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Publication details

Publication CODE Title
NBN EN 60601-2-16:2015 (2015-06) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 4 P.
Description
Applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. Does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. Specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. Includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This edition cancels and replaces the previous edition. This edition constitutes a technical Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.
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 60601-2-16:2012. 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Situation Withdrawn
Replaced by  NBN EN IEC 60601-2-16:2019
Replaces  NBN EN 60601-2-16:1998
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-04-14
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158289
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.20 , 11.040.25
NBN Status New
Date of ratification (d.o.r.) 2015-04-14
Date of availability (d.a.v.) 2015-06-12
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.) 2018-04-14
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-2-16:2015 2015-06-12
is identical to IEC 60601-2-16:2012/ed. 4.0 2012-03-08