Account:  - Login  |  Webstore  |  Shopping basket cart
English  |  Français  |  Nederlands

Publication details

Publication CODE Title
NBN EN 60601-1-2:2015 (2015-09) MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
 
Price Excl. VAT Total number of pages, tables and drawings
29.00 € 9 P..
Description
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, 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.
Class  C
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

Very important notice: 98% of the text of the NBN EN 55XXX, NBN EN 6XXXX comes from the IEC text which is NOT included. This text can be ordered here: IEC 60601-1-2:2014. For the series NBN EN 50XXX, the standards are however complete.

EN version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Replaces  NBN EN 60601-1-2:2007
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-09-03
NBN Approval 2015-10-23
Belgian Official Journal 2015-11-08
Registration 159229
Numbers identifying the european directives 2004/108/EC  (Electromagnetic compatibility (Ex 89/336/EEC))
93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.01 , 33.100.10 , 33.100.20
NBN Status New
Date of ratification (d.o.r.) 2015-09-03
Date of availability (d.a.v.) 2015-09-18
Date of announcement (d.o.a.) 2015-12-18
Date of publication (d.o.p.) 2016-03-18
Date of withdrawal former edition (d.o.w.) 2018-12-31
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-1-2:2015 2015-09-18
is identical to IEC 60601-1-2:2014/ed. 4.0 2014-02-25
Relations to belgian/foreign publications
Type Origin Code Date
Standard Foreign ISO 14971:2007
Standard Foreign ISO 7137:1995
Standard Foreign ISO 7637-2:2011
Standard Belgium NBN EN 55011:2009
Standard Belgium NBN EN 55014-1:2006
Standard Belgium NBN EN 55016-1-2:2004
Standard Belgium NBN EN 55032:2012
Standard Belgium NBN EN 60601-1-11:2010
Standard Belgium NBN EN 60601-1-12
Standard Belgium NBN EN 60601-1-8:2007
Standard Belgium NBN EN 60601-1:2006
Standard Belgium NBN EN 60601-2-2:2009
Standard Belgium NBN EN 60601-2-3:2015
Standard Belgium NBN EN 61000-3-2:2006
Standard Belgium NBN EN 61000-4-11:2004
Standard Belgium NBN EN 61000-4-2:2009
Standard Belgium NBN EN 61000-4-3:2006
Standard Belgium NBN EN 61000-4-4:2012
Standard Belgium NBN EN 61000-4-5:2006
Standard Belgium NBN EN 61000-4-6:2014
Standard Belgium NBN EN 61000-4-8:2010
Standard Belgium NBN N 61000-3-3:2013