Dependability management -- Part 2: Guidelines for dependability management

Provides guidelines for dependability management of product design, development, evaluation and process enhancements. Life cycle models are used to describe product development or project phases. Applicable for detailed planning and implementation of a dependability programme to meet specific product needs.

Zuverlässigkeitsmanagement -- Teil 2: Leitfaden zum Zuverlässigkeitsmanagement

Gestion de la sûreté de fonctionnement -- Partie 2: Lignes directrices pour la gestion de la sûreté de fonctionnement

Fournit les lignes directrices pour la gestion de la sûreté de fonctionnement en matière de conception, de développement, d'évaluation du produit et d'amélioration du processus. Des modèles de cycle de vie sont utilisés pour décrire les phases de développement du produit ou du projet. La présente partie de la EN 60300 s'applique à une planification et une mise en uvre détaillées d'un programme de sûreté de fonctionnement destiné à répondre à des besoins spécifiques du produit.

Vodenje zagotovljivosti – 2. del: Program zagotovljivosti (IEC 60300- 2:2004)

General Information

Status
Withdrawn
Publication Date
31-Aug-2004
Withdrawal Date
22-Jul-2018
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
23-Jul-2018
Due Date
15-Aug-2018
Completion Date
23-Jul-2018

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SLOVENSKI STANDARD
SIST EN 60300-2:2004
01-september-2004
1DGRPHãþD
SIST EN 60300-2:2002
Vodenje zagotovljivosti – 2. del: Program zagotovljivosti (IEC 60300- 2:2004)
Dependability management -- Part 2: Guidelines for dependability management
Zuverlässigkeitsmanagement -- Teil 2: Leitfaden zum Zuverlässigkeitsmanagement
Gestion de la sûreté de fonctionnement -- Partie 2: Lignes directrices pour la gestion de
la sûreté de fonctionnement
Ta slovenski standard je istoveten z: EN 60300-2:2004
ICS:
03.120.01 Kakovost na splošno Quality in general
21.020 =QDþLOQRVWLLQQDþUWRYDQMH Characteristics and design of
VWURMHYDSDUDWRYRSUHPH machines, apparatus,
equipment
SIST EN 60300-2:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60300-2:2004

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SIST EN 60300-2:2004
EUROPEAN STANDARD EN 60300-2
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2004

ICS 03.100.40; 03.120.01 Supersedes EN 60300-2:1996


English version


Dependability management
Part 2: Guidelines for dependability management
(IEC 60300-2:2004)


Gestion de la sûreté de fonctionnement Zuverlässigkeitsmanagement
Partie 2: Lignes directrices pour la gestion Teil 2: Leitfaden zum
de la sûreté de fonctionnement Zuverlässigkeitsmanagement
(CEI 60300-2:2004) (IEC 60300-2:2004)






This European Standard was approved by CENELEC on 2004-04-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60300-2:2004 E

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SIST EN 60300-2:2004
EN 60300-2:2004 - 2 -
Foreword
The text of document 56/913/FDIS, future edition 2 of IEC 60300-2, prepared by IEC TC 56,
Dependability, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60300-2 on 2004-04-01.
This European Standard supersedes EN 60300-2:1996.
Significant technical changes with regard to EN 60300-2:1996 are:
a) structural and terminological alignment with ISO;
b) focus on system processes;
c) provision of additional guidelines in annexes to facilitate applications.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2005-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-04-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60300-2:2004 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 60300-1 NOTE Harmonized as EN 60300-1:2003 (not modified).
IEC 60300-3-12 NOTE  Harmonized as EN 60300-3-12:2004 (not modified).
IEC 60812 NOTE  Harmonized as HD 485 S1:1987 (not modified).
IEC 61025 NOTE  Harmonized as HD 617 S1:1992 (not modified).
IEC 61164 NOTE Harmnonized as EN 61164:2004 (not modified)
ISO 9000 NOTE Harmonized as EN ISO 9000:2000 (not modified).
__________

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SIST EN 60300-2:2004
- 3 - EN 60300-2:2004
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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 60300-3-1 2003 Dependability management - -
Part 3-1: Application guide - Analysis
techniques for dependability - Guide on
methodology

IEC 61014 1989 Programmes for reliability growth - -

ISO/IEC 15026 1998 Information technology - System and - -
software integrity levels

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SIST EN 60300-2:2004

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SIST EN 60300-2:2004
NORME
CEI
INTERNATIONALE IEC
60300-2
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2004-03
Gestion de la sûreté de fonctionnement –
Partie 2:
Lignes directrices pour la gestion
de la sûreté de fonctionnement
Dependability management –
Part 2:
Guidelines for dependability management
© IEC 2004 Droits de reproduction réservés ⎯ Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch  Web: www.iec.ch
CODE PRIX
XA
Commission Electrotechnique Internationale PRICE CODE
International Electrotechnical Commission
ɆɟɠɞɭɧɚɪɨɞɧɚɹɗɥɟɤɬɪɨɬɟɯɧɢɱɟɫɤɚɹɄɨɦɢɫɫɢɹ
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope.11
2 Normative references .11
3 Terms and definitions .11
4 Dependability management system .19
5 Management responsibility .21
5.1 Management function on dependability.21
5.2 Meeting customer dependability needs.23
5.3 Dependability policy and regulatory implications.23
5.4 Dependability programmes .25
5.5 Management representative .25
5.6 Management review .25
6 Resource management.25
6.1 Provision of resources.25
6.2 Resource planning, development and maintenance .27
6.3 Outsourcing.29
7 Product realization .29
7.1 Planning for product realization .29
7.2 Tailoring of dependability programmes .31
7.3 Application of dependability plan .31
7.4 Supply-chain management .33
8 Measurement, analysis and improvement .33
8.1 Dependability measurement .33
8.2 Dependability monitoring and assurance .35
8.3 Dependability assessment and analysis .35
8.4 Use of dependability information .35
8.5 Measurement of results .37
8.6 Dependability improvement .39
Annex A (informative) Dependability programme elements and tasks for systems,
hardware and software applications .43
Annex B (informative) Product life cycle phases.71
Annex C (informative) Association of product life cycle phases with the applicable
dependability elements and tasks .75
Annex D (informative) Process steps and standards for managing dependability.79
Annex E (informative) Questions for dependability management review .85
Annex F (informative) Guidelines for the tailoring process.89
Annex G (informative) Classification of dependability standards with the life cycle
phases in which they are applicable.93
Bibliography.101
Figure 1 – Process steps for managing dependability.19

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
DEPENDABILITY MANAGEMENT –
Part 2: Guidelines for dependability management
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
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 60300-2 has been prepared by IEC technical committee 56:
Dependability.
This second edition cancels and replaces the first edition, published in 1995, as well as
IEC 60300-3-6 (1997). This edition constitutes a technical revision.
This edition includes the following significant technical changes with regard to the previous
edition:
a) structural and terminological alignment with ISO;
b) focus on system processes;
c) provision of additional guidelines in annexes to facilitate applications.

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
56/913/FDIS 56/934/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
2010. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 9 –
INTRODUCTION
Dependability deals with the availability performance of a product. The factors influencing
availability performance are reliability, maintainability and maintenance support performance.
Dependability is a technical discipline that needs to be managed in order to achieve its
objectives and benefits. Dependability management should provide a clear customer focus. It
should be incorporated into an organization’s overall management system to coordinate
dependability activities for cost-effective results.
This part of IEC 60300 provides guidelines on dependability management. It supports the top-
level dependability management system standard IEC 60300-1 by identifying and referencing
relevant processes and methods for a broad range of products. This standard links the
management process steps with applicable dependability standards to foster continual
improvement.
The concept of product life cycle is introduced to deal with the significance of dependability
activities and timing for their effective implementation. The association of product life cycle
phases with the applicable dependability programme elements and tasks are presented to
facilitate tailoring of dependability programmes to meet specific project needs.
This standard outlines the generic process for dependability applications based on
successfully applied industry practices. It can be incorporated into the management systems
of large corporations as well as being adaptable to small businesses.
Time-dependent reliability, maintainability and maintenance support performance
characteristics in products are addressed.
This standard references other published TC 56 standards and also makes reference to
several ISO/IEC standards as well as some sector specific reliability standards. These
references are listed in the bibliography.
Annex A provides a summary description of the elements and tasks of a dependability
programme for application.
Annex B defines the product life cycle phases.
Annex C presents an association of product life cycle phases with the applicable
dependability elements and tasks.
Annex D presents process steps and standards for managing dependability.
Annex E provides a list of questions to facilitate dependability management review.
Annex F provides guidelines for the tailoring process.
Annex G presents the classification of dependability standards with the life cycle phases.

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 11 –
DEPENDABILITY MANAGEMENT –
Part 2: Guidelines for dependability management
1 Scope
This part of IEC 60300 provides guidelines for dependability management of product design,
development, evaluation and process enhancements. Life cycle models are used to describe
product development or project phases. A tailoring process is recommended for the selection
of relevant dependability programme tasks for time-phased implementation to meet varied
user needs.
This part of IEC 60300 is applicable for detailed planning and implementation of a
dependability programme to meet specific product needs. The tailoring process provides a
method for selection of dependability programme elements and associated processes from a
product or project perspective. This standard is applicable to all organizations, during all life-
cycle phases and in any contract situation, regardless of type, size and product provided.
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.
IEC 60300-3-1, Dependability management – Part 3-1: Application guide – Analysis
techniques for dependability – Guide on methodology
IEC 61014, Programmes for reliability growth
ISO/IEC 15026, Information technology – System and software integrity levels
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE 1 Certain terms and definitions are taken from IEC 60050(191) and IEC 60300-1.
NOTE 2 ISO 9000 is used as a reference to quality vocabulary.
3.1
dependability
collective term used to describe the availability performance and its influencing factors:
reliability performance, maintainability performance and maintenance support performance
NOTE Dependability is used only for general descriptions in non-quantitative terms.
[IEC 60050, 191-02-03]

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 13 –
3.2
dependability management
coordinated activities to direct and control an organization with regard to dependability
NOTE Dependability management is part of an organization’s overall management.
[IEC 60300-1, definition 3.2]
3.3
dependability management system
management system to direct and control an organization with regard to dependability
NOTE 1 The dependability management system of an organization is part of its overall management system.
NOTE 2 The organizational structure, responsibilities, procedures, processes and resources used for managing
dependability are often referred to as a dependability programme.
[IEC 60300-1, definition 3.3]
3.4
dependability plan
document setting out the specific dependability practices, resources and sequences of
activities relevant to a particular product, contract or project
[IEC 60300-1, definition 3.4]
3.5
dependability programme element
set of dependability programme tasks, pertaining to a specific subject area
3.6
dependability programme task
set of activities addressing specific dependability aspects of a product
3.7
product
result of a process
NOTE 1 There are four generic product categories, as follows:
– services (e.g. transport);
– software (e.g. computer program, dictionary);
– hardware (e.g. engine mechanical part);
– processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then
called service, software, hardware or processed material depends on the dominant element. For example, the
offered product "automobile" consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid),
software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the
salesman).
NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier
and customer and is generally intangible. Provision of a service can involve, for example, the following:
– an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
– an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare
a tax return);
– the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
– the creation of ambience for the customer (e.g. in hotels and restaurants).

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 15 –
Software consists of information and is generally intangible and can be in the form of approaches, transactions or
procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally
tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as
goods.
NOTE 3 Quality assurance is mainly focussed on intended product.
[ISO 9000, definition 3.4.2]
NOTE 4 In the context of dependability, a product may be simple (e.g. a device, a software algorithm) or complex
(e.g. a system or an integrated network comprising hardware, software and human elements and support facilities
and activities).
[IEC 60300-1, definition 3.5]
3.8
system
set of interrelated or interacting elements
[ISO 9000, definition 3.2.1]
NOTE 1 In the context of dependability, a system will have
a) a defined purpose expressed in terms of intended functions,
b) stated conditions of operation/use,
c) defined boundaries.
NOTE 2 The structure of a system may be hierarchical.
[IEC 60300-1, definition 3.6]
3.9
reliability (performance)
ability of an item to perform a required function under given conditions for a given time
interval
[IEC 60050, 191-02-06, modified]
3.10
maintainability (performance)
ability of an item under given conditions of use, to be retained in, or restored to, a state in
which it can perform a required function, when maintenance is performed under given
conditions and using stated procedures and resources
[IEC 60050, 191-02-07, modified]
3.11
maintenance support performance
ability of a maintenance organization, under given conditions, to provide upon demand, the
resources required to maintain an item, under a given maintenance policy
[IEC 60050, 191-02-08, modified]
3.12
integrity level
denotation of a range of values of a property of an item necessary to maintain system risks
within tolerable limits
NOTE For items that perform mitigating functions, the property is the reliability with which the item has to perform
the mitigating function. For items whose failure can lead to a threat, the property is the limit on the frequency of the
failure.
[ISO/IEC 15026, definition 3.9 modified]

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 17 –
3.13
item
entity
any part, component, device, subsystem, functional unit, equipment or system that can be
individually considered
NOTE An item may consist of hardware, software or both, and may also in particular cases, include people.
[IEC 60050, 191-01-01, modified]
3.14
process
set of interrelated activities utilizing resources to transform inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Processes in an organization are generally planned and carried out under controlled conditions to add
value.
NOTE 3 A process where the conformity of the resulting product cannot be readily or economically verified is
frequently referred to as a “special process”.
[ISO 9000, definition 3.4.1, modified]
3.15
supply-chain
coordinated set of management processes linking the activities of the supplier, the
organization and the customer to meet a common objective
3.16
management
coordinated activities to direct and control an organization
NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with
authority and responsibility for the conduct and control of an organization. When “management” is used in this
sense it should always be used with some form of qualifier to avoid confusion with the concept “management”
defined above. For example, “management shall…” is deprecated whereas “top management shall…” is
acceptable.
[ISO 9000, definition 3.2.6]
3.17
top management
person or group of people who directs and controls an organization at the highest level
[ISO 9000, definition 3.2.7]
3.18
review
activity undertaken to determine the suitability, adequacy and effectiveness of the subject
matter to achieve established objectives
NOTE Review can also include the determination of efficiency.
EXAMPLE Management review, design and development review, review of customer requirements and
nonconformity review.
[ISO 9000, definition 3.8.7]
3.19
life cycle
time interval between a product’s conception and its disposal
[IEC 60300-3-3, definition 3.1]

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SIST EN 60300-2:2004
60300-2 © IEC:2004 – 19 –
4 Dependability management system
The dependability management system is part of the overall management system of an
organization. It provides an organizational framework for strategic direction of dependability
policy, control of dependability functions and coordination of all dependability activities. Early
attention to dependability plans and allocation of appropriate resources is needed for tailoring
of effort to achieve the desired dependability objectives. To ensure dependability of a product,
it is essential that reliability and maintainability are designed into the product and verified for
their acceptance at various stages of the product realization process. Appropriate
maintenance support effort is needed to sustain dependability in product applications, where
available technology does not allow failure-free life cycles.
The dependability management system should provide a product life cycle framework for
implementation of appropriate dependability programmes (see 3.3, Note 2) to meet the
organization’s business objectives, including customer satisfaction. The product life cycle
reflects an end-to-end process; from product inception through development and operation to
its end-of-life or withdrawal from use. The life cycle process provides a useful framework to
group related dependability programme elements and tasks.
The process steps for managing dependability are presented in the top-level dependability
management standard IEC 60300-1. They include:
– defining dependability objectives;
– analysis of the scope of dependability work needed and implications;
– planning strategy and activities to achieve dependability objectives;
– implementation of selected dependability tasks;
– analysis of results of dependability tasks implemented;
– evaluation of achieved dependability results for further improvement.
A typical process flow diagram is shown in Figure 1. The applicable dependability standards
associated with each process step are presented in Annex D.
Define dependability
1.
objectives
Analyse scope of dependability
2.
work needed and impl
...

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