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
Adopting and referencing IEC International
Standards, their use in regulation, and the
influence of the WTO
A model of a WTO-compliant regulatory system
ISO/IEC Guide 21 rules for adopting
International Standards
Interactions with regulators
2
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 as
national standards
3
Technical regulations are needed to support policies of
governments, 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 the
use of standards
4
Technical regulations are established and administered by a
variety 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 usually
arent technical experts!
5
National technical regulations, conformity assessment procedures
and standards should not constitute unnecessary barriers to
international 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, as
the basis for national regulations and conformity assessment
procedures (there are some exceptions to this )
Play a full part, within the limits of resources, in preparing IS, guides
and recommendations
For example by taking part in IEC Technical Committees!
6
Free market system The theory:
Bad products or unsafe services (not fit for purpose, not
conforming to standards) automatically rejected by
knowledgeable 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!
7
Free market system The reality:
For most products or services the system works well
Competition and price pressure can lead to lower quality in
the long run
Question: What happens when quality comes down to levels
of fitness for purpose?
Answer: Low cost, low quality producers gain market share,
but price pressure continues
Therefore the temptation exists for producers to start to
supply sub-standard products/services to stay in business
Not everyone is so happy any more
8
In many societies, consumers are not well informed, and
have little control over what is on the market
International Standards are part of the answer, but a
standards and quality culture needs to exist
Governments cannot be expected to predict where all
quality problems will arise; market surveillance is
therefore 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
9
When health and safety, or the environment are affected,
the free market system breaks down, and the population
becomes vocal:





Governments therefore need to act decisively
Put in place a technical regulation system
10
Yes, especially where trade with other members is
affected
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
11


12
A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /
Standards
Conformity
Assessment
Sanctions
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 its
territory
Although it has to respect its commitments under
international agreements
13


14
A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /
Standards
Conformity
Assessment
Sanctions
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 or
conformity assessment bodies
Implications for governance structure
15


16
A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /
Standards
Conformity
Assessment
Sanctions
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
17
WTO recommends
The use of relevant International Standards
as a basis for their technical regulations,
except
when such International Standards
would be ineffective or inappropriate
for instance because of fundamental
climatic or geographical factors or
fundamental technological problems
18


19
A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /
Standards
Conformity
Assessment
Sanctions
Conformity assessment is a mechanism that can be used
to 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 industry
needs via 3 Conformity Assessment Systems
For further information on IEC Conformity Assessment,
contact the IEC Central Office, or visit
http://www.iec.ch/conformity
20
IECEE
System of Conformity
Assessment Schemes for
Electrotechnical Equipment
and Components
IECEx
System for Certification to
Standards Relating to
Equipment for use in
Explosive Atmospheres
IECQ
Quality 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
Processes
HSPM
Avionics
21
Obligations of WTO members:
Use a standards and regulatory development process
that is open, transparent, and includes participants from
all interested parties
Have a conformity assessment system that upholds the
principles of most-favoured nation treatment and
national treatment
Publish proposed technical regulations and conformity
assessment procedures
22
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 Multilateral
Agreements
Define market surveillance as part of the ISO/IEC product
certification system 5
3rd party CA and SDOCs
Respect WTO rules
Non-discrimination
Transparency
No more trade restrictive than necessary
23


24
A model of a technical regulatory system
Government
Legislation
Regulator
Technical
regulations /
Standards
Conformity
Assessment
Sanctions
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 need
for unnecessary regulation)
25
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
26
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 by
national law
There would be no easy
mechanism 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
Already exists
Will be updated automatically
Reflects state of the art, international consensus
Cheap, quick, easy to use
Avoids lengthy process of drafting a new
standard that is unrecognized and could just be
reinventing the wheel
28
Might not always be the best technical solution
for the circumstances (but beware of creating
a unique standard that no one wants to follow)
Current technology in the country is not yet at the
right level ( but if you wait, what will be the
situation in 1, 2, 5 years time?)
There might be a political imperative to use a
regional standard (e.g. EN Standards but will
there soon be harmonization with IS anyway?)
29
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
30
Provides methods to adopt
Defines a system for indicating
correspondence
Promotes coherence in the way you adopt
Greater uniformity when indicating deviations
Helps communication avoids confusion
(trade)
31
The publication of a regional or national normative
document

Based on an
I nt er nat i onal
Standard

Has the same status as a national standard or other
normative document

Can have deviations

32
When:

Identical in technical content, structure & wording

It is an identical translation

Minimal editorial changes

The vice versa principle is fulfilled
33
When:

Deviations are identified & explained.

The national standard reflects the structure.

Changes to the structure are permitted

if an easy comparison is possible.
34
When the regional or national standard:

contains less than
contains more than
changes parts of
provides an alternative choice to

the IEC International Standard.

35
For transparency & traceability:

Adopt one IS as one national standard

If, however, several ISs are adopted in one national
standard

Provide an easy comparison of the content
36
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!

37
NOTE Under the IEC Affiliate Country Programme, only identical
adoptions are possible.
Degrees: Identical Modified Not equivalent
Adoption: Yes Yes No
Identifiers: IDT MOD NEQ
38
ANY technical deviations NOT Identical (MOD)
The nature of the deviations and the rationale should be
given 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 foreword
may be added, but the IEC foreword shall remain.
39
Endorsement method:
notice stating the publication has the status of a national
or regional standard
Re-publication:
reprinting
translation
redrafting
40
The National Standards Body issues an endorsement
notice:
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
41
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
42
Based on the International Standard:
Bilingual or monolingual form
Introduction or foreword usually included
Where declared identical the vice versa principle
applies
Consider binding the original with the translation
Bilingual editions - state the validity of the translation
43
Not recommended!
Important technical deviations may be overlooked
Comparison is difficult
Degree of correspondence is difficult to check
44
Member Countries should, as the first and preferred option,
consider adopting the relevant IS when preparing new national
standards or revising existing standards
Harmonization of the existing national standards and adoption of
IS into new national standards should be based on the ISO/IEC
Guide 21
Whenever modifications of content and structure of the relevant
International Standards are necessary to fulfill legitimate
objectives, Member countries should ensure an easy comparison
of the content and structure of their national standards with the
referenced International Standards and provide information to
explain the reason for such modifications while avoiding the
creation of any unnecessary technical barrier to trade
45
If a technical regulation is foreseen, get regulators
involved 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 published
standard

46
National TC secretariats need to keep watch on
international 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 of
dispute
IEC Members and Affiliates have to report to IEC Central
Office (For updating of the IEC adoption database)
47
1. The regional or national standards should include:

an explanation in a regional or national introduction, preface or
foreword and, where appropriate

An annex describing any editorial changes and/or technical
deviations 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) or
editorial changes are few, they may be placed in the
regional or national introduction, preface or foreword

48
3. If included within the text, any regional or national
explanatory notes, editorial changes and/or technical
deviations made with reference to the International
Standard should be clearly highlighted in the text, for
example by inclusion in a box immediately following
the clause to which they relate, or by a single vertical
bar in the margin, or dotted underlining of the
applicable text
4. They should be introduced by the following titles:
regional or national explanatory note or regional or national
explanation if their content is limited to editorial changes, and/or
regional or national deviation if their content is not limited to
editorial changes
49
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 are
then collected together in an annex at the end of the
document. Each variation is cross-referenced to the clause,
etc. of the International Standard, usually with normative
deviations in one annex, together with reasons for the
deviations, and informative notes and guidance in another

50
6. Often, when adopting an International Standard, there
are 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 of
the document. The changed text should be indicated in the main
body of the standard by double marginal bars (||)
This also has the advantage of distinguishing regional or
national requirements (single bars or dotted underlining) from
the international changes

51
National technical Committee No. xyz Transformers has
approved the adoption of IEC 61558-2-16:yyyy as a
national standard .

EITHER: with no technical deviations

OR: with the following technical deviations:
<list>
<list>
52
Sample extract:
In subclause 5.2, the permissible length of the fixing bolts has been
changed 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
53
1. If an adopted International Standard makes normative
reference to other International Standards:
the references should be left unchanged within the text,
regardless of the validity of those standards in the regional or
national adoption, or their status as regional or national
standards
If other documents have to be substituted for those originally
referenced, they should be identified in a regional or national
note. This is most conveniently done in the regional or national
introduction, preface or foreword


54
2. If the referenced International Standards have been
adopted as regional or national standards, this should be
stated in the regional or national introduction, preface or
foreword, 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 in
the introduction, preface or foreword showing the reference
numbers of the corresponding standards and their degree of
correspondence. The referenced documents should be quoted
exactly as they appear in the International Standard
55
3. If some of the referenced International Standards have not
been adopted as regional or national standards in the
region or country, then the regional or national
introduction, preface or foreword should:
Identify the documents that are to be considered valid in their
stead, if reference to the International Standard is not considered
appropriate
Give also information regarding any technical deviations in the
regional 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, the
referencing standard is considered to contain a technical deviation
and, therefore, to have modified correspondence
56
When adoptions are identical
It should be evident immediately
Two options
Single numbering
Dual numbering
57
Example: identical adoption of IEC 60669
The acronym for the regional or national standard body is
added
ABC IEC 60669:1998

Note: Single numbering is recommended for Affiliates

58
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
59
Modified adoptions shall only carry a national number & shall
not include the reference number of the adopted International
Standard
60
Only important for identical:
Option 1: Dating based on the year of publication of the
national standard:

EXAMPLE XYZ IEC 60335:1998 (for an identical adoption of
IEC 60335:1996)

Option 2: Dating based on the year of publication of the
International Standard:
EXAMPLE XYZ IEC 60335:1996 (for an identical adoption of
IEC 60335:1996)
61
Adoption of International Deliverables of IEC other than International
Standards as regional or national deliverables

Adoption of other deliverables than IS often includes a change in the
type 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: Possibility of type-changes

NOTE Under the terms of the Affiliate Country Programme, only IEC
International Standards and Technical Reports may be adopted free of
charge.
62
International Standards shall only be adopted as
regional or national standards and not by a deliverable
of another type than a standard
International Deliverables other than International
Standards (TS, PAS, guides, technical reports) may be
adopted either through an identical regional or national
deliverable or through another type of deliverable
63
The adoption process
Input Output Process Adoption rules
Int. Deliverables:

IS


TS
PAS
TR
Guide
etc.

Nat/Reg.
Deliverables:

NS/RS

Other
national
or regional
deliverables
64
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 to
adopt up to 200 IEC International Standards as national standards
free
Adoptions under the IEC Affiliate Country Programme are in
accordance with ISO/IEC Guide 21-1
Affiliates are required to make a declaration that:

The adoptions of IEC International Standards have been made in
accordance with ISO/IEC Guide 21 AND the Affiliate Adoption Procedure
As such, under national law, such standards may be referred to in
national laws or regulations
Any translations have been done accurately

65
66
For IEC National Committees: IEC Publications in MS
Word format for national adoption

Visit IEC website: http://std.iec.ch/iec-lib/revisablefile.nsf/
welcome?readform
Contact Central Office: Technical Information Support and
Services tiss@iec.ch

For IEC Affiliates:

Visit Affiliate website on national adoption:

http://www.iec.ch/affiliates/adoptions/procedure.htm

Contact Affiliate Secretariat: affiliates@iec.ch
67
Sales policy clause 5
The inclusion of the text of International Standards in full or in part in
national 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 IEC
PDF files should be subject to a royalty of 0% of IEC Catalogue
Price and 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 no
rights to sell the free copies they receive but may use them for
internal purposes.
68
Legal systems differ
The important aspect is the effect of the regulation
Can refer to a whole standard or to just one of its
provisions
Best practice requires that products, services, etc. conform
to relevant provisions of the standard
State the circumstances when conformance is required
(e.g. when used, when sold, when tested )
69
Early cooperation between regulator and standards
developers renders the standards more suitable for use
in 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

70
IEC/CISPR (International special committee on radio interference)
Covers the protection of radio services and promotes international
agreements 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 television
broadcasting receivers and information technology equipment
Membership: radio regulatory authorities, test houses, manufacturers,
numerous IEC and ISO committee liaisons, international organizations such
as 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 in
some form to ensure that products have emissions at acceptable levels
Almost all CISPR standards are embodied in some form in national
legislation in many of the worlds major markets
71
IS have broad geographical reach (Global relevance
policy)
IS are developed by experts in a multi-stakeholder
environment
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

72
Developing countries need to better influence IS
Need to kick-start economies and make improvements
in 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 developed
from within
73