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Publication details

Publication CODE Title
NBN EN 60601-1-12:2015 (2015-05) 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
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 6 P.
Description
Constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular 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 60601-1-12:2014. 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
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2014-07-24
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158283
Numbers identifying the european directives 90/385/EEC  (Active implantable medical devices)
93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040
NBN Status New
Date of ratification (d.o.r.) 2014-07-24
Date of availability (d.a.v.) 2015-05-22
Date of announcement (d.o.a.) 2015-08-22
Date of publication (d.o.p.) 2015-11-22
Date of withdrawal former edition (d.o.w.) 2018-12-31
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-1-12:2015 2015-05-22
is identical to IEC 60601-1-12:2014/ed. 1.0 2014-06-19
Relations to belgian/foreign publications
Type Origin Code Date
Standard Foreign ISO 7000:2014
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 60601-1-11:2015
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 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