SIST EN IEC 61318:2021
(Main)Live working - Methods for assessment of defects and verification of performance applicable to tools, devices and equipment
Live working - Methods for assessment of defects and verification of performance applicable to tools, devices and equipment
This document defines methods to assess defects and to verify that products after the
manufacturer process meet the requirements of the corresponding product standard.
The principles of assessment of defects for live working products are detailed in this
document to assist product standard developers in prescribing the best means to achieve
suitable quality of every finished tool, device and piece of equipment.
The following elements are not covered by the present document, but are included in each
product standard:
– type tests;
– provisions and description for routine, sampling and acceptance tests;
– identification and classification of defects;
– risk analysis.
This document does not cover conformity assessment of commercial shipments or
certifications.
Arbeiten unter Spannung – Maßnahmen zur Bewertung von Fehlern und zum Nachweis von Betriebseigenschaften für Werkzeuge, Geräte und Ausrüstungen
Travaux sous tension - Méthodes d'évaluation des défauts et vérification des performances applicables aux outils, dispositifs et équipement
IEC 61318:2021 Le présent document définit des méthodes d’évaluation des défauts et comment vérifier que des produits satisfont aux exigences de la norme de produit correspondante, après le processus de fabrication.
Les principes d'évaluation des défauts des produits pour travaux sous tension sont détaillés dans le présent document afin d'aider les développeurs de normes de produit à prescrire les meilleurs moyens pour obtenir une qualité adaptée de chaque outil, dispositif et équipement fini.
Les éléments suivants ne sont pas couverts par le présent document, mais sont inclus dans chaque norme de produit:
- essais de type;
- dispositions et description des essais individuels de série, des essais sur prélèvement et des essais de réception;
- identification et classification des défauts;
- analyse du risque.
Le présent document ne couvre pas l'évaluation de la conformité des livraisons commerciales ou des certifications.
Cette quatrième édition annule et remplace la troisième édition parue en 2007. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) modification de l'objet du présent document qui, de norme d'essai prescriptive, devient une norme destinée à aider les équipes de projets à atteindre la conformité à chaque norme de produit;
b) introduction d'un essai de conformité, d'un enregistrement de processus, d'une documentation de contrôle de la qualité, adaptés à la norme de produit;
c) modification de la procédure d'échantillonnage prescrite qui est remplacée par des essais sur prélèvement adaptés à la norme de produit;
d) suppression du terme “évaluation de la conformité”;
e) introduction du terme “méthode de vérification” pour remplacer “application de l'évaluation de la conformité”.
Delo pod napetostjo - Metode za ocenjevanje okvar in preverjanje delovne sposobnosti orodja, naprav in opreme
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 61318:2021
01-november-2021
Nadomešča:
SIST EN 61318:2008
Delo pod napetostjo - Metode za ocenjevanje okvar in preverjanje delovne
sposobnosti orodja, naprav in opreme
Live working - Methods for assessment of defects and verification of performance
applicable to tools, devices and equipment
Arbeiten unter Spannung – Maßnahmen zur Bewertung von Fehlern und zum Nachweis
von Betriebseigenschaften für Werkzeuge, Geräte und Ausrüstungen
Travaux sous tension - Méthodes d'évaluation des défauts et vérification des
performances applicables aux outils, dispositifs et équipement
Ta slovenski standard je istoveten z: EN IEC 61318:2021
ICS:
13.260 Varstvo pred električnim Protection against electric
udarom. Delo pod napetostjo shock. Live working
SIST EN IEC 61318:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 61318:2021
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SIST EN IEC 61318:2021
EUROPEAN STANDARD EN IEC 61318
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2021
ICS 13.260; 29.240.20; 29.260.99 Supersedes EN 61318:2008 and all of its amendments
and corrigenda (if any)
English Version
Live working - Methods for assessment of defects and
verification of performance applicable to tools, devices and
equipment
(IEC 61318:2021)
Travaux sous tension - Méthodes d'évaluation des défauts Arbeiten unter Spannung - Maßnahmen zur Bewertung von
et vérification des performances applicables aux outils, Fehlern und zum Nachweis von Betriebseigenschaften für
dispositifs et équipement Werkzeuge, Geräte und Ausrüstungen
(IEC 61318:2021) (IEC 61318:2021)
This European Standard was approved by CENELEC on 2021-08-03. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61318:2021 E
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SIST EN IEC 61318:2021
EN IEC 61318:2021 (E)
European foreword
The text of document 78/1339/FDIS, future edition 4 of IEC 61318, prepared by IEC/TC 78 “Live
working” was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 61318:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–05–03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–08–03
document have to be withdrawn
This document supersedes EN 61318:2008 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61318:2021 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:
IEC 61481-2:2014 NOTE Harmonized as EN 61481-2:2014 (not modified)
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015 (not modified)
ISO 16426:2002 NOTE Harmonized as EN ISO 16426:2002 (not modified)
2
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SIST EN IEC 61318:2021
IEC 61318
®
Edition 4.0 2021-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Live working – Methods for assessment of defects and verification of
performance applicable to tools, devices and equipment
Travaux sous tension – Méthodes d'évaluation des défauts et vérification des
performances applicables aux outils, dispositifs et équipement
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 13.260; 29.240.20; 29.260.99 ISBN 978-2-8322-9907-4
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 61318:2021
– 2 – IEC 61318:2021 © IEC 2021
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General . 8
5 Determination of defect type . 8
6 Defects assessment methods . 9
6.1 General . 9
6.2 Testing . 9
6.2.1 General . 9
6.2.2 Type test . 9
6.2.3 Routine test . 9
6.2.4 Sampling test. 10
6.2.5 Acceptance test . 10
6.3 Process documentation . 10
7 Verification methods . 10
7.1 General . 10
7.2 Identification and classification of defects . 10
7.3 Requirements and tests . 10
Annex A (informative) Recommendations for developing test methods . 11
Annex B (informative) Example of defects assessment information tables . 12
B.1 General . 12
B.2 Classification and rationale of defects . 12
B.3 Rationale of classification of defects . 13
Bibliography . 16
Table B.1 – Classification of defects and associated requirements and tests . 12
Table B.2 – Rationale for the classification of defects . 13
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SIST EN IEC 61318:2021
IEC 61318:2021 © IEC 2021 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
LIVE WORKING –
METHODS FOR ASSESSMENT OF DEFECTS AND
VERIFICATION OF PERFORMANCE APPLICABLE
TO TOOLS, DEVICES AND EQUIPMENT
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61318 has been prepared by IEC technical committee 78: Live
working.
This fourth edition cancels and replaces the third edition published in 2007. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) change of the purpose of the document from a prescriptive testing standard to a standard
assisting the project team in the conformance to respective product standard;
b) introduction of conformance test, record of process, quality control documentation,
adapted to the standard product;
c) change of prescribed sampling procedure to adapted sampling tests to the product
standard;
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SIST EN IEC 61318:2021
– 4 – IEC 61318:2021 © IEC 2021
d) suppression of the term “conformity assessment”;
e) Introduction of the term “verification method” replacing “conformity assessment
application”.
The text of this International Standard is based on the following documents:
FDIS Report on voting
78/1339/FDIS 78/1353/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement,
available at www.iec.ch/members_experts/refdocs. The main document types developed by
IEC are described in greater detail at www.iec.ch/standardsdev/publications.
In this document, the following characters are used:
– requirements: roman characters;
– terms defined in Clause 3: italics.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN IEC 61318:2021
IEC 61318:2021 © IEC 2021 – 5 –
INTRODUCTION
This document is applied by each IEC Live Working product standard for the purpose of
assessing whether or not each product meets the requirements of the relevant product
standard.
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SIST EN IEC 61318:2021
– 6 – IEC 61318:2021 © IEC 2021
LIVE WORKING –
METHODS FOR ASSESSMENT OF DEFECTS AND
VERIFICATION OF PERFORMANCE APPLICABLE
TO TOOLS, DEVICES AND EQUIPMENT
1 Scope
This document defines methods to assess defects and to verify that products after the
manufacturer process meet the requirements of the corresponding product standard.
The principles of assessment of defects for live working products are detailed in this
document to assist product standard developers in prescribing the best means to achieve
suitable quality of every finished tool, device and piece of equipment.
The following elements are not covered by the present document, but are included in each
product standard:
– type tests;
– provisions and description for routine, sampling and acceptance tests;
– identification and classification of defects;
– risk analysis.
This document does not cover conformity assessment of commercial shipments or
certifications.
2 Normative references
There are no normative referenced documents.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
acceptance test
contractual test to prove to the customer that the item meets certain conditions of its
specification
[SOURCE: IEC 60050-151:2001, 151-16-23, modified – The main term "hand-over test" has
been deleted.]
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SIST EN IEC 61318:2021
IEC 61318:2021 © IEC 2021 – 7 –
3.2
critical defect
any defect where judgement and experience indicate that it is likely to result in hazardous or
unsafe conditions for individuals using or depending on the product
3.3
harm
physical injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO IEC Guide 51:2014, 3.1, modified – Addition of "physical".]
3.4
hazard
potential source of harm
Note 1 to entry: The term hazard can be qualified in order to define its origin or the nature of the expected harm
(e.g. electric shock hazard, electric arc hazard, crushing hazard, cutting hazard, toxic hazard, fire hazard, drowning
hazard).
[SOURCE ISO IEC Guide 51:2014, 3.2, modified – Addition of Note 1 to entry.]
3.5
major defect
defect of product, other than critical, that is likely to result in failure, or to reduce significantly
the functionality of the product
3.6
minor defect
defect of product that is not likely to reduce significantly the functionality of the product
3.7
non-conformance
non-fulfilment of a requirement
[SOURCE: ISO 16426:2002, 3.15]
3.8
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO IEC Guide 51:2014, 3.9, modified – The note 1 to entry was deleted.]
3.9
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[SOURCE: ISO IEC Guide 51:2014, 3.10]
3.10
routine test
test made on each individual item during or after manufacture
[SOURCE: IEC 60050-151:2001, 151-16-17, modified – the term “conformity” was deleted]
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SIST EN IEC 61318:2021
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3.11
sampling plan
combination of sample size(s) to be used and associated lot acceptability criteria
[SOURCE: ISO 2859-1:1999, 3.1.17, modified – Deletion of the notes.]
3.12
sampling test
te
...
SLOVENSKI STANDARD
oSIST prEN IEC 61318:2020
01-februar-2020
Nadomešča:
SIST EN 61318:2008
Delo pod napetostjo - Ugotavljanje skladnosti za orodja, naprave in opremo
Live working - Conformity assessment applicable to tools, devices and equipment
Arbeiten unter Spannung - Konformitätsbewertung anwendbar auf Werkzeuge, Geräte
und Ausrüstungen
Travaux sous tension - Evaluation de la conformité applicable à l'outillage, au matériel et
aux dispositifs
Ta slovenski standard je istoveten z: prEN IEC 61318:2019
ICS:
13.260 Varstvo pred električnim Protection against electric
udarom. Delo pod napetostjo shock. Live working
oSIST prEN IEC 61318:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 61318:2020
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oSIST prEN IEC 61318:2020
78/1301/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61318 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-12-20 2020-03-13
SUPERSEDES DOCUMENTS:
78/1203/CD,78/1226A/CC
IEC TC 78 : LIVE WORKING
SECRETARIAT: SECRETARY:
France Mrs Sophie Chabin
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
TITLE:
Live working - Conformity assessment applicable to tools, devices and equipment
PROPOSED STABILITY DATE: 2023
NOTE FROM TC/SC OFFICERS:
Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
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oSIST prEN IEC 61318:2020
IEC CDV 61318 ED4 IEC: 2019 – 2 – 78/1301/CDV
1 CONTENTS
2 CONTENTS. 2
3 FOREWORD . 3
4 INTRODUCTION . 5
5 1 Scope . 6
6 2 Normative references . 6
7 3 Terms and definitions . 6
8 4 General . 8
9 5 Determination of defect type . 8
10 6 Conformity assessment methods. 8
11 6.1 General . 8
12 6.2 Testing . 8
13 6.2.1 Type test . 8
14 6.2.2 Routine test . 9
15 6.2.3 Sampling test . 9
16 6.2.4 Acceptance test . 9
17 6.3 Process documentation . 9
18 7 Conformity assessment application . 9
19 7.1 General . 9
20 7.2 Identification and classification of defects. 9
21 7.3 Requirements and tests . 10
22 Annex A (informative) Recommendations for developing test methods . 11
23 Annex B (informative) Example of conformity assessment information tables . 12
24 B.1 General . 12
25 B.2 Classification and rationale of defects . 12
26 B.3 Rationale of classification of defects . 13
27 Bibliography . 16
28 Table D.1 – Classification of defects and associated requirements and tests . 12
29 Table D.2 – Rationale for the classification of defects . 13
30
31
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oSIST prEN IEC 61318:2020
IEC CDV 61318 ED4 IEC: 2019 – 3 – 78/1301/CDV
32 INTERNATIONAL ELECTROTECHNICAL COMMISSION
33 ____________
34
35 LIVE WORKING –
36 CONFORMITY ASSESSMENT APPLICABLE
37 TO TOOLS, DEVICES AND EQUIPMENT
38
39
40 FOREWORD
41 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all
42 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-
43 operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to
44 other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available
45 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical
46 committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work.
47 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation.
48 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions
49 determined by agreement between the two organizations.
50 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
51 consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC
52 National Committees.
53 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees
54 in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,
55 IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
56 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently
57 to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication
58 and the corresponding national or regional publication shall be clearly indicated in the latter.
59 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment
60 declared to be in conformity with an IEC Publication.
61 6) All users should ensure that they have the latest edition of this publication.
62 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of
63 its technical committees and IEC National Committees for any personal injury, property damage or other damage of any
64 nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the
65 publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
66 8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications is
67 indispensable for the correct application of this publication.
68 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.
69 IEC shall not be held responsible for identifying any or all such patent rights.
70 International Standard IEC 61318 Ed.4 has been prepared by IEC technical committee 78: Live
71 working.
72 This fourth edition cancels and replaces the first edition which was issued as a technical report in
73 1994 with its Corrigendum 1 (2000), the second edition, withdrawn, which was issued as a standard in
74 2003 and the third edition issued as a standard in 2007. It includes the following significant technical
75 changes from the previous edition:
76 Change of the purpose of the document from a prescriptive testing standard to a standard assisting
77 the project team and the user in the conformance to respective product standards;
78 The text of this standard is based on the following documents:
FDIS Report on voting
78/xxx/FDIS 78/xxx/RVD
79 Full information on the voting for the approval of this standard can be found in the report on voting
80 indicated in the above table.
81 This standard has been drafted in accordance with the ISO/IEC Directives, Part 2.
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oSIST prEN IEC 61318:2020
IEC CDV 61318 ED4 IEC: 2019 – 4 – 78/1301/CDV
82 The committee has decided that the contents of this publication will remain unchanged until the
83 maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
84 related to the specific publication. At this date, the publication will be
85 • reconfirmed,
86 • withdrawn,
87 • replaced by a revised edition, or
88 • amended.
89
90
91
92
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oSIST prEN IEC 61318:2020
IEC CDV 61318 ED4 IEC: 2019 – 5 – 78/1301/CDV
93 INTRODUCTION
94 This standard is required to be applied by each IEC Live Working product standard for the purpose of
95 assessing whether or not each product meets the requirements of the relevant product standard.
96
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oSIST prEN IEC 61318:2020
IEC CDV 61318 ED4 IEC: 2019 – 6 – 78/1301/CDV
97 LIVE WORKING –
98 CONFORMITY ASSESSMENT APPLICABLE
99 TO TOOLS, DEVICES AND EQUIPMENT
100
101
102 1 Scope
103 This standard defines assessment methods for products to assure that they conform to the
104 requirements of the corresponding product.
105 The principles of conformity assessment for live working products are detailed in this standard to
106 assist product standard developers in prescribing the best means to achieve suitable quality of every
107 finished tool, device and piece of equipment.
108 The following elements are not covered by the present document, but are included in each product
109 standard:
110 - type tests;
111 - provisions and description for routine, sampling and acceptance tests;
112 - identification and classification of defects;
113 - risk analysis.
114 This standard does not cover conformity assessment of commercial shipments or certifications.
115 This standard is not a quality management system standard nor to be used for regulatory purposes.
116 2 Normative references
117 The following referenced documents are indispensable for the application of this document. For dated
118 references, only the edition cited applies. For undated references, the latest edition of the referenced
119 document (including any amendments) applies.
120 ISO Guide 51: 2014 Safety aspects - Guidelines for their inclusion in standards
121 ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes
122 indexed by acceptance quality limit (AQL) for lot-by-lot inspection
123 3 Terms and definitions
124 For the purposes of the present document, the following terms and definitions apply.
125 3.1
126 acceptance test
127 contractual test to prove to the customer that the item meets certain conditions of its specification
128 [SOURCE: IEC 60050-151:2001, 151-16-23
129 3.2
130 conformity assessment
131 any activity which assists in determining whether or not relevant requirements of a standard are
132 achieved in the finished product through direct or indirect means
133 [SOURCE: ISO/IEC Guide 7:1994, 3.1]
134 3.3
135 critical defect
136 any defect where judgement and experience indicates that it is likely to result in hazardous or unsafe
137 conditions for individuals using or depending on the product
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138 3.4
139 harm
140 physical injury or damage to the health of people, or damage to property or the environment
141 [SOURCE: ISO/IEC Guide 51:2014, 3.3]
142 3.5
143 hazard
144 potential source of harm
145 Note 1 to entry: The term hazard can be qualified in order to define its origin or the nature of the expected harm (e.g. electric shock hazard,
146 electric arc hazard, crushing hazard, cutting hazard, toxic hazard, fire hazard, drowning hazard).
147 [SOURCE ISO/IEC Guide 51:2014, 3.5, modified to cover live working application]
148 3.6
149 major defect
150 defect on product, other than critical, that is likely to result in failure, or to reduce significantly the
151 functionality of the product
152 3.7
153 minor defect
154 defect on product that is not likely to reduce significantly the functionality of the product
155 3.8
156 non-conformance
157 non-conformity
158 non-fulfilment of a requirement
159 [SOURCE: ISO 16426:2002, 3.15, modified by adjunction of a synonym]
160 3.9
161 risk
162 combination of the probability of occurrence of harm and the severity of that harm
163 [SOURCE: ISO/IEC Guide 51:2014, 3.9, modified: the note 1 to entry was deleted]
164 3.10
165 risk analysis
166 systematic use of available information to identify hazards and to estimate the risk
167 [SOURCE: ISO/IEC Guide 51:2014, 3.10]
168 3.11
169 routine test
170 conformity test made on each individual item during or after manufacture
171 [SOURCE: IEC 60050-151:2001, 151-16-17]
172 3.12
173 sampling plan
174 combination of sample size(s) to be used and associated lot acceptability criteria
175 [SOURCE: ISO 2859-1:1999, 3.1.17 modified by deleting the notes]
176 3.13
177 sampling test
178 test on a sample
179 [SOURCE: IEC 60058-151:2001, 151-16-20]
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180 3.14
181 type test
182 conformity test made on one or more items representative of the production
183 [SOURCE: IEC 60050:2001, 151-16-16]
184 4 General
185 Principles of conformity assessment for live working products are detailed in this standard to assist
186 product standard developers (manufacturers, users, etc.) in prescribing the best means to achieve
187 conformance to the standard requirements of every finished tool, device and piece of equipment.
188 Non-conformance to product standards may results in defects. Product defects are categorized into
189 three levels; critical, major and minor defects as defined in 3.
190 Conformity assessment involves tests, records of processes, sampling plans and quality control
191 documentation. The required records are determined through risk analysis, classification of defects
192 and corresponding methods of preventing these defects.
193 Conformity assessment records shall be kept by the manufacturer for at least five years and in
194 accordance with national or regional regulations.
195 5 Determination of defect type
196 In the application of this standard, every significant defect shall be determined and then classified
197 according to type.
198 In order to determine the type of defects applicable to each product, it is necessary to understand the
199 intended functionality. The properties required in the finish product relate to the application of the
200 product. Where these prope
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