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 |
|
|
