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HD 395.2.7 : 200S1

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS

Superseded date

04-01-1998

Published date

01-12-2013

FOREWORD
PREFACE
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - SAFETY REQUIREMENTS
8 Basic safety categories
9 Removable protective means
10 Special environmental conditions
11 Special measures with respect to safety
12 SINGLE FAULT CONDITION
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
14 Requirements related to classification
15 Limitation of voltage and/or current
16 Enclosures and PROTECTIVE COVERS
17 Insulation and PROTECTIVE IMPEDANCES
18 Earthing and potential equalization
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
   CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability and transportability
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
               OR EXCESSIVE RADIATION
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other
   particle radiation
31 Microwave radiation
32 Light radiation (including visual radiation and lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultra-sonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF EXPLOSIONS IN
              MEDICALLY USED ROOMS
37 General
38 Classification, marking and ACCOMPANYING DOCUMENTS of
   ANAESTHETIC-PROOF EQUIPMENT
39 Common requirements for "AP" and "APG" EQUIPMENT
40 Requirements and tests for ANAESTHETIC-PROOF EQUIPMENT,
   EQUIPMENT parts or components (AP)
41 Requirements and tests for ANAESTHETIC-PROOF CATEGORY G
   EQUIPMENT, EQUIPMENT parts or components
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES,
                FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
   cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Materials in APPLIED PARTS in contact with the body of
   the PATIENT
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST INCORRECT OUTPUT
50 Accuracy of operating data
51 Protection against incorrect output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR
               MECHANICAL DAMAGE, ENVIRONMENTAL TESTS
52 Fault conditions causing overheating and/or mechanical
   damage
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 Enclosures and covers
56 Components and general assembly
57 MAINS PARTS, components and layout
58 PROTECTIVE EARTH TERMINALS
59 Construction and layout
Figures
Tables
APPENDIX AA - Values of the series R'10, ISO Standard 497
APPENDIX BB - Tables of combinations of LOADING FACTORS
              for tests
APPENDIX CC - Example for the determination of the combination
              of LOADING FACTORS according to sub-clause
              50.109 for tests for linearity and constancy
ALPHABETICAL INDEX

Applicable to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS that operate between 10 kV and 400 kV and in which the electric energy for LOADING an X-RAY TUBE is derived from alternating current SUPPLY MAINS without an essential element of energy storage within the equipment.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

Standards Relationship
VDE 0750-21 : 1989 Identical
IEC 60601-2-7:1998 Similar to
CEI 62-27 : 1ED 1997 Identical
UNE 20613-2-7:1993 Identical
I.S. HD 395-2-7:1990 Identical
NFC 74 112 : 1991 Identical

BS 5724-2.32(1995) : 1995 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ASSOCIATED EQUIPMENT FOR X-RAY EQUIPMENT
EN 61168 : 1994 Radiotherapy simulators - Functional performance characteristics
I.S. EN 61168:1994 RADIOTHERAPY SIMULATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
VDE 0750-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
BS EN 60601-2-32:1995 Medical electrical equipment. Particular requirements for safety Specification for associated equipment of X-ray equipment
DIN EN 60601-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
IEC 60637:1979 Marking of and accompanying documents for X-ray tubes and X-ray tube assemblies for medical use
ISO 3665:2011 Photography Intra-oral dental radiographic film and film packets Manufacturer specifications
ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers

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