Live working - Methods for assessment of defects and verification of performance applicable to tools, devices and equipment

IEC 61318:2021 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.
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.
d) suppression of the term “conformity assessment”.
e) Introduction of the term “verification method” replacing “conformity assessment application”.

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”.

General Information

Status
Published
Publication Date
28-Jun-2021
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
29-Jun-2021
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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
IEC 61318:2021-06(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

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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;
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 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.]
---------------------- Page: 8 ----------------------
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]

---------------------- Page: 9 ----------------------
– 8 – IEC 61318:2021 © IEC 2021
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
test on a sample
[SOURCE: IEC 60050-151:2001, 151-16-20]
3.13
type test
test made on one or more items representative of the production
[SOURCE: IEC 60050-151:2001, 151-16-16, modified – the term “conformity”]
3.14
verification

confirmation, through the provision of objective evidence, that specified requirements have

been fulfilled

Note 1 to entry: The term “verified” is used to designate the corresponding status.

Note 2 to entry: Design verification is the application of tests and evaluation to assess that the design meets the

specified requirements.

[SOURCE: ISO 9000:2015, 3.8.12, modified – The Notes to entry have been modified.]

4 General

Principle methods for assessment and verification for live working products are detailed in this

document to assist product standard developers in prescribing the best means to demonstrate

that every finished tool, device and piece of equipment meet the standard requirements.

Non-conformance to product standards may results in defects. Product defects are

categorized into three levels; critical, major and minor defects as defined in Clause 3.

Assessment and verification involve tests, records of processes, sampling plans and quality

control documentation. The required records are determined through risk analysis,

classification of defects and corresponding methods of preventing these defects.

Assessment and verification records shall be kept by the manufacturer for at least five years

and in accordance with national or regional regulations.
5 Determination of defect type

In the application of this document, every significant defect shall be determined and then

classified according to type.

In order to determine the type of defects applicable to each product, it is necessary to

understand the intended functionality. The properties required in the finish product relate to

the application of the product. Where these properties are deficient, the resulting lack of

functionality will have an impact which shall be evaluated.
---------------------- Page: 10 ----------------------
IEC 61318:2021 © IEC 2021 – 9 –

Critical defects on tools, devices and equipment for live working are not acceptable. Major

defects of tools, devices and equipment for live working are likely to result in failure or in a

significant reduction of functionality, while minor defects do not reduce significantly the

functionality.

The evaluation of impact due to functional or other defects involves a risk analysis. The

ISO/IEC Guide 51 provides a framework for performing risk analysis.
6 Defects assessment methods
6.1 General

The main methods used in product manufacturing to prevent defects and ensure that standard

requirements are met are testing, process documentation and quality assessment. A guide to

developing general test methods (such as alternative test methods) is provided in Annex A.

6.2 Testing
6.2.1 General
Four categories of tests are included within live working product standards:
– type test;
– routine test;
– sampling test;
– acceptance test.
6.2.2 Type test

Type tests are performed on a relatively small number of items which are to be typical of all

products. Tests performed on these few are to determine basic design and functional

capabilities to their mechanical or electrical limits. Significant damage to the test object is

probable.

Type tests often involve rigorous laboratory tests requiring specialized equipment. Products

manufactured to the same specifications and using the same materials are expected to

perform and have the same characteristics as those used in type tests.

While type tests provide design verification, they are not usually suitable to be performed

continuously on production units. To verify some or all of the significant characteristics and

functionality, it may be useful to develop other practicable test methods which could be

applied to a wider number of items.
6.2.3 Routine test

Routine tests demonstrate performance and functionality according to specified levels and are

conducted on each manufactured product. While verifying a level of conformance to standard

requirements, these tests should not degrade or negatively impact the product.

Whenever the standard developer determines routine tests to be necessary those routine

tests should be used to determine critical defects.
---------------------- Page: 11 ----------------------
– 10 – IEC 61318:2021 © IEC 2021
6.2.4 Sampling test

Sampling tests are performed on either component parts of a product or finished items. These

involve only a prescribed amount or number of items and may involve testing of performance

to any level including destruction. Sampling plan parameters are determined statistically and

shall be followed precisely to yield meaningful results. ISO 2859-1:1999 provides rules to

follow in regard to determine sampling plans for these tests. The adequate acceptable quality

level (AQL) is determined according the risk analysis.
6.2.5 Acceptance test

An acceptance test is a contractual test to prove to the customer that the product meets the

customer’s specification. These tests are performed on a predetermined number of items in

the complete batch of ordered units and are of varying severity.

Acceptance tests may be destructive or potentially damage the product. In this case, the

disposition of the tested products should be considered. The product should be re-built or

destroyed to ensure that worker safety is not jeopardized from use of a damaged product.

6.3 Process documentation

Process documentation is a means of ensuring that all products are manufactured in a

traceable and consistent fashion. In this way, each item produced most exactly replicates

those used in type testing. Where production processes and materials are verified, function

and performance characteristics may be inferred in the finished product.
7 Verification methods
7.1 General

Verification methods involve the systematic means of identifying and preventing possible

product defects and ensuring that manufactured products meet the requirements of the

associated product standard.

Following a risk analysis, information pertaining to verification method including a rationale of

the defects (critical, major and minor) shall be provided in normative annexes of each product

standard. This information is best presented in tables where each defect is identified and

classified along with the required tests and relevant subclauses. An example presentation of

defects assessment information requirements for IEC 61481-2:2014 is presented in Annex B.

7.2 Identification and classification of defects

The classification of possible defects shall be based on a risk analysis, considering:

– the severity of the harm;
– and the probability of occurrence of the harm.
7.3 Requirements and tests

Each live working product standard provides appropriate means for ensuring that all

significant features of the product are measurable and verifiable. These include tests,

documentation, processes and other requirements detailed in each product standard.

For each defect identified, an explanation or appropriate clause or subclause of the product

standard shall be identified as shown in Table B.1 and Table B.2.
---------------------- Page: 12 ----------------------
IEC 61318:2021 © IEC 2021 – 11 –
Annex A
(informative)
Recommendations for developing test methods

The development of test methods should consider the elements of risk analysis of possible

product defects provided by the product standard. These include:
– description of the requirements the product has to meet;
– determination of the classification of defects (critical, major, minor);

– determination of relevant means (test, inspection, calculation, etc.) of addressing

requirements based on the classification of defects.

Test methods developed should provide consistent results and ensure the reproducibility of

the results within specified tolerances.

Non-destructive test methods or other means should be chosen whenever they can replace

destructive test methods while providing the same level of quality.
Test methods typically describe the following:
– functional characteristic to be tested;
– reagent and/or material;
– apparatus, test set-up, measurement instrument;
– preparation, preconditioning and preservation of test pieces;
– procedure;
– expression of results;
– method of calculation and precision of the test method;
– measurement uncertainty.
---------------------- Page: 13 ----------------------
– 12 – IEC 61318:2021 © IEC 2021
Annex B
(informative)
Example of defects assessment information tables
B.1 General

These examples taken from IEC 61481-2:2014 are provided to demonstrate the proper form of

presentation of defects assessment information required for each product standard.

Types of defects for phase comparators are identified, classified (critical, major or minor) and

associated with the appropriate subclause where the requirements and tests are described.

B.2 Classification and rationale of defects
Table B.1 is derived from Table D.1 of IEC 61481-2:2014.
Table B.1 – Classification of defects and associated requirements and tests
Requirements of IEC 61481-2:2014 Type of defects Test of
IEC 61481-
Critical Major Minor
2:2014
4.4.3 Minimum length of the insulating element for a X 5.4.1.2
phase comparator as a complete device
4.5 Correctness of the marking of the phase X 5.4.1.1
comparator
4.3.5.2 Leakage current along the insulating element of X 5.3.5.2
a phase comparator as a complete device
4.2.1 Clear indication of the status of the phase X 5.2.2
relationship
4.2.1.3 Effect of interference fields (continuous X
indication)
Protection against bridging for indoor/outdoor
4.3.2 X 5.3.2
type phase comparator
Protection against bridging for outdoor type X
5.3.3
phase comparator
4.3.3 Spark resistance X 5.3.4.3
4.2.5 Response time for phase comparators with one X
active signal
5.2.7.2
Response time for phase comparators with two X
active signals
4.2.4 Frequency dependence X 5.2.6.2
4.2.3 Temperature and humidity dependence of the X 5.4.7.2
indication
4.2.2 Clear perceptibility: only visual X 5.2.5.1.2
Clear perceptibility: visual and audible X 5.2.5.2.2
4.4.5 Vibration resistance X 5.4.4.2
4.4.6 Drop resistance X 5.4.5.2
4.4.7 Shock resistance X 5.4.6.2
4.2.7 Functioning of the testing element X 5.2.9.2
4.2.6 Power source dependability X 5.2.8.2
4.2.1.6 EMC X 5.2.3.2
---------------------- Page: 14 ----------------------
IEC 61318:2021 © IEC 2021 – 13 –
Requirements of IEC 61481-2:2014 Type of defects Test
...

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