I.S. EN 60601-1-3:2008/A1:2013/AC:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medicalelectricalequipment --Part1-3: General requirements forbasicsafetyand essentialperformance- CollateralStandard: Radiationprotectionindiagnostic X-ray equipment
Hardcopy, PDF
09-01-2021
25-06-2014
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
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.