Types of Standards and Harmonized Standards

[Ethan Loh]

Hi everybody,

Can anyone tell me what is the differences between the following standards?

1. Harmonized standard such as EN 980:2008
2. BS EN, DIN EN, etc....
3. ISO standards


My company had a few Technical Files for CE mark and it is a must to comply to the harmonized standards?

What happened if we do not comply to the harmonized standard but only to the ISO standards?

Please advise

[Marcelo Antunes]

Hello Ethan

Can anyone tell me what is the differences between the following standards?

1. Harmonized standard such as EN 980:2008
2. BS EN, DIN EN, etc....
3. ISO standards

An ISO or IEC standard is a INTERNATIONAL standard, published by an international SDO - standard development organization, meaning it´s generally recognized by the members bodies of ISO and IEC as the standard on the subject.

Standards are by default voluntary. Countries or regions (case of the EU), when they want to use standards in their regulations, have to call them in the regulation to make it an option or mandatory or whatever.

Due to a lot of reasons, countries or regions usually cannot directly use an international standard...they have to use a country or region specific version of the standard. These are developed by SDOs from countries or regions.

In the case of the EU, the SDOs are CEN or CENELEC (the EU ISO and IEC) which publishes EN standards (European Norms).

Harmonized standards are related to the directives in place on the EU. Basically, directives gives essential, general requirements, and harmonized standards provide more detailed requirements. Please note that, although harmonized standards are considered the "gold standard" on the subject (state of the art) they are are still voluntary - the manufacturer of the device can use any technical solution thet they see fit. The problem here is that compliance with harmonized standards gives what the directives call "presumption of conformity" with the related essential requirements. Oher standards or other solutions do not give this. So if not using an harmonized standard, you will need to justiry (in your risk management file) that the level of safety your product has is the nsame as if using a harmonized standard.

Finally, due to a lot of other reasons (mainly new approach directives and the global approach framework), countries in the EU have to have their own version of harmonized standards, or have to accept the general EU standard as a national standard. That´s why we have BS EN (british implementation of the EU standard), DIN EN (german implementation of the EU standard) and etc.

[zolakeene]

Hi

Happy Nerw Year

Can anyone help me?

I am trying to find a standard that relates to corrugated tubing for the medical industry?

many thanksa
Zola

[SteveK]

Hi Zola,

The only standard I am aware of is BS EN 13544-2:2002 "Respiratory therapy equipment - Part 2: Tubing and connectors".

It is not specific to corrugated tubing, but it indicates a test for resistance to kinking, security of connectors, the fact that it is oxygen compatible etc. Not very detailed, but often some of the medical device standards are basic.

It is possible there are some references in other (harmonised) standards e.g. Lung Ventilator series - EN ISO 10651 - but I do not have copies of these so cannot comment.

I hope this is of some help.

Steve

[zolakeene]

Hi Guys

Can any give me a shove in the right direction need to prepare a presentation "Implementation of production operator led inspection, requirements and strategy£

[DynaPur]

Marcelo, I just registered with ELSMAR yesterday and was searching for answers on this same topic for a non-medical field but I'm sure your info still applies.

Just to clarify, an IEC standard would NOT be a Harmonised Standard on an EU DoC, correct? We have a DoC from very large global manufacturer that is listing just IEC standards. Our client (who requested the DoC) said this is not acceptable. The supplier sent back the CENELEC listing of the 61326-2-1:2006 standard. The EN version is listed at the top of the listing paragraph and the paragraph concludes with the IEC version of the same. As a newcomer to the whole CE marking process, basic logic would dictate that the EN standard is what one would list so the manufacturer's "justification" for using IEC vs. EN coupled with your info means to me that the supplier's justification doesn't really hold water.

Do you have any suggestions (the Europa website aside) where I could find concise information as to what is required on EU DoC's?

[renenatasha]

In Reply to Parent Post by Marcelo Antunes

Hello Ethan



An ISO or IEC standard is a INTERNATIONAL standard, published by an international SDO - standard development organization, meaning it´s generally recognized by the members bodies of ISO and IEC as the standard on the subject.

Standards are by default voluntary. Countries or regions (case of the EU), when they want to use standards in their regulations, have to call them in the regulation to make it an option or mandatory or whatever.

Due to a lot of reasons, countries or regions usually cannot directly use an international standard...they have to use a country or region specific version of the standard. These are developed by SDOs from countries or regions.

In the case of the EU, the SDOs are CEN or CENELEC (the EU ISO and IEC) which publishes EN standards (European Norms).

Harmonized standards are related to the directives in place on the EU. Basically, directives gives essential, general requirements, and harmonized standards provide more detailed requirements. Please note that, although harmonized standards are considered the "gold standard" on the subject (state of the art) they are are still voluntary - the manufacturer of the device can use any technical solution thet they see fit. The problem here is that compliance with harmonized standards gives what the directives call "presumption of conformity" with the related essential requirements. Oher standards or other solutions do not give this. So if not using an harmonized standard, you will need to justiry (in your risk management file) that the level of safety your product has is the nsame as if using a harmonized standard.

Finally, due to a lot of other reasons (mainly new approach directives and the global approach framework), countries in the EU have to have their own version of harmonized standards, or have to accept the general EU standard as a national standard. That´s why we have BS EN (british implementation of the EU standard), DIN EN (german implementation of the EU standard) and etc.

Hi Marcelo,

I'm quite new to this so-called "Harmonized Standard" too. As far as I can recall, I thought we only have to note down those we use (or comply)? Hmm... is my understanding correct? Or we have to note whatever that relates? Oh BTW, the harmonized standards are only mentioned in the Essential Requirement and not in the Risk Management. Is this alright?

Sorry for the endless questions
Anyway, thanks for your advice. It's been of great help. - Rene