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Publication details

Publication CODE Title
NBN EN 60601-1-11:2015 (2015-05) 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
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 6 P..
Description
Applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.
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 60601-1-11:2015. For the series NBN EN 50XXX, the standards are however complete.

EN version
DE version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Replaces  NBN EN 60601-1-11:2010
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-04-14
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158282
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.01 , 11.020.10
NBN Status New
Date of ratification (d.o.r.) 2015-04-14
Date of availability (d.a.v.) 2015-05-22
Date of announcement (d.o.a.) 2015-07-14
Date of publication (d.o.p.) 2016-01-14
Date of withdrawal former edition (d.o.w.) 2018-12-31
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-1-11:2015 2015-05-22
is identical to IEC 60601-1-11:2015/ed. 2.0 2015-01-20
Relations to belgian/foreign publications
Type Origin Code Date
Standard Foreign ISO 7000
Standard Belgium NBN C 20-529
Standard Belgium NBN EN 55011:2009
Standard Belgium NBN EN 60068-2-27:2009
Standard Belgium NBN EN 60068-2-31:2008
Standard Belgium NBN EN 60068-2-64:2008
Standard Belgium NBN EN 60601-1-12:2015
Standard Belgium NBN EN 60601-1-2:2014
Standard Belgium NBN EN 60601-1-6:2010
Standard Belgium NBN EN 60601-1-6:2010/A1:2015
Standard Belgium NBN EN 60601-1-8:2007
Standard Belgium NBN EN 60601-1-8:2007/A1:2013
Standard Belgium NBN EN 60601-1:2006
Standard Belgium NBN EN 60601-1:2006/A1:2013
Standard Belgium NBN EN 62366:2008
Standard Belgium NBN EN 62366:2008/A1:2015
Standard Belgium NBN EN ISO 15223-1:2012
Standard Belgium NBN EN ISO 7010:2012
Standard Belgium NBN EN ISO 7010:2012/A1:2014
Standard Belgium NBN EN ISO 7010:2012/A2:2014
Standard Belgium NBN EN ISO 7010:2012/A3:2014
Standard Belgium NBN EN ISO 7010:2012/A4:2014
Standard Belgium NBN EN ISO 7010:2012/A5:2015