IEC 61318:2007
(Main)Live working - Conformity assessment applicable to tools, devices and equipment
Live working - Conformity assessment applicable to tools, devices and equipment
Provides elements for product conformity assessment. Critical defects on tools, devices and equipment for live working are not acceptable. Major defects on 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. This standard defines assessment methods for products having completed production phase to assure that they conform to the requirements of the corresponding product standard. It is to be used in conjunction with live working corresponding product standards. The following elements are not covered by the present document, but are included in each product standard: - type tests; - provisions and description for sampling and routine tests; - the identification and classification of the corresponding defects resulting from a risk analysis. This third edition cancels and replaces the first edition which was issued as a technical report in 1994 with its Corrigendum 1 (2000), and the second edition, withdrawn, which was issued as a standard in 2003. It includes the following significant technical changes from the previous edition: - change of the purpose of the document from a support to standard writers to a standard for assessing the conformity by testing of products having completed the production phase; - clarification of the definitions of critical, major and minor defects; - specification of ISO 2859 for the manufacturers to define the appropriate sampling plans; - review of the acceptance quality limit (AQL) to specify lower limits.
Travaux sous tension - Evaluation de la conformité applicable à l'outillage, au matériel et aux dispositifs
Fournit des éléments destinés à l'évaluation de la conformité de produit. Les défauts critiques sur l'outillage, le matériel et les dispositifs pour les travaux sous tension ne sont pas acceptables. Les défauts majeurs sur l'outillage, le matériel et les dispositifs pour les travaux sous tension sont susceptibles de provoquer une défaillance ou de réduire d'une manière appréciable la fonctionnalité du produit tandis que les défauts mineurs ne réduisent pas d'une manière appréciable la fonctionnalité du produit. La présente norme définit des méthodes d'évaluation des produits finis issus de production pour s'assurer qu'ils se conforment aux exigences de la norme de produit correspondante. Elle est conçue pour être utilisée conjointement avec les normes de produit pour les travaux sous tension. Les éléments suivants ne sont pas couverts par le présent document mais sont inclus dans chaque norme de produit: - les essais de type; - les dispositions et description des essais de prélèvement et des essais individuels de série; - l'identification et la classification des défauts correspondants et qui résultent d'une analyse du risque. Cette troisième édition annule et remplace la première édition parue sous forme de rapport technique en 1994 avec son Corrigendum 1 (2000), et la seconde édition publiée en 2003, retirée. Elle inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - le changement de propos du document qui d'un support aux rédacteurs de normes devient une norme pour évaluer par des essais la conformité des produits issus de production; - la clarification des définitions des défauts critiques, majeurs et mineurs; - la spécification de l'ISO 2859 pour la détermination par les fabricants des plans d'échantillonnage appropriés; - la revue du niveau de qualité acceptable (NQA) pour spécifier des valeurs plus faibles.
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IEC 61318
Edition 3.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Live working – Conformity assessment applicable to tools, devices and
equipment
Travaux sous tension – Evaluation de la conformité applicable à l'outillage, au
matériel et aux dispositifs
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IEC 61318
Edition 3.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Live working – Conformity assessment applicable to tools, devices and
equipment
Travaux sous tension – Evaluation de la conformité applicable à l'outillage, au
matériel et aux dispositifs
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
N
CODE PRIX
ICS 13.260; 29.240.20; 29.260.99 ISBN 2-8318-9449-2
– 2 – 61318 © IEC:2007
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.6
2 Normative references .6
3 Terms and definitions .6
4 General .8
5 Categories of tests .8
5.1 Overview .8
5.2 Routine tests .9
5.3 Sampling tests.9
5.4 Acceptance tests.9
6 Sampling procedure .9
Annex A (informative) Acceptance test.10
Annex B (informative) Recommendations for developing and applying equivalent
alternative test methods.11
Annex C (informative) Classification of defects and tests to be allocated .12
Bibliography.14
Table C.1 – Classification of defects and associated requirements and tests .13
61318 © IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
LIVE WORKING –
CONFORMITY ASSESSMENT 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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
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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 third edition cancels and replaces the first edition which was issued as a technical report
in 1994 with its Corrigendum 1 (2000), and the second edition, withdrawn, which was issued
as a standard in 2003. It includes the following significant technical changes from the
previous edition:
– change of the purpose of the document from a support to standard writers to a standard
for assessing the conformity by testing of products having completed the production
phase;
– clarification of the definitions of critical, major and minor defects;
– specification of ISO 2859 for the manufacturers to define the appropriate sampling plans;
– review of the acceptance quality limit (AQL) to specify lower limits.
– 4 – 61318 © IEC:2007
The text of this standard is based on the following documents:
FDIS Report on voting
78/705/FDIS 78/713/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
61318 © IEC:2007 – 5 –
INTRODUCTION
This publication provides elements for product conformity assessment.
This standard is specified in each IEC product standard for live working for the purpose of
assessing that products having completed the production phase meet the requirements of the
relevant product standard.
It can be used as a basis for production certification.
TC 78 prepares product standards which include requirements and normative tests for design
input (type tests).
Product conformity assessment elements related to the production phase (among them is the
procedure to associate routine and sampling tests to the classification of defects) are included
in the present standard.
This publication does not cover conformity of commercial shipments. Shipments can contain
products coming from several production batches. Batches are here understood as related to
production.
This publication is not a quality management systems standard.
– 6 – 61318 © IEC:2007
LIVE WORKING –
CONFORMITY ASSESSMENT APPLICABLE
TO TOOLS, DEVICES AND EQUIPMENT
1 Scope
This International Standard provides elements for product conformity assessment. Critical
defects on tools, devices and equipment for live working are not acceptable. Major defects on
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.
This standard defines assessment methods for products having completed production phase
to assure that they conform to the requirements of the corresponding product standard. It is to
be used in conjunction with live working corresponding product standards.
The following elements are not covered by the present document, but are included in each
product standard:
– type tests;
– provisions and description for sampling and routine tests;
– the identification and classification of the corresponding defects resulting from a risk
analysis.
2 Normative references
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.
ISO 2859 (all parts), Sampling procedures for inspection by attributes
3 Terms and definitions
For the purposes of the present document, the following terms and definitions apply.
NOTE Some of the terms and definitions below have been modified in order to apply more exactly to live working
product standards.
3.1
acceptance quality limit
AQL
maximum per cent defective (or the maximum number of defects per 100 items) for purposes
of sampling inspections, that can be considered satisfactory as a process average
[ISO 2859-1, Definition 3.1.26, modified]
3.2
acceptance test
contractual test to prove to the customer that the item(s) meet(s) certain conditions of its
specification
[IEV 151-16-23, modified]
61318 © IEC:2007 – 7 –
3.3
conformity assessment
any activity concerned with determining directly or indirectly that relevant requirements are
fulfilled
NOTE Examples of conformity-assessment activities are sampling, testing and inspection, evaluation, verification
and assurance of conformity (supplier’s declaration, certification), registration, accreditation and approval as well
as their combinations.
[ISO/IEC Guide 7, Definition 3.1]
3.4
critical defect
defect on product that judgement and experience indicate is likely to result in hazardous or
unsafe conditions for individuals using and depending on the product
3.5
lot size
number of items in a lot to be evaluated for standard conformance
[ISO 2859-1, Definition 3.1.14, modified]
3.6
major defect
defect on product, other than critical, that is likely to result in failure, or to reduce significantly
the functionality of the product
3.7
minor defect
defect on product that is not likely to reduce significantly the functionality of the product
3.8
responsible authority
concept used to maintain the neutrality of this document (primarily for specification purposes),
irrespective of whether it is being invoked or applied by the first, second or third party
NOTE The responsible authority may be:
a) the quality department within a supplier's organization (first party);
b) the purchaser or procurement organization (second party);
c) an independent verification or certification authority (third party);
d) any of a), b) or c), differing according to function as described in a written agreement between two of the
parties, for example a document between supplier and purchaser.
[ISO 2859-1, Definition 3.1.12, modified]
3.9
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO/IEC Guide 51, Definition 3.2]
3.10
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[ISO/IEC Guide 51, Definition 3.10]
– 8 – 61318 © IEC:2007
3.11
routine test
test performed on each item during or after production to ascertain whether it complies with
certain criteria
[IEV 151-16-17, modified]
3.12
sample size
number of items in the sample
[ISO 2859-1, Definition 3.1.16]
3.13
sampling plan
combination of sample size(s) to be used and associated lot acceptability criteria
[ISO 2859-1, Definition 3.1.17]
3.14
sampling test
test on a sample
[IEV 151-16-20]
3.15
type test
test performed on one or more items representative of the production, made to show that the
design of the product meets certain requirements
[IEV 151-16-16, modified]
4 General
The conformity assessment of every finished tool, device and equipment having completed
the production phase can be achieved by the application of the provisions of this standard.
Alternative test methods based on quality and safety assessment (see Annex B) are
acceptable if they warrant the same level of conformity and safety and are validated by a
“responsible authority”.
NOTE Where appropriate, the product standards should include alternative test methods when the methods
specified at the type test level are found less or not practicable at the production level. Nevertheless, it could
happen that a test method provided in the product standard is not found adequate by a manufacturer. In such case,
the present standard permits to replace this test by another equivalent alternative test.
These alternative test methods shall be justified, described, maintained and recorded.
NOTE To justify an alternative test method the manufacturer will have to provide objective evidence that it
warrants the same level of conformity and safety.
In any cases test results shall be recorded and kept by the manufacturer in accordance with
national or regional regulations but not less than five years.
5 Categories of tests
5.1 Overview
Four categories of tests are currently included within live working product standards:
61318 © IEC:2007 – 9 –
– type tests (not covered by this standard),
– routine tests (see 5.2),
– sampling tests (see 5.3),
– acceptance tests (see 5.4 and Annex A).
This standard is intended to be used for managing routine and sampling tests in the purpose
of conformity assessment during the production phase.
This standard provides an informative annex related to acceptance tests.
NOTE Other tests may be included in the conformity assessment documentation – for example, tests
recommended for use during production to monitor the production process, but they are not covered by this
standard.
5.2 Routine tests
Routine tests shall be performed to avoid critical defect.
An annex within each product standard identifies critical defects and associated tests (see a
typical example in Annex C). To be in accordance with the present standard, these tests or
alternative test methods as specified in Clause 4 shall be used as routine tests.
5.3 Sampling tests
Sampling tests shall be performed to avoid major and minor defects.
An annex within each product standard identifies major and minor defects and associated
tests (see a typical example in Annex C). To be in accordance with the present standard,
these tests or alternative test methods as specified in Clause 4 shall be used as sampling
tests.
Sampling procedures and the validation of test results shall be in conformance with Clause 6.
5.4 Acceptance tests
Annex A provides guidance on the use of acceptance tests at customer’s request within the
frame of a commercial contract.
6 Sampling procedure
The sampling procedure is based on the availability of non-destructive sampling tests. When
the tests proposed within the product standard are destructive, the manufacturer could
propose if possible alternative non-destructive test methods according to Clause 4.
The manufacturer shall define a sampling plan, using the rules of ISO 2859. According to the
nature of the product and the lot size, the manufacturer will select the more appropriate
sampling parameters while respecting the following:
– major defects : AQL ≤ 2,5;
– minor defects : AQL ≤ 4.
– 10 – 61318 © IEC:2007
Annex A
(informative)
Acceptance test
An acceptance test is a contractual test to prove to the customer that the item(s) or product in
question meet(s) the customer’s specification.
If the customer requests additional tests or increase of the stringency of the sampling
procedure this should be acceptable after agreement between the customer and the supplier.
In that case the customer should include this within his own specification.
The disposition of tested products should be considered. If a test is destructive the product
should be re-built, if possible, or destroyed to insure that worker safety is not jeopardized
from the later use of a damaged product.
If the test is non-destructive and the products are not damaged, they could be (or not)
included in the customer order as a normal part of the order.
61318 © IEC:2007 – 11 –
Annex B
(informative)
Recommendations for developing and applying equivalent
alternative test methods
The development of an equivalent alternative test method should consider the elements of
risk analysis of product defects provided by the product standard:
– description of the requirements the product has to meet;
– determination of the classification of defects (critical, major, minor);
– definition and statement – based on the classification of defects – of adequate
requirements and relevant means (test, inspection, calculation, etc.).
The alternative test methods developed should provide consistent results and ensure the
reproducibility of the results.
The accuracy of the chosen test method should be such as to allow unambiguous
determination of whether the value of the characteristic to be assessed lies (where
appropriate) within specified tolerances.
Non-destructive test methods should be chosen whenever they can replace, within the same
level of confidence, destructive test methods.
The alternative test methods should provide the following:
– principle;
– reagent and/or material (when required);
– apparatus, test set-ups;
– preparation and preservation of test pieces;
– procedure;
– expression of results, including method of calculation and precision of the test method,
measurement uncertainty (if required).
– 12 – 61318 © IEC:2007
Annex C
(informative)
Classification of defects and tests to be allocated
C.1 General
This annex gives a typical example of the information required to be included in a normative
annex of each product standard following a risk analysis on the performance of the relevant
product.
It identifies the requirements and tests with the relevant subclauses, and indicates the type of
associated defects.
In reference to ISO/IEC Guide 51, the classification of defects will be based on a risk analysis
taking into account:
– the severity of the harm;
– the probability of occurrence of the harm.
C.2 Classification of defects and tests to be allocated for evaluating the
conformity of the production to the requirements – Example taken from
IEC 61243-1
This example was developed to address the level of defects of manufactured voltage
detectors (critical, major or minor) in a consistent manner. Table C.1 identifies the
requirements and tests with the associated defects.
61318 © IEC:2007 – 13 –
Table C.1 – Classification of defects and associated requirements and tests
Type of defects
Requirements Tests
Critical Major Minor
Subclause of Subclause of
IEC 61243-1 IEC 61243-1
4.4.1 Visual and dimensional inspection X 6.4.1
4.4.2
4.5
4.6
4.5 Markings X 6.4.7
(durability)
4.4.3 Grip force and deflection X 6.4.2
4.2.1.1 Threshold voltage X 6.2.1.2
4.3.2 Protection against bridging for indoor/outdoor type X 6.3.1
voltage detector
4.3.2 Protection against bridging for outdoor type voltage 6.3.2
detector
4.3.3 Spark resistance X 6.3.3
4.2.7 Check of testing element X 6.2.7
4.2.2.1 Clear perceptibility of audible indication X 6.2.3
4.2.2.2 Clear perceptibility of visual indication X 6.2.2
4.2.1 Clear indication X 6.2.1
5.1.2 Leakage current for voltage det
...








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