Publication details
| Publication CODE |
Title |
| NBN EN 60601-1-2:2015 (2015-09) |
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
29.00 €
|
9 P.. |
Description
Applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards.
This fourth edition cancels and replaces the third edition, and constitutes a technical revision.
The most significant changes with respect to the previous edition include the following modifications:
- specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
- specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
- specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
- specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
- better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions:
- guidance for determination of immunity test levels for special environments;
- guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
- guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
- guidance on identification of immunity pass/fail criteria.
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| 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 60601-1-2:2014.
For the series NBN EN 50XXX, the standards are however complete.
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|
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Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 60601-1-2:2007
|
|
Origin
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-09-03 |
| NBN Approval |
2015-10-23 |
| Belgian Official Journal |
2015-11-08 |
| Registration |
159229 |
| Numbers identifying the european directives |
2004/108/EC
(Electromagnetic compatibility (Ex 89/336/EEC))
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.01
, 33.100.10
, 33.100.20
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2015-09-03 |
| Date of availability (d.a.v.) |
2015-09-18 |
| Date of announcement (d.o.a.) |
2015-12-18 |
| Date of publication (d.o.p.) |
2016-03-18 |
| Date of withdrawal former edition (d.o.w.) |
2018-12-31 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-1-2:2015
|
2015-09-18 |
| is identical to |
IEC 60601-1-2:2014/ed. 4.0
|
2014-02-25 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Foreign |
ISO 14971:2007 |
|
| Standard |
Foreign |
ISO 7137:1995 |
|
| Standard |
Foreign |
ISO 7637-2:2011 |
|
| Standard |
Belgium |
NBN EN 55011:2009 |
|
| Standard |
Belgium |
NBN EN 55014-1:2006 |
|
| Standard |
Belgium |
NBN EN 55016-1-2:2004 |
|
| Standard |
Belgium |
NBN EN 55032:2012 |
|
| Standard |
Belgium |
NBN EN 60601-1-11:2010 |
|
| Standard |
Belgium |
NBN EN 60601-1-12 |
|
| Standard |
Belgium |
NBN EN 60601-1-8:2007 |
|
| Standard |
Belgium |
NBN EN 60601-1:2006 |
|
| Standard |
Belgium |
NBN EN 60601-2-2:2009 |
|
| Standard |
Belgium |
NBN EN 60601-2-3:2015 |
|
| Standard |
Belgium |
NBN EN 61000-3-2:2006 |
|
| Standard |
Belgium |
NBN EN 61000-4-11:2004 |
|
| Standard |
Belgium |
NBN EN 61000-4-2:2009 |
|
| Standard |
Belgium |
NBN EN 61000-4-3:2006 |
|
| Standard |
Belgium |
NBN EN 61000-4-4:2012 |
|
| Standard |
Belgium |
NBN EN 61000-4-5:2006 |
|
| Standard |
Belgium |
NBN EN 61000-4-6:2014 |
|
| Standard |
Belgium |
NBN EN 61000-4-8:2010 |
|
| Standard |
Belgium |
NBN N 61000-3-3:2013 |
|
|
