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

 

Project

Reference EN 60601-1-2:201X
Title Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Project Number 24111
Abstract/Scope IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; - specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; - specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; - specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and - better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term 'life-supporting'. This new edition includes the following main additions: - guidance for determination of immunity test levels for special environments; - guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; - guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and - guidance on identification of immunity pass/fail criteria.
Status
Approved

Status

Current Stage code 5099
Current Stage code date 2014-04-01
Current Stage code deadline 2014-04-29
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC), EMC related (2004/108/EC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-2:2014 (EQV)
ICS 11.040.01 - Medical equipment in general
33.100.10 - Emission
33.100.20 - Immunity
Keywords Medical equipment; Perturbation; Electromagnetic; Test; Safety
Note 2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 Will supersede EN 60601-1-2:2007 + corr. Mar.2010
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5099 2014-04-01 2014-04-29  
5060 2014-02-03 2014-02-24 export to doc file  EN
5020 2013-11-29 2014-01-31  
3090 2013-11-26 2013-11-29  
5060 2012-08-20 2012-09-10 export to doc file  EN
5020 2012-03-23 2012-08-17  
1090 2012-03-13 2012-03-16  

Implementation Dates

date of Ratification (DOR) (1) 2014-04-01
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) 2014-07-01
date of Publication (DOP) (4) 2015-01-01
date of Withdrawal (DOW) (5) 2017-04-01

Relations

Supersedes EN 60601-1-2:2007
EN 60601-1-2:2007/corrigendum Mar. 2010
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.