Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-01-2023

Publisher

Comitato Elettrotecnico Italiano

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.

DocumentType	Standard
Pages	70
PublisherName	Comitato Elettrotecnico Italiano
Status	Current
Supersedes	CEI EN 60601-2-43 : 2011

Standards	Relationship
IEC 60601-2-43:2022	Identical
EN IEC 60601-2-43:2023	Identical

IEC 60601-1-10:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 60601-2-44:2009	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60601-1-11:2015	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-9:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-12:2014	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment