| 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 |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 60601-1-11:2010
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| 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 |
|
