Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

IEC 61746-1:2009(E) provides procedures for calibrating single-mode optical time domain reflectometers (OTDR). It only covers OTDR measurement errors and uncertainties. This standard does not cover correction of the OTDR response. This first edition of IEC 61746-1 cancels and replaces the second edition of IEC 61746, published in 2005. It constitutes a technical revision. The main technical changes are the adaptation of Clause 4, the suppression of Clause 10, the improvement and the addition of some definitions, the change of some calculations and the change of graphical symbology to IEC/TR 61930.

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003)

Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen Dienstleistungen darzulegen hat, die ständig die Anforderungen der Kunden und die für Medizinprodukte und zugehörige Dienstleistungen zutreffenden gesetzlichen Anforderungen erfüllen.
Das primäre Ziel dieser Internationalen Norm ist die Ermöglichung der Harmonisierung der für Medizinprodukte zutreffenden gesetzlichen Anforderungen an Qualitätsmanagementsysteme. Im Ergebnis dessen enthält sie einige besondere Anforderungen an Medizinprodukte und schließt einige Anforderungen von ISO 9001 aus, die nicht als Anforderungen für gesetzliche Zwecke geeignet sind. Wegen dieser Ausschlüsse können Organisationen, deren Qualitätsmanagementsysteme dieser Internationalen Norm entsprechen, keine Konformität mit ISO 9001 beanspruchen, außer wenn ihr Qualitätsmanagementsystem mit allen Anforderungen von ISO 9001 konform ist (siehe Anhang B).

Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003)

L'IEC 61746-1:2009 fournit des procédures destinées à l'étalonnage des réflectomètres optiques dans le domaine de temps pour fibres unimodales (OTDR). Elle ne traite que des erreurs de mesure et incertitudes de l'OTDR. Cette norme ne couvre pas la correction de la réponse de l'OTDR. Cette première édition de la CEI 61746-1 annule et remplace la deuxième édition de la CEI 61746, publiée en 2005. Elle constitue une révision technique. Les principales modifications techniques sont l'adaptation de l'article 4, la suppression de l'article 10, l'amélioration et l'ajout de certaines définitions, le changement de certains calculs et le changement de symbologie graphique IEC / TR 61930. Mots clés : l'étalonnage des réflectomètres optiques dans le domaine de temps pour fibres unimodales (OTDR)

Kalibriranje optičnih reflektometrov v časovnem prostoru (OTDR) - 1. del: OTDR za enorodna vlakna (IEC 61746-1:2009)

Ta del IEC 61746 podaja postopke kalibriranja enorodovnih optičnih časovnih reflektometrov (OTDR). Zajema le napake merjenja in negotovosti za OTDR. Ta standard ne zajema popravka odziva OTDR.

General Information

Status
Published
Publication Date
03-Mar-2011
Technical Committee
Drafting Committee
Parallel Committee
Current Stage
6060 - Document made available - Publishing
Completion Date
04-Mar-2011

Relations

Standard
EN 61746-1:2011
English language
93 pages
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Standards Content (Sample)


SLOVENSKI STANDARD
01-maj-2011
1DGRPHãþD
SIST EN 61746:2005
.DOLEULUDQMHRSWLþQLKUHIOHNWRPHWURYYþDVRYQHPSURVWRUX 27'5 GHO27'5]D
HQRURGQDYODNQD ,(&
Calibration of Optical Time-Domain Reflectometers (OTDR) - Part 1: OTDR for single-
mode fibres (IEC 61746-1:2009)
Kalibrierung optischer Rückstreumessgeräte (OTDR) - Teil 1: OTDR für Einmodenfasern
(IEC 61746-1:2009)
Étalonnage des réflectomètres optiques dans le domaine temporel (OTDR) - Partie 1:
OTDR pour fibres unimodales (CEI 61746-1:2009)
Ta slovenski standard je istoveten z: EN 61746-1:2011
ICS:
17.180.30 2SWLþQLPHULOQLLQVWUXPHQWL Optical measuring
instruments
33.180.99 'UXJDRSUHPD]DRSWLþQD Other fibre optic equipment
YODNQD
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61746-1
NORME EUROPÉENNE
March 2011
EUROPÄISCHE NORM
ICS 33.180.01 Supersedes EN 61746:2005 (partially)

English version
Calibration of optical time-domain reflectometers (OTDR) -
Part 1: OTDR for single-mode fibres
(IEC 61746-1:2009)
Étalonnage des réflectomètres optiques Kalibrierung optischer
dans le domaine temporel (OTDR) - Rückstreumessgeräte (OTDR) -
Partie 1: OTDR pour fibres unimodales Teil 1: OTDR für Einmodenfasern
(CEI 61746-1:2009) (IEC 61746-1:2009)

This European Standard was approved by CENELEC on 2011-01-02. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61746-1:2011 E
EN 61746-1:2011 - 2 -
Foreword
The text of document 86/347/FDIS, future edition 1 of IEC 61746-1, prepared by IEC TC 86, Fibre optics,
was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61746-1 on
2011-01-02.
This European Standard partially supersedes EN 61746:2005.
The main technical changes to EN 61746:2005 are:
– the adaptation of Clause 4;
– the deletion of Clause 10;
– the adaptation of some definitions and calculations;
– the change of graphical symbology to IEC/TR 61930.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-10-02
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2014-01-02
with the EN have to be withdrawn
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61746-1:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
[2] IEC 60793-1-1 NOTE  Harmonized as EN 60793-1-1.
[3] IEC 60794-1-2:2003 NOTE  Harmonized as EN 60794-1-2:2003 (not modified).
[4] IEC 60825-1 NOTE  Harmonized as EN 60825-1.
[5] IEC 60825-2 NOTE  Harmonized as EN 60825-2.
[6] IEC 61280-1-3:1998 NOTE  Harmonized as EN 61280-1-3:1999 (not modified).
[7] IEC 61300-3-2 NOTE  Harmonized as EN 61300-3-2.
[8] IEC 61300-3-6 NOTE  Harmonized as EN 61300-3-6.
__________
- 3 - EN 61746-1:2011
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60793-1-40 - Optical fibres - EN 60793-1-40 -
(mod) Part 1-40: Measurement methods and test
procedures - Attenuation
IEC 60793-2-50 - Optical fibres - EN 60793-2-50 -
Part 2-50: Product specifications - Sectional
specification for class B single-mode fibres

ISO/IEC 17025 - General requirements for the competence of EN ISO/IEC 17025 -
testing and calibration laboratories

ITU-T 2004 Definitions and test methods for linear, - -
Recommendation deterministic attributes of single-mode fibre
G.650.1 and cable
ITU-T 2002 Definitions and test methods for statistical and - -
Recommendation non-linear related attributes of single-mode
G.650.2 fibre and cable
IEC 61746-1 ®
Edition 1.0 2009-12
INTERNATIONAL
STANDARD
Calibration of optical time-domain reflectometers (OTDR) –
Part 1: OTDR for single mode fibres

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XC
ICS 33.180.01 ISBN 978-2-88910-553-3
– 2 – 61746-1 © IEC:2009(E)
CONTENTS
FOREWORD.6
INTRODUCTION.8
1 Scope.9
2 Normative references.9
3 Terms, definitions and symbols .9
4 Preparation for calibration.16
4.1 Organization .16
4.2 Traceability.16
4.3 Preparation.16
4.4 Test conditions .16
4.5 Documentation .16
5 Distance calibration – General .17
5.1 General .17
5.2 Location deviation model .17
5.3 Using the calibration results.19
5.4 Measuring fibre length .19
6 Distance calibration methods .20
6.1 General .20
6.2 External source method .20
6.2.1 Short description and advantage .20
6.2.2 Equipment .20
6.2.3 Calibration of the equipment .21
6.2.4 Measurement procedure .22
6.2.5 Calculations and results .23
6.2.6 Uncertainties .24
6.3 Concatenated fibre method.25
6.3.1 Short description and advantages .25
6.3.2 Equipment .25
6.3.3 Measurement procedures.27
6.3.4 Calculations and results .27
6.3.5 Uncertainties .28
6.4 Recirculating delay line method.29
6.4.1 Short description and advantage .29
6.4.2 Equipment .29
6.4.3 Measurement procedure .31
6.4.4 Calculations and results .31
6.4.5 Uncertainties .32
7 Loss calibration – General .33
7.1 General .33
7.2 Determination of the displayed power level F .33
7.3 Selection of an appropriate reference loss A .34
ref
7.4 Development of a test plan .35
7.5 Polarization dependence.37
7.6 Calculation of the calibration results.38
7.7 Using the calibration results.38
8 Loss calibration methods .38

61746-1 © IEC:2009(E) – 3 –
8.1 General .38
8.2 Fibre standard method.39
8.2.1 Short description and advantage .39
8.2.2 Equipment .39
8.2.3 Measurement procedure .40
8.2.4 Calculations and results .41
8.2.5 Uncertainties .41
8.3 External source method (see Figure 16).42
8.3.1 Short description and advantage .42
8.3.2 Equipment .42
8.3.3 Calibration of the reference loss.43
8.3.4 Measurement procedure .44
8.3.5 Calculations and results .45
8.3.6 Uncertainties .45
8.4 Splice simulator method.46
8.4.1 Short description and advantage .46
8.4.2 Equipment .46
8.4.3 Procedure.47
8.4.4 Calculations and results .49
8.4.5 Uncertainties .49
8.5 Power reduction method .50
8.5.1 Short description and advantage .
...

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