BS EN 61326-2-6:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment
Hardcopy , PDF
08-06-2021
English
31-07-2013
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1 Scope
2 Normative references
3 Terms and definitions
4 General
5 EMC test plan
6 Immunity requirements
7 Emission requirements
8 Test results and test report
9 Instructions for use
Annex A (normative) - Immunity test requirements
for portable test and measurement equipment
powered by battery or from the circuit being
measured
Bibliography
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Describes minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.
| Committee |
GEL/65/1
|
| DevelopmentNote |
To be read in conjunction with BS EN 61326-1. Supersedes 04/30116660 DC. (06/2006) Together with BS EN 61326-1, BS EN 61326-2-1, BS EN 61326-2-2, BS EN 61326-2-3, BS EN 61326-2-4, BS EN 61326-2-5, BS EN 61326-3-1 and BS EN 61326-3-2, supersedes BS EN 61326. (01/2009) Supersedes 10/30216029 DC. (07/2013)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012.
This publication is to be read in conjunction with IEC 61326-1:2012.
| Standards | Relationship |
| DIN EN 61326-2-6 : 2013 | Identical |
| IEC 61326-2-6:2012 | Identical |
| NF EN 61326-2-6 : 2013 | Identical |
| UNE-EN 61326-2-6:2006 | Identical |
| EN 61326-2-6:2013 | Identical |
| NBN EN 61326-2-6 : 2013 | Identical |
| SN EN 61326-2-6 : 2006 | Identical |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| IEEE/ANSI C63.18-2014 | American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| EN 61326-1:2013 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
| AAMI TIR18:2010 | GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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