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.
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EN version
|
DE version
|
FR version
|
|
Status
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 |
|
