SIST EN 61746-1:2011
(Main)Calibration of Optical Time-Domain Reflectometers (OTDR) - Part 1: OTDR for single-mode fibres (IEC 61746-1:2009)
Calibration of Optical Time-Domain Reflectometers (OTDR) - Part 1: OTDR for single-mode fibres (IEC 61746-1:2009)
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
Kalibrierung optischer Rückstreumessgeräte (OTDR) - Teil 1: OTDR für Einmodenfasern (IEC 61746-1:2009)
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).
Étalonnage des réflectomètres optiques dans le domaine temporel (OTDR) - Partie 1: OTDR pour fibres unimodales (CEI 61746-1:2009)
L'ISO 13485:2003 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables aux dispositifs médicaux et aux services associés.
Le principal objectif de l'ISO 13485:2003 est de faciliter la mise en oeuvre d'exigences réglementaires harmonisées en matière de dispositifs médicaux, dans le cadre des systèmes de management de la qualité. Par conséquent, elle comprend certaines exigences particulières concernant les dispositifs médicaux, mais certaines exigences de l'ISO 9001, non appropriées en tant qu'exigences réglementaires, en sont exclues. Du fait de ces exclusions, les organismes dont les systèmes de management de la qualité sont conformes à l'ISO 13485:2003 ne peuvent revendiquer la conformité à l'ISO 9001 que si leurs systèmes de management de la qualité sont conformes à l'ensemble des exigences de l'ISO 9001.
Toutes les exigences de l'ISO 13485:2003 sont spécifiques aux organismes fournissant des dispositifs médicaux, indépendamment du type ou de la taille de l'organisme.
Le fait que des exigences réglementaires autorisent l'exclusion des systèmes de contrôle de conception et de développement peut servir à justifier leur exclusion du système de management de la qualité. Ces réglementations peuvent prévoir d'autres dispositions qui doivent être appliquées dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2003 correspondent à l'exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une ou plusieurs exigences définies à l'Article 7 de l'ISO 13485:2003 ne peuvent être appliquées en raison de la nature du ou des dispositifs médicaux auxquels s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette (ces) exigence(s) dans son système de management de la qualité.
Les processus requis par l'ISO 13485:2003, qui sont applicables au(x) dispositif(s) médical (médicaux) mais non adoptés par l'organisme, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité.
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.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2011
1DGRPHãþD
SIST EN 61746:2005
.DOLEULUDQMHRSWLþQLKUHIOHNWRPHWURYYþDVRYQHPSURVWRUX 27'5 GHO 27'5]D
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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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