL ELECTRICAL EQUIPMENT and
in which

— the storage capacitor is in the high-voltage circuit and has a specified capacitance not exceeding 2 µF,

— the INITIAL X- RAY TUBE VOLTAGE is between 40 kV and 150 kV,

— an overcurrent protection, if provided, would not require a rating exceeding that which corresponds
to an apparent power of 3 kVA,

— LOADING of the X-RAY TUBE is controlled in the high-voltage circuit.

This Particular Standard does not exclude CAPACITOR DISCHARGE X- RAY GENERATORS that are capable
of operation in CONTINUOUS MODE for DIRECT RADIOSCOPY or INDIRECT RADIOSCOPY . However, for this
mode of operation the device will have to comply with the relevant requirements for diagnostic HIGH -
VOLTAGE GENERATORS and diagnostic X- RAY EQUIPMENT (see Sub-clause 1.3.102).

1.2 Object

Replacement:

The object of this Particular Standard is to establish particular requirements to ensure safety and to
specify methods for demonstrating compliance with those requirements.

Requir ements for reproducibil it y and accuracy are given because of their relationship to the qualit y and quanti ty of the IONIZING
RA DIATIONproduced and are confined to those considered necessary for safety.

Rati onale. — Both the levels for compliance and the tests prescri bed to determine compli ance reflect the fact that the safety of
CA PACITOR D ISCHAR GE X- RAY GENER ATORS is not sensit ive to small dif ferences in levels of performance. The combinati ons of
LOADING FACTO RS specifi ed for the tests are therefore limit ed in number but are chosen from experi ence as being appropriate in most
cases. It is considered important to standardize the choice of combinati ons of LOA DING FAC TOR S so that comparison can be made
between tests performed in dif ferent places on dif ferent occasions. However, combinati ons other than those specifi ed could be of equal
technical validit y.

COPYRIGHT
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AS/NZS 3200.2.15:1994, Approval and test

specification - Medical electrical equipment
Particular requirements for safety - Capacitor
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

discharge X-ray generators

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