Din En Iso 14971 Pdf
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 there’s more to it than that. I’ve talked about this in a, but since the question still crops up with much frequency, I’m going to address the question again. There are three issues at play in answering the question: 1. Adoption, and 3. Location: An ISO document is developed as an international standard. It is intended to have world-wide usage.
Jul 31, 2012. View all product details. Language: English. Available Formats; Options; Availability; Priced From ( in USD ). BS EN ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro.
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.
Adoption: When an ISO document is released, countries have the right to republish the standard as a national adoption. So, when the, 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, 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, French and German are supplied to each member of the EU.
The British Standards Institute publishes the official English language edition (in this case, ), the German Standards Institute (DIN) publishes the official German language edition, and the French (AFNOR) publish the official French language edition. The issue dates on each of these national adoptions will differ as the administrative time to review national standards for possible withdrawal varies. Certification: As we have seen, we have a core ISO document that becomes increasing “wrapped” in layers of administrative adoption 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. Because the EN editions of all standards are called out in the European Union’s regulatory schema (the European Directives harmonization process), many certification professionals will only accept EN standards when reviewing customer facilities and practices.
Additionally, the EN editions have the Z Annexes, 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. 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 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 you’re using.
I hope this is helpful to you. Best regards, Claudia.
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. 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.
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!
And yet, that’s the way the system works Hope this is helpful. Regards, Claudia. 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. 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 it’s one of those three official language editions, it’s always the same (with the exception of the administrative cover sheet material).
I hope this is helpful to you! Regards, Claudia. Great article Claudia!
I posted a comment this morning but I don’t see it in the thread so hopefully this won’t 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 don’t 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.
Thanks so much for asking, Adithyan: These are two separate documents. One is a British Standards series — The BS 7121 series on cranes. You’ll find them as BS-7121-1, BS 7121-2, etc.
Din En Iso 14971 Pdf
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. 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 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. Hi again, Satha: I can easily answer question 1. Any EN is only available in a national adoption.
So all EN’s are not available as the source document given to each of the national bodies. You must purchase them in a national edition only. 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. 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. Best regards, Jonathan. Hi Jonathan: By Jove, you’ve 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 ISO’s 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. I’m glad to be of assistance to you all with this one!
Regards, Claudia. 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, you’ll 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 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.
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. Db2 odbc driver windows 2008. 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 you’re 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 “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.
Hi Claudia, Can the UK, Germany, France issue an “official language” version of an IEC/ISO standard if the EU has not yet recognized it yet? My understanding is that until a standard is recognized as an EN standard in the European Official Journal, it is not recognized as a harmonized standard for use in the EU. However, I’ve started seeing BS/EN/ISO versions of standards before the EN/ISO version is recognized in the OJ. Case in point; EN 60601-2-49:2001 is the latest version in the OJ, but BSI has issued BS EN 60601-2-49:2015. Any insight into this is appreciated. Great question, Bill. We have to think about the EN standardization process as a separate activity from the EU adoption as a harmonized standard.
There’s lots of EN standards. But only a few are part of the harmonized standards set. Because standards development is in the hands of CEN/CENELEC.
Adoption as a harmonized standard is a process for “EU Regulators.” Many are called, but few are chosen, as they say. Take the EN 60601-2-49:2001. This standard is harmonized and found on the list. Why is there a 2015 edition without publication as a harmonized standard? Because an EN standard is written, adopted and published before the administrative review for adoption as a harmonized standard. After the publication of the 2015 Edition, the document was submitted back to the regulators for acceptance.
And for some reason, the administrators rejected it. Somehow it didn’t meet the specifics of the directive anymore. Thus it was not published in the Journal, so it is not harmonized. But it is still an accepted EN standard because publication came before the administrative review.
Just remember: Harmonized EN standards are developed at the request of the regulators. If they are not satisfied with the results, they won’t publish. But the standard has been developed and accepted by either CEN or CENELEC none-the-less. So it’s out there whether they like it or not. But if it isn’t harmonized, it doesn’t meet their criteria as set forth in the directive. It’s just a standard, not a harmonized standard.
I hope this makes sense! Cheers, Claudia.
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