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AS
AS/NZS 3200.2.28:1994

AS/NZS 3200.2.28:1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Approval and test specification - Medical electrical equipment Particular requirements for safety - X-ray source assemblies and X-ray tube assemblies for medical diagnosis generators

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

27-10-2017

Superseded by

AS/NZS IEC 60601.2.28:2015

Language(s)

English

Published date

19-09-1994

Publisher

Standards Australia

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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1 - AS/NZS 3200.2.28:1994 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-X-RAY SO
4 - PREFACE
6 - CONTENTS
8 - SECTION ONE - GENERAL
8 - 1 Scope and object
8 - 1.1 Scope
8 - 1.2 Object
8 - 1.3 Particular Standards
9 - 2 Terminology and definitions
9 - 4 General requirements for tests
10 - 5 Classification
10 - 6 Identification, marking and documents
15 - 7 Power input
15 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 16 Enclosures and protective covers
16 - 18 Protective earthing, functional earthing and potential equalization
16 - 19 Continuous leakage currents and patient currents
16 - 20 Dielectric strength
17 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
17 - 25 Expelled parts
17 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
17 - 29 X-Radiation
17 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
18 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
18 - 42 Excessive temperatures
19 - 45 Pressure vessels and parts subject to pressure
20 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
20 - 50 Accuracy of operating data
20 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
20 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
21 - Appendix L - References – Publications mentioned in this Standard
22 - Annex AA - Index of defined terms

Applies to X-ray source assemblies and X-ray tube assemblies for medical diagno sis and to components thereof, specified for use in medical X-ray equipment including equi pment for computed tomography incorporating a specified high voltage generator complying with AS/NZS 3200.2.7:1994 or AS/NZS 3200.2.15:1994. This Standard is to be read in c onjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-28:1 993.

Committee
HE-003
DocumentType
Standard
ISBN
0 7262 9139 0
Pages
16
PublisherName
Standards Australia
Status
Superseded
SupersededBy
UnderRevision

This Standard applies to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES formedical diagnosis, and to components thereof, specified for use in medical X-RAY EQUIPMENT including equipment for COMPUTED TOMOGRAPHY, that incorporates a specified HIGH-VOLTAGE GENERATOR complying with IEC 601-2-7 or IEC 601-2-15.

Standards Relationship
IEC 60601-2-28:1993 Identical

First published as a Joint Standard AS/NZS 3200.2.28:1994.

AS/NZS 3200.2.15:1994 Approval and test specification - Medical electrical equipment Particular requirements for safety - Capacitor discharge X-ray generators
AS/NZS 3200.2.7:1999 Medical electrical equipment Particular requirements for safety - High voltage generators of diagnostic X-ray generators

AS/NZS 60335.2.90:2006 Household and Similar Electrical Appliances - Safety Particular requirements for commercial microwave ovens
AS/NZS 60745.1:2009 Hand-held motor-operated electric tools-Safety General requirements (IEC 60745-1 Ed 4, MOD) (Reconfirmed 2020)
AS/NZS 3200.1.3:1996 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Requirements for radiation protection in diagnostic X-ray equipment
AS/NZS 3200.2.45:1999 Medical electrical equipment Particular requirements for safety - Mammographic X-ray equipment and mammographic stereotactic devices
AS 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities
AS/NZS 4274:1995 X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
AS/NZS 4184.3.2:1998 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of mammographic X-ray equipment

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