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What is the difference
between an ISO, EN-ISO and
BS-EN-ISO Standard?
We often get asked this simple question: What is the difference
between an ISO, EN-ISO and BS-EN-ISO Standard? The simple
answer is Not much. But theres more to it than that.
Ive talked about this in a previous blog, but since the question
still crops up with much frequency, Im going to address the
question again.
There are three issues at play in answering the question: 1.
Location, 2. Adoption, and 3. Certification.
1. Location:
An ISO document is developed as an international standard. It is
intended to have world-wide usage. It is written under strict
protocols with participation from delegates from all over the
world. Once released, it is publicly available for distribution.
An EN document is developed as a regional standard. It is
intended to be used in the European Union. It is written under
protocols with participation from delegates of the member states.
Once released, it is not available for public distribution.
A BS-EN document (or DIN-EN or AFNOR-EN, etc.) is a national
standard. It is published as each country in Europe adopts the EN
document. There are strict requirements for the withdrawal of
any conflicting or duplicating standards.
2. Adoption:
When an ISO document is released, countries have the right to
republish the standard as a national adoption. So, when the ISO-
14971, for example, is issued, the European Union has the right to
adopt and republish the standard.
When the EU chooses to adopt an ISO standard, they add a level
of administrative overhead. Thus, the EN adoption has a later
issue date than the original ISO document, plus additional cover
sheet information.
Usually, the true title of the EN standard will show you exactly
what revision level of the ISO standard is being adopted. So in
our example of EN-ISO-14971, 2009 Edition, the title is Medical
devices Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01). As you can see, the
complete title shows you what edition of the ISO document has
been adopted.
However, as we noted above, the EN edition when issued is not
actually available for public distribution. Copies in English,
 However, as we noted above, the EN edition when issued is not
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actually available for public distribution. Copies in English,
Entries RSS French and German are supplied to each member of the EU.
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The British Standards Institute publishes the official English
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language edition (in this case, BS-EN-ISO-14971), the German
Standards Institute (DIN) publishes the official German language
edition, and the French (AFNOR) publish the official French
SIGNUPBELOW!
language edition. The issue dates on each of these national
Join Our Monthly Newsletter adoptions will differ as the administrative time to review
and Get Your Free PDF Copy of national standards for possible withdrawal varies.
ASME's BPVC Changes for The
2017 Editions!
Email 3. Certification:

First Name As we have seen, we have a core ISO document that becomes
increasing wrapped in layers of administrative adoption
Last Name processes. While our first impulse would be to go to the source
document, I encourage you to take a moment to consider the
political undercurrents involved.
IWANTMYFREEPDF!

Because the EN editions of all standards are called out in the

European Unions regulatory schema (the European Directives
AUTHORCLAUDIABACH, harmonization process), many certification professionals will
PRESIDENT,DOCUMENT
only accept EN standards when reviewing customer facilities and
CENTERINC.
practices. Additionally, the EN editions have the Z Annexes,
Google which do have an impact on your understanding of how the
clauses in an individual harmonized standard relate to the
relevant Directive.

So if you know that your trading partner in the European Union

is in Germany and they want your auditor to come from a
German firm, you may be well advised to get the English
language editions of the DIN-EN standards where ever possible.

And if you are going to be audited by a firm based in England,

like BSI for example, you should definitely consider purchasing
the BS-EN editions of any ISO standard you use. This can save
you much time during your audit, even though it costs
significantly more when you purchase the standard itself.

So, in conclusion, ISO, EN-ISO, and BS-EN-ISO documents all

contain the same core information. Only the administrative
wrapping changes with each subsequent adoption level.

I hope this helps you understand this complex issue!

Let me know if you have any questions. I can be reached by

phone (650-591-7600), fax (650-591-7617) or email
(info@document-center.com). Or my expert staff can easily help
you out.

PUBLISHEDBY

Claudia Bach
Claudia Bach is the President of Document Center Inc. and a world-wide
recognized expert on Standards and Standards Distribution. You can
connect with her on Google+ View all posts by Claudia Bach
 September9,2011 ClaudiaBach GeneralStandardsQuestions

28 thoughts on What is the difference between an

ISO, EN-ISO and BS-EN-ISO Standard?

Utsav
September26,2013at10:39pm

Dear mam,

I would thank you very much for above information which is

satisfactory upto much extent.

As per above answer it seems that content will be unaltered but

whether it is always so or there can be addition or modification
sometimes, would you please let us know?

Claudia Bach
September27,2013at8:41am

Thanks so much for asking.

The situation is this When an ISO standard is adopted, it is
adopted as written. When an IEC standard is adopted it usually is
adopted as written. However, because of the national variations
in the use of electricity, there may be some variation.
In addition, the rules of the EU require each nation to review
their standards prior to the adoption and publication of each EN
10 standard. These rules require that any duplicate or conflicting
standards be withdrawn in favor of the EN edition.
You may find administrative information from the specific
country that is publishing the standard in the cover sheet. This
information (depending on the country) may offer insight into
the documents that have been affected by the adoption and
publication of the EN edition youre using.
I hope this is helpful to you.
Best regards,
49
Claudia

Dirk van Putten

December5,2013at11:17am

Hello Document Center:

Can you improve each documents description on your website

with full explanations of their titles? For EN-ISO-14971, why not
list it as European Union regional standard (EN), English
Language, of ISO 14971:2009? Why not make it as easy as possible
for customers to to find and buy standards?
 Claudia Bach
December6,2013at8:54am

Hi Dirk:
Thank you so much for asking about this.

Your idea is a great one! I always think of the problem of the

various adoptions and republications as strictly an educational
issue Customers are not aware of the policies of the various
standards organizations so this proliferation of document
numbers is confusing.

But I have not thought about actually providing an explanation

of the situation in the results page on our site.

It may take us a while to implement your idea, but we certainly

will as it will make it much easier for folks to identify what copy
they actually need to order.

Thanks for bringing this to our attention!

Best regards,
Claudia
Document Center Inc.

khalid
February6,2014at5:55am

dear Claudia
thank you for this information

Id like to ask this question in different way,

Is there any relationship between BS and EN? In addition, ISO?

Ill be very thankful if you could give me answer for this.

many thanks

Khalid,

Claudia Bach
February6,2014at9:35am

Thanks for asking.

There is a relationship between BS and EN. The EN organizations

are a regional grouping for the countries that belong to the
European Union. So the 2 EN standards bodies (CEN and
CENELEC) are composed of representatives from each of the
member nations. For the UK, that would be BSI (the organization
that publishes the BS standards).

Since the EN standards are not released to the general public as

just EN standards, it is up to each nation in the EN system to
publish each standard as it is adopted in that country. The official
English language editions of the EN standards are always
published by BSI as BS EN documents.
English language editions of the EN standards are always
published by BSI as BS EN documents.

OK. So far so good!

Now what about ISO? ISO is the International umbrella

organization for standardization. It is made up of representatives
from various countries around the world.

Since one major goal of standardization these days is to bring as

much harmonization into the system as possible (the use of a
single standard worldwide for a specific topic is the ideal), it
makes a lot of sense for as many countries as possible to use ISO
standards.

In order to accomplish this in Europe, the process is for the EN to

adopt an ISO standard. This becomes an EN ISO standard. But
again, it cannot be publicly distributed as such. In comes each
country in Europe with the publication of our EN ISO document
as it is adopted for use. Now we have BS EN ISO standards. They
are the official English Edition of the European Adoption of a
specific ISO standard!

Yipes! And yet, thats the way the system works

Hope this is helpful.

Regards,
Claudia

John
November4,2014at7:44am

Thank you for the explanation. I am teaching design to HNC

Engineering students from both electrical and mechanical
backgrounds. The explanation is simple and makes easy reading.
I will use this in my teaching notes (if you have no objections?).

Claudia Bach
November4,2014at8:27am

Hi John:
I would be delighted to have you include this in your teaching
notes. One of my primary goals in writing this blog is to help
folks understand standards and how theyre properly used. And
one important group for such education is in academia
specifically engineering students.
Thanks so much for thinking of us! And do let me know if theres
other topics youd like to have me post a blog on as well.
Regards,
Claudia

Sukri Ismail
January5,2015at1:44am

Wow, this is as easy as ABC to understand for such a confusing

question.
Tq Claud!
 marco
June1,2015at2:14am

Very nice explanation. I would like make sure that I got your
example right:
So if you know that your trading partner in the European Union
is in Germany and they want your auditor to come from a
German firm, you may be well advised to get the English
language editions of the DIN-EN standards where ever possible.
The English language editions is the one published by The British
Standards Institute and referring to the same EN or is actually the
translation of the official German language edition published by
the DIN.
If I have understood correctly the the English language edition
(by the British Standards institute) and the DIN version, translated
in English may have some differences due to national standards.
Hope I have this right.
Kind Regards,
Marco

Claudia Bach
June1,2015at9:14am

Hi Marco:
And thanks for asking.

So to make it easy on ourselves, here is the situation:

EN provides official copies of all EN Standards to the European

National Standards Bodies in three languages English, French
and German. The official English language copy is published as
a BS EN document, the official French as the AFNOR EN and the
official German as the DIN EN.

All national EN publications can have national cover sheets.

Some National Standards Bodies use those cover sheets to tell you
administrative information like when they process the standard
internally, what other of their standards might have been
withdrawn in favor of the EN and so on.

Each National Standards Body has the right to publish any EN

standard in any of the three language editions that come from
EN. So they can publish that same source EN document in English
as BSI does, for example. They also have the right to publish a
national translation.

Most countries publish one of the three official language copies

rather than going to the trouble of translating. So no matter
where in Europe you get your copy, as long as its one of those
three official language editions, its always the same (with the
exception of the administrative cover sheet material).

I hope this is helpful to you!

Regards,
Claudia

marco
June2,2015at12:22am
June2,2015at12:22am

Claudia,

Very clear. Thank you for the quick reply.

Best,
Marco

Graham
June18,2015at3:35am

Claudia,

Your initial blog explanation and responses to the follow-up

questions are crystal clear. Brilliant. Thank you

I am re-educating myself on security, crisis management and

business continuity standards as I am preparing for job
interviews. Researching the various standards in these areas;
what is the difference was an obvious question, which you
answered comprehensively yet very clearly. Many thanks!

Graham

Claudia Bach
June18,2015at9:06am

Thanks so much, Graham!

Im glad you found this to be of assistance.
Other questions? Let me know. I always welcome the chance to
help people be more effective standards consumers!
Cheers,
Claudia

Sabrina
August18,2015at2:44am

Very nice article Claudia!

I am hoping you can clarify one more thing for me. Since there is
no difference in the core text between the ISO and EN ISO
Standards, do you know if it is a requirement to purchase both
standards if the company is being certified for example to both
EN ISO 13485 and ISO 13485? We already have all applicable BS
EN ISO standards and I think buying the ISO standards would just
be a duplicate since the core text remains unchanged.

Thank you,

Sabrina

Sabrina
August18,2015at6:10am

Great article Claudia! I posted a comment this morning but I

dont see it in the thread so hopefully this wont be a duplicate.
Do you know if a company is required to purchase both the BS EN
dont see it in the thread so hopefully this wont be a duplicate.
Do you know if a company is required to purchase both the BS EN
ISO standards and the ISO standards if the quality management
system is certified to both EN ISO 13485 and ISO 13485? We
currently have all applicable BS EN ISO standards, but I am not
sure if it is also a requirement to buy the ISO standards since the
certification will be for both EN ISO 13485 and ISO 13485.
Since the content of the core text remains unchanged between
the EN ISO and ISO standards, I dont think it would be necessary
to buy both EN ISO and ISO standards but I am not sure if the
notified body would expect us to have duplicates of all standards.
Hopefully you can shed some light.

Thank you,

Sabrina

Claudia Bach
August18,2015at8:33am

Hi Sabrina:
Thanks so much for asking.
My understanding is that Notified Bodies will not accept the ISO
Edition in lieu of the EN ISO Edition. However, for certifying just
to the ISO Edition, there can be many versions to choose from
and any (including the EN ISOs) are acceptable as long as there
are no national exceptions.
I hope this answers your question!
REgards,
Claudia

Seman
September22,2015at6:43pm

Dear Claudia,

My questions to you would be :

1/ BS 8903 talks about sustainable procurement
2/ ISO 20400 also considered the same except one additional
elements included.

Is it possible to state that both Standards are same in terms of

comparing them ? And secondly, why in the UK, they have ISO
and BS separately ? Are they not same ?

Adithyan
January11,2017at5:11am

Dear Claudia,

First of all, Thank you so much for the valuable piece of

information.

While reviewing the technical documents in my organization,

Ive came across similar codes with varying standardization.

BS ISO 7121- Steel ball valves for general-purpose industrial

applications.
BS 7121- Code of practice for safe use of cranes.
applications.
BS 7121- Code of practice for safe use of cranes.

In this case please clarify how should i distinguish these codes

with respect to our discussion or subject.

Claudia Bach
January12,2017at10:18am

Thanks so much for asking, Adithyan:

These are two separate documents.

One is a British Standards series The BS 7121 series on cranes.

Youll find them as BS-7121-1, BS 7121-2, etc. They are British
standards for use in Britain only.

The second is the British adoption of an ISO standard. This item

was originally published as International Standard ISO 7121 on
steel ball valves. When the British reviewed this publication, they
determined that they would like to adopt it as an official British
standard. So because they belong to ISO and helped to write the
standard, they can indeed adopt it. The method by which they
adopt standards is to republish them in full with an
administrative cover sheet. So now you have the BS ISO 7121
which has the British cover sheet and the inclusion of the
original ISO 7121 as the text of the standard.

Having lots of different standards organizations using alpha

numeric designations like this can be confusing. Remember, first
look at the initial alpha component of the number It usually is
an acronym that tells you what organization(s) issued the
document. Then the numeric part tells you what unique
document it is from that organization.

Let me know if you still have questions. And thanks again for
asking!
Regards,
Claudia

Satha A. M.
January12,2017at8:34pm

Hi Claudia

Thank you very much for all the clarification above. Its helped
throw some light into some of the confusion I have been facing.

Could you please help me with the following.

1) You have indicated that the EN standard is released in three

languages to the EN countries, and that once the respective
countries adopt them, they are then commercially available as
say, BS EN 123456, DIN EN 123456. Does that mean that the
standard EN 123456 per se, is not available at all for purchase
by the public?

2) You have indicated that once a country adopts a EN standard, it

may include some minor changes such as (voltage, etc.). Besides
these nuances, are the adopting countries required to adopt the
full context of the EN Standard. I am particularly interested in the
these nuances, are the adopting countries required to adopt the
full context of the EN Standard. I am particularly interested in the
potential variation of EMC test procedures, and EMC immunity
and emission limits are they required to follow the same.

3) Having considered the differences between EN, BS EN, could

you please throw some light on differences with IEC.

Thanks Claudia.
Satha

Claudia Bach
January13,2017at8:42am

Hi again, Satha:
I can easily answer question 1. Any EN is only available in a
national adoption. So all ENs are not available as the source
document given to each of the national bodies. You must
purchase them in a national edition only.

Question 2. Certainly, the technical issues involved in the

adoption of the IEC standards are beyond my technical expertise.
However, it is my understanding that any deviations from the
text of the source document must be notated in the cover sheet
administrative information. I will check in with my sources to
see if I can get you a more definitive answer.

Finally, with regards to testing requirements. I would strongly

suggest that you use a reputable testing lab and follow their
expertise for these issues.

Hope this is helpful!

Best regards,
Claudia

Jonathan Sandler
January27,2017at12:23pm

Hello Claudia,

Thank you for the informative write-up and comments. This has
usually been a source of confusion for me, and apparently others
as well, so I just want to confirm my understanding. Apologies if
this is completely repetitive:

1) ISO standards are international/global and the foundation for

which all subsequent standards of the same number (i.e. 13485,
14971, 62366, etc.) are based.

2) EN ISO standards are the ISO standards specifically adopted for

the European community (whatever those changes might be).
When dealing within Europe, the EN ISO standards supersede the
ISO standards.

3) BS EN ISO is the English language version of the European

standard, DIN EN ISO is the German language version of the
European standard, and so on.

Your confirmation of my understanding or any further

clarification is greatly appreciated.
Your confirmation of my understanding or any further
clarification is greatly appreciated.

Best regards,
Jonathan

Claudia Bach
February7,2017at9:20am

Hi Jonathan:
By Jove, youve got it!

I will note that the reason that the EN ISO are used exclusively in
Europe is that the EN documents are specifically referred to in the
Directives. So when dealing with Europe, as you noted, only the
EN ISOs need apply.

And one further note, even though a DIN EN ISO is the German
language edition, often times it will be published in both
German and English language editions. The English language
edition is identical to any other English language edition
published in Europe, including the BS EN ISO one.

This blog is my most popular posting! I am amazed at how many

people need assistance with this particular topic. Im glad to be of
assistance to you all with this one!

Regards,
Claudia

Deane
February8,2017at8:46pm

Hi Claudia,

Thank you for your great explanation!

I do have a question though.

For instance, ETSI EN 301 489-1 has recently been updated and is
citing EN 61000-4-4:2012 as one of its normative references.

Will a lab be required to purchase the EN 61000-4-4:2012 standard

if it already has IEC 61000-4-4: 2012?

Claudia Bach
February9,2017at9:39am

Hi Deane:
Thank you so much for asking.

I know that CEN and CENELEC (the other 2 European Standards

Bodies) have instituted a mandate to use the EN editions of all
referenced standards (if available)in their publications. So in my
opinion, youll need the EN edition of the 61000-4-4 for ETSI as
well. Please confirm this with your testing lab and certification
body.

One of my staff members and I were just thinking about the

One of my staff members and I were just thinking about the
World Standards Day theme from a decade or so back One
Standard, One Test, Accepted Everywhere. The protocols of
adoption and distribution for the EN standards in particular seem
to make this goal feel more distant than ever!

Regards,
Claudia

Deane
February22,2017at6:26pm

Hi Claudia,

Thank you for your response.

That clears up my confusion about the need for EN version.

That being said, I do have a question relating to standards that

have their status withdrawn. Can we still make use of a
withdrawn standard for reference if that particular standard has
an updated version, say for example, ENxxx: 2004 has been
replaced by ENxxx: 2012?

Best Regards,
Deane

Claudia Bach
February23,2017at9:54am

Hi Deane:
Another good question.

First, some contracts do call out obsolete versions of standards.

This can be for a number of reasons, usually involving
replacement parts. So we do find any number of folks using
obsolete standards at any given time.

However, I think your question is more about transition dates. A

common question is how much time do I have before I have to
move to the new Edition of a standard?

For EN standards that are on a harmonized list (like the

harmonized list of standards for the Medical Device Directive), a
new Edition of a reference standard has to be formally accepted.
This is done by publication in the Official Journal. Once that
happens, the new Edition is put on the harmonized list. And a
Cessation Date is provided. This date is when the old Edition is
no longer valid. You must be compliance with the new edition
after that date.

Many standards are not on the harmonized list. So, sometimes

you need to see what the regulations are in the jurisdictions
youre going to be selling your product. You need to meet the
legal requirements and sometimes that includes specific editions
of a standard.

If there are no specific legal requirements regarding which

edition to use, then it is up to you. I would caution that using out-
dated standards comes with a legal liability. Standards represent
edition to use, then it is up to you. I would caution that using out-
dated standards comes with a legal liability. Standards represent
best practice, using the most up-to-date protocols. This provides
you with a level of protection against lawsuits based on
negligence.

Hope this is helpful!

Regards,
Claudia

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