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I.S. EN 60601-1-3:2008/A2:2021

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008/A2:2021)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

23-03-2021

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
6 RADIATION management
7 RADIATION QUALITY
8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD and IMAGE RECEPTION AREA
9 FOCAL SPOT TO SKIN DISTANCE
10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR
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
Index of defined terms used in this collateral standard

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
978-2-8322-9330-0
Pages
156
ProductNote
This standard is also refer as CEI 60336, CEI 60522, CEI 60601-1, CEI 60788, IEC 60878, IEC/TR 60788:2004 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
IEC 60601-1-3:2008/AMD2:2021 Identical
EN 60601-1-3:2008/A2:2021 Identical

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