Bs en what does it stand for

But only a few are part of the harmonized standards set. Take the EN This standard is harmonized and found on the list. Why is there a 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 Edition, the document was submitted back to the regulators for acceptance. And for some reason, the administrators rejected it.

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. You bet! Just remember: Harmonized EN standards are developed at the request of the regulators. Thanks, Claudia — It was a very insightful article. I have a follow up question. I work with medical device company and currently am tasked with finding all applicable standards associated with our products.

Compliance with harmonized standards is a requirement of our design controls. When I am referring to standards around sterility, cleaning, packaging. Thanks so much for asking, Yuvaraj: There are a wide variety of EN standards. Certainly, that information is noted in the foreward for sure. The original set of EN standards was created by accepting standards in use by various countries in Europe. Hi Sharm: Thanks so much for asking and sorry to be delayed with my response. When choosing the proper edition of a standard for use within your organization, there are some guidelines that I can offer you.

Since your company has locations and sales within Europe, you probably will be looking for EN versions of the standards you use. This would be to protect you should use of any of your standards be related to meeting the requirements of one or more of the Directives for that region.

Why do I say this? Because the list of Harmonized Standards relating to specific Directives calls out the EN editions of each.

Further, the introductory material states that any standard referenced in a Harmonized standard should be used in the EN edition as well. Nothing is more irritating that finding out you need a different edition of a standard you already own. Good news is that any national edition of an EN standard is acceptable in most cases.

So you can choose from any number of copies, each with a different starting acronym. Sorry to hear you lost your husband. I am working for a global medical device company: Dealings with all regions all over the world. Tasked with global watchlist and process for standards and regulations.

So 1 we have a company who is watching updates for us and notifies us about the new revision etc once we choose the standard to be watched. Should I watch and buy all of them? Date of announcement, publication, withdrawal? Should I monitor the OJ all the time? The company that provides notification is usually few months behind..

For example biocompatibility, sterilisation, packaging. Thanks Aga! So here at Document Center Inc. First, you have to remember that the EN copy is generated first and is given several dates. Important thing is that the first issue date is the core EN standard. Since that core document is not distributed to users but only to national bodies, it will not be your publication date.

To distribute EN Standards, each national body in the EU administratively accepts the document first. Then they republish the core EN standard with their own cover sheet material. This is why your notifications seem to be slightly out-of-date. Having said this, I urge you to use the Harmonized list to determine when new issues of the required documents come into force. Usually you get 3 years to make your transition from one edition to any update.

There are a number of great web-based organizations to help you with all this. I monitor a number of them. Reach out to me offline at claudia. With regards to choosing which national edition you use, I have blogged about this before. There are some industries that do need to keep multiple national editions on hand.

However, for medical devices I have never heard of any auditor requirements more than 1 EN edition for any given standard. I hope my response has been helpful. Your email address will not be published.

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Reply on Twitter Retweet on Twitter Like on Twitter If you work in an industry where chemical splash is a possibility, you must have the the appropriate workwear to reduce the risk of injury. BS EN or subsequent or subsequent replacements for apparatus for connection to any telecommunications network. BS EN or subsequent replacement for laser printers or scanners using lasers. Sample 1. Sample 2. Sample 3.