International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference EN 60601-1-3:2008/A1:2013
Title Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
Project Number 24481
Abstract/Scope This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2013-06-14
Current Stage code deadline 2014-02-24
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/TC 62
Reference Document IEC 60601-1-3:2008/A1:2013 (EQV)
ICS 11.040.50 - Radiographic equipment
13.280 - Radiation protection
Keywords Medical equipment; X-ray; Radiation protection; Diagnostic; Safety
Note 2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-05-02 - Publication editing allocated to aclausse@cencenelec.eu
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2013-06-14 2014-02-24 export to doc file  EN  FR  DE
5099 2013-05-24 2013-06-21  
5060 2013-01-21 2013-02-11 export to doc file  EN
5020 2012-10-12 2013-01-18  
1090 2012-10-09 2012-10-12  

Implementation Dates

date of Ratification (DOR) (1) 2013-05-24
date of Availability (DAV) (2) 2013-06-14
date of Announcement (DOA) (3) 2013-08-24
date of Publication (DOP) (4) 2014-02-24
date of Withdrawal (DOW) (5) 2018-12-31

Relations

Supersedes  
Superseded by  
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.