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Adopting and referencing IEC International
Standards for use in technical regulations
Abridged course for IEC National Committees
and Affiliate Countries
by
Graham Holloway
Independent consultant
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Adopting and referencing IEC InternationalStandards, their use in regulation, and theinfluence of the WTO
A model of a WTO-compliant regulatory system
ISO/IEC Guide 21 rules for adopting
International Standards Interactions with regulators
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IS can be adopted By companies, consortia Nationally Regionally
IS can be referred to In company procedures, marketing literature In other standards (national, regional, international) In technical regulations
In some countries IS can be used directly
In others, they may not be used unless first adopted asnational standards
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Technical regulations are needed to support policies ofgovernments, regulators at all levels
Q: How much regulation is necessary?
Q: Shouldnt everything be regulated?
Market system and when it breaks down
Technical regulations are MANDATORY (Compulsory)
Technical regulations contain technical and administrative provisions
The technical provisions can most conveniently be provided by theuse of standards
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Technical regulations are established and administered by avariety of bodies, often in the public sector
Need is to adopt or refer to IS within a technical regulation but how?
What about the WTO Agreements?
Most research is done in the private sector
Need for consensus of EXPERTS (BUT the regulator has
the right to set regulations WITHOUT expert opinion!) Need to update regularly
Technical regulations are legal documents, but lawyers usuallyarent technical experts!
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National technical regulations, conformity assessment proceduresand standards should not constitute unnecessary barriers tointernational trade (CA includes inspection, testing, certification )
Need for balance between Members legitimate right to regulate; and Threat posed by unnecessary TBTs
Use IS, guides and recommendations, or relevant parts of them, asthe basis for national regulations and conformity assessmentprocedures (there are some exceptions to this )
Play a full part, within the limits of resources, in preparing IS, guidesand recommendations
For example by taking part in IEC Technical Committees!
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Free market system The theory:
Bad products or unsafe services (not fit for purpose, notconforming to standards) automatically rejected byknowledgeable consumers
Market advantage for producers of good products/services No incentive to produce bad or unsafe products
Product standards and quality systems play a role
Competition in all markets
Prices forced down by healthy competition Only efficient producers survive (economies of scale)
Everybody is happy!
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Free market system The reality:
For most products or services the system works well
Competition and price pressure can lead to lower quality inthe long run
Question: What happens when quality comes down to levelsof fitness for purpose?
Answer: Low cost, low quality producers gain market share,but price pressure continues
Therefore the temptation exists for producers to start tosupply sub-standard products/services to stay in business
Not everyone is so happy any more
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In many societies, consumers are not well informed, andhave little control over what is on the market
International Standards are part of the answer, but astandards and quality culture needs to exist
Governments cannot be expected to predict where allquality problems will arise; market surveillance istherefore lacking
Even if conformity assessment providers (test labs,
certification bodies etc.) exist There is need to be laws to prevent bad (unsafe,
poisonous, damaging ) products from being sold
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When health and safety, or the environment are affected,the free market system breaks down, and the populationbecomes vocal:
Governments therefore need to act decisively
Put in place a technical regulation system
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Yes, especially where trade with other members isaffected
Notifications have to be made of all proposed technical
regulations BUT: where urgent problems arise or threaten to arise:
Safety, health, environmental protection, national security even the quality of exports:
Certain steps may be relaxed or omitted They still have to be notified later
There are other relaxations for developing countries
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A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /Standards
ConformityAssessment Sanctions
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Applies to all levels of government:
National, provincial (state), municipal
Covers products, services and actions
For which compulsory provisions are needed
Over and above the free market system
Private contracts are not regulations
National government is the supreme regulator in itsterritory
Although it has to respect its commitments underinternational agreements
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A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /Standards
ConformityAssessment Sanctions
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Must be established by law
Must be a legal persona juristic person in the country
Powers must be made known (and their limitations)
Should not have conflicts of interest with standards orconformity assessment bodies
Implications for governance structure
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A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /Standards
ConformityAssessment Sanctions
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Regulator sets the regulations
Public enquiry
Impact assessment
Backed by government
Need to include
Specific purpose, scope, who is affected
Technical provisions that are to be complied with Administrative provisions: Rules for provision of samples,
conformity assessment, costs, sanctions
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WTO recommends
The use of relevant International Standardsas a basis for their technical regulations,except
when such International Standardswould be ineffective or inappropriate
for instance because of fundamental
climatic or geographical factors orfundamental technological problems
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A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /Standards
ConformityAssessment Sanctions
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Conformity assessment is a mechanism that can be usedto assess compliance with standards
Conformity assessment is a separate subject in itself,and its application differs from sector to sector
In electrotechnology, IEC has responded to industryneeds via 3 Conformity Assessment Systems
For further information on IEC Conformity Assessment,contact the IEC Central Office, or visithttp://www.iec.ch/conformity
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IECEESystem of Conformity
Assessment Schemes for
Electrotechnical Equipment
and Components
IECExSystem for Certifi cation to
Standards Relating to
Equipment for use in
Explosive Atmospheres
IECQQuality Assessment System
for Electronic Components
CAB - Conformity Assessment Board
CB-FCS
Scheme
CB Scheme
PV Programme
E3 Energy
Efficiency
Hazardous
Substances
Ex Equipment
Ex Services
Ex Personnel
Active &Passive
components
ProcessesHSPM
Avionics
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Obligations of WTO members:
Use a standards and regulatory development processthat is open, transparent, and includes participants from
all interested parties Have a conformity assessment system that upholds the
principles of most-favoured nation treatment andnational treatment
Publish proposed technical regulations and conformityassessment procedures
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Based on International Standards, e.g. ISO/IEC 17025,Guide 65 (soon to be ISO/IEC 17065, ISO/IEC 17020,etc.)
Use accredited service providers and IEC CA Systems
Mutual Recognition Agreements and MultilateralAgreements
Define market surveillance as part of the ISO/IEC productcertification system 5
3rd party CA and SDOCs
Respect WTO rules
Non-discrimination
Transparency
No more trade restrictive than necessary 23
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A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /Standards
ConformityAssessment Sanctions
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Regulators powers are defined
Entry of premises, samples, confiscation, disposal
Fines
Suspension, prohibition of trading
but necessary to avoid protectionism
Regional context (harmonization, FTAs reduce the needfor unnecessary regulation)
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No perfect solution for all countries
Different levels of governmental control,consumer pressure, conformity assessment
WTO Compliance - OECD Recommendations: Transparent
Accountable
Proportionate to risk
Consistent
Targeted only where action is needed
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No obligation to adopt an International Standard You could just leave it for interested parties to use as it
is
BUT:
This might not be allowed bynational law
There would be no easymechanism for clearly indicating(or changing) any national
deviations Possible legal challenges
They have a Standards Body / TC, so why was it not recognized
as a national standard ?
The Endorsement method = an adoption 27
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Already exists
Will be updated automatically
Reflects state of the art, international consensus Cheap, quick, easy to use
Avoids lengthy process of drafting a newstandard that is unrecognized and could just be
reinventing the wheel
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Might not always be the best technical solutionfor the circumstances (but beware of creatinga unique standard that no one wants to follow)
Current technology in the country is not yet at theright level ( but if you wait, what will be thesituation in 1, 2, 5 years time?)
There might be a political imperative to use a
regional standard (e.g. EN Standards but willthere soon be harmonization with IS anyway?)
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ISO/IEC Guide 21:2005
Regional or national adoption of International Standards
Part 1: Adoption of International Standards
Part 2: Adoption of International Deliverables other than International
Standards
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Provides methods to adopt
Defines a system for indicatingcorrespondence
Promotes coherence in the way you adopt
Greater uniformity when indicating deviations
Helps communication avoids confusion(trade)
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The publication of a regional or national normativedocument
Based on an International Standard
Has the same status as a national standard or othernormative document
Can have deviations
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When:
Identical in technical content, structure & wording
It is an identical translation
Minimal editorial changes
The vice versa principle is fulfilled
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When:
Deviations are identified & explained.
The national standard reflects the structure.
Changes to the structure are permitted
if an easy comparison is possible.
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When the regional or national standard:
contains less than
contains more than
changes parts of
provides an alternative choice to
the IEC International Standard.
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For transparency & traceability:
Adopt one IS as one national standard
If, however, several ISs are adopted in one nationalstandard
Provide an easy comparison of the content
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A national standard is considered not equivalent:
When it is not equivalent in technical content
When changes have not been clearly identified
Where only a minority of the international provisions remain
This is not really an adoption!
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NOTE Under the IEC Affiliate Country Programme, only identicaladoptions are possible.
Degrees: Identical Modif ied Not equivalent
Adoption: Yes Yes No
Identifiers: IDT MOD NEQ
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ANY technical deviationsNOT Identical (MOD)
The nature of the deviations and the rationale should begiven in a national (or regional) foreword
If the changes are not clearly identified
the national or regional standard is NOT Equivalent(NEQ) to the International Standard
NOTE: Under the IEC Affiliate Country Programme, a national forewordmay be added, but the IEC foreword shall remain.
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Endorsement method:
notice stating the publication has the status of a nationalor regional standard
Re-publication:
reprinting
translation
redrafting
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The National Standards Body issues an endorsementnotice:
Stating the IS has the status of national standard
Referring to only one international publication
Allocating a unique reference number to each endorsement
Using the reference number of the IS
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Print as national standard by direct reproduction:
May include some additional content e.g.
Foreword, introduction
A translation
A different cover page / title
Amendments (to the international publication)
Editorial changes or technical deviations
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Based on the International Standard:
Bilingual or monolingual form
Introduction or foreword usually included
Where declared identical the vice versa principleapplies
Consider binding the original with the translation
Bilingual editions - state the validity of the translation
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Not recommended!
Important technical deviations may be overlooked
Comparison is difficult
Degree of correspondence is difficult to check
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Member Countries should, as the first and preferred option,consider adopting the relevant IS when preparing new nationalstandards or revising existing standards
Harmonization of the existing national standards and adoption of
IS into new national standards should be based on the ISO/IECGuide 21
Whenever modifications of content and structure of the relevantInternational Standards are necessary to fulfill legitimateobjectives, Member countries should ensure an easy comparison
of the content and structure of their national standards with thereferenced International Standards and provide information toexplain the reason for such modifications while avoiding thecreation of any unnecessary technical barrier to trade
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If a technical regulation is foreseen, get regulatorsinvolved early
Regulators have a right to participate
Language used can facilitate or make regulation difficult Standards development process doesnt change
Consensus
Public enquiry
Appeals
Regulators can always use an existing publishedstandard
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National TC secretariats need to keep watch oninternational activities and propose TC actions
Database of dates of approval of different versions
Dates of entry into force as technical regulations
Need to keep historical records and standards in case ofdispute
IEC Members and Affiliates have to report to IEC CentralOffice (For updating of the IEC adoption database)
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1. The regional or national standards should include:
an explanation in a regional or national introduction, preface orforeword and, where appropriate
An annex describing any editorial changes and/or technicaldeviations which have been made, why they have been made,and how they are identified in the text
2. Where technical deviations (and reasons for them) oreditorial changes are few, they may be placed in theregional or national introduction, preface or foreword
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3. If included within the text, any regional or nationalexplanatory notes, editorial changes and/or technicaldeviations made with reference to the InternationalStandard should be clearly highlighted in the text, for
example by inclusion in a box immediately fol lowingthe clause to which they relate, or by a single verticalbar in the margin, or dotted underlining of the
applicable text
4. They should be introduced by the following titles: regional or national explanatory noteorregional or national
explanation if their content is limited to editorial changes, and/or
regional or national deviation if their content is not limited toeditorial changes
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5.An alternative method of indicating explanatory notes,editorial changes or technical deviations, is to:
Use a single vertical bar (|) in the margin, or dotted
underlining, to indicate the applicable text of the International
Standard which is to be changed, and
The regional or national notes, changes and/or deviations arethen collected together in an annex at the end of thedocument. Each variation is cross-referenced to the clause,etc. of the International Standard, usually with normativedeviations in one annex, together with reasons for thedeviations, and informative notes and guidance in another
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6. Often, when adopting an International Standard, thereare amendments and/or technical corrigenda:
These may be incorporated into the text, or the amendments
and/or technical corrigenda may be bound together at the end ofthe document. The changed text should be indicated in the mainbody of the standard by double marginal bars (||)
This also has the advantage of distinguishing regional ornational requirements (single bars or dotted underlining) from
the international changes
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National technical Committee No. xyz Transformers hasapproved the adoption of IEC 61558-2-16:yyyyas a
national standard .
EITHER:with no technical deviations
OR:with the following technical deviations:
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Sample extract:
In subclause 5.2, the permissible length of the fixing bolts has beenchanged from 19-21 mm to 18-22 mm to allow for local production
capabilities. This will be kept under review by the Technical
Committee.
Important: National deviations do not have to be permanent!
Deviations can be added or removed by means of an amendment
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1. If an adopted International Standard makes normativereference to other International Standards:
the references should be left unchanged within the text,
regardless of the validity of those standards in the regional ornational adoption, or their status as regional or nationalstandards
If other documents have to be substituted for those originallyreferenced, they should be identified in a regional or nationalnote. This is most conveniently done in the regional or nationalintroduction, preface or foreword
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2. If the referenced International Standards have beenadopted as regional or national standards, this should bestated in the regional or national introduction, preface orforeword, and their regional or national reference
numbers should be given
Similarly, where there are no valid regional or national documents,this should also be indicated
A convenient method of indicating these relationships is a list inthe introduction, preface or foreword showing the referencenumbers of the corresponding standards and their degree ofcorrespondence. The referenced documents should be quotedexactly as they appear in the International Standard
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3. If some of the referenced International Standards have notbeen adopted as regional or national standards in theregion or country, then the regional or nationalintroduction, preface or foreword should:
Identify the documents that are to be considered valid in theirstead, if reference to the International Standard is not consideredappropriate
Give also information regarding any technical deviations in theregional or national documents from the International Standards
replaced by them When a document other than an identical regional or national
standard is substituted for a referenced International Standard, thereferencing standard is considered to contain a technical deviationand, therefore, to have modified correspondence
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When adoptions are identical
It should be evident immediately
Two options
Single numbering
Dual numbering
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Example: identical adoption of IEC 60669
The acronym for the regional or national standard body isadded
ABC IEC 60669:1998
Note: Single numbering is recommended for Affiliates
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Example: an identical adoption of IEC 60669
The number is composed of two individual numbers
The adoption number is followed by the original number
of the International Standard:
ABC 23429:1998 IEC 60669:1996
or
ABC 23429:1998
IEC 60669:1996
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Modified adoptionsshall only carry a national number & shallnot include the reference number of the adopted International
Standard
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Only important for identical:
Option 1: Dating based on the year of publication of thenational standard:
EXAMPLE XYZ IEC 60335:1998 (for an identical adoption ofIEC 60335:1996)
Option 2: Dating based on the year of publication of theInternational Standard:
EXAMPLE XYZ IEC 60335:1996 (for an identical adoption ofIEC 60335:1996)
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Adoption of International Deliverables of IEC other than InternationalStandardsas regional or national deliverables
Adoption of other deliverables than IS often includes a change in thetype of deliverable(e.g. IEC/PAS adopted as a national standard)
Main difference between the 1999 and the new edition:
2nd edition adoption: Identicality of the type of deliverable
3rd edition adoption: Possibil ity of type-changes
NOTE Under the terms of the Affiliate Country Programme, only IECInternational Standards and Technical Reports may be adopted free ofcharge.
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International Standardsshall only be adopted asregional or national standardsand not by a deliverableof another type than a standard
International Deliverables other than InternationalStandards(TS, PAS, guides, technical reports) may beadopted either through an identical regional or national
deliverable or through another type of deliverable
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The adoption process
Input OutputProcess Adoption rules
Int. Deliverables:
IS
TS
PAS
TR
Guide
etc.
Nat/Reg.
Deliverables:
NS/RS
Other
national
orregional
deliverables
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In IEC, there is a database of adopted IEC International Standards
Members have to feed in their adoption data directly
Participants in the IEC Affiliate Country Programme are entitled toadopt up to 200 IEC International Standards as national standards
free
Adoptions under the IEC Affiliate Country Programme are inaccordance with ISO/IEC Guide 21-1
Affiliates are required to make a declaration that:
The adoptions of IEC International Standards have been made inaccordance with ISO/IEC Guide 21 AND the Affiliate Adoption Procedure
As such, under national law, such standards may be referred to innational laws or regulations
Any translations have been done accurately
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For IEC National Committees: IEC Publications in MSWord format for national adoption
Visit IEC website: http://std.iec.ch/iec-lib/revisablefile.nsf/welcome?readform
Contact Central Office: Technical Information Support andServices [email protected]
For IEC Affiliates:
Visit Affiliate website on national adoption:
http://www.iec.ch/affiliates/adoptions/procedure.htm
Contact Affiliate Secretariat: [email protected]
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Sales policy clause 5The inclusion of the text of International Standards in full or in part innational standards, is permitted in accordance with ISO/IEC Guide
21-1 (2005)
According to CB Decision 2001/008:
"... sales of those national standards which contain the original IECPDF files should be subject to a royalty of 0% of IEC Catalogue
Priceand a detailed report on the sale of all those specific national
standards will be submitted to the CO on a quarterly basis."
NOTE 1 The IEC sales policy on national adoptions applies to both
the endorsement and republication methods (including translations).
NOTE 2 The policy applies to IEC Full and Associate Members.Affiliates fall under the Affiliate adoption procedure they have norights to sell the free copies they receive but may use them forinternal purposes.
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Legal systems differ
The important aspect is the effect of the regulation
Can refer to a whole standard or to just one of itsprovisions
Best practice requires that products, services, etc. conformto relevant provisions of the standard
State the circumstances when conformance is required(e.g. when used, when sold, when tested )
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Early cooperation between regulator and standardsdevelopers renders the standards more suitable for usein regulation
Early knowledge of the proposed CA regime assists in
the development of the standard Know the clients needs up front
Saving of time and money
Standard is a consensus of expert opinion Better chance of a smooth passage through public
enquiry and industry acceptance
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IEC/CISPR (International special committee on radio interference)
Covers the protection of radio services and promotes internationalagreements on aspects of radio interference
Protection of radio reception from interference sources, such as electrical
appliances of all types, ignition systems, electricity supply systems,industrial, scientific and electromedical radiofrequency, sound and televisionbroadcasting receivers and information technology equipment
Membership: radio regulatory authorities, test houses, manufacturers,numerous IEC and ISO committee liaisons, international organizations suchas the CEPT (European Conference of Postal and Telecommunications)and the ITU (International Telecommunications Union)
The limits used in CISPR product standards are almost universally used insome form to ensure that products have emissions at acceptable levels
Almost all CISPR standards are embodied in some form in nationallegislation in many of the worlds major markets
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IS have broad geographical reach (Global relevancepolicy)
IS are developed by experts in a multi-stakeholderenvironment
IS are WTO-TBT compliant
IS can be updated more easily than technical regulations
Adoption of IS is easy, quick and cheap
IS facilitate regulatory compliance IS facilitate growth in market access for developing
economies
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Developing countries need to better influence IS
Need to kick-start economies and make improvementsin quality infrastructure
Improved market access does not come overnight Developed countries are still competing
WTO agreements are still causing division
Consumerism and quality culture have to be developedfrom within