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I.S. EN 60601-1-3:2008/A11:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Available format(s)

Hardcopy , PDF

Superseded date

24-03-2021

Language(s)

English - French

Published date

06-12-2016

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
ACCESSORIES
6 RADIATION management
7 RADIATION QUALITY
8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD
9 FOCAL SPOT TO SKIN DISTANCE
10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
11 Protection against RESIDUAL RADIATION
12 * Protection against LEAKAGE RADIATION
13 Protection against STRAY RADIATION
Annex A (informative) General guidance and rationale
Annex B (normative) Values of the series R'10 and R'20, ISO 497
Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1
Bibliography

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

Committee
TC 62
DocumentType
Standard
ISBN
978-2-83220-750-5
Pages
140
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO :IEC 60878
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 60601-1-3 : 2008 AMD 11 2016 Identical
IEC 60601-1-3:2008/AMD1:2013 Identical

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