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Embedded Software Creation II - European Normative & Legislation

Dr. Maykel AlonsoDecember 20, 20116 comments

In this post I will explain the European Normative. I will answer the main questions and I will be open to answer all the doubts any of you could have. Please leave a comment and I will answer if i could.

Why I need to look and accomplish some standards? 

The main reason is if you want to comercialize the product in the European Union, if exists any European Directive that cover the product, the product must be marked with the CE mark. For USA it work in the same way by the FCC.

How does it work the European Normative and Legislation?

The European Union sets out the guidelines and standards by the European Directives, as it is said in the previus sentence, they are only guides or standards and they are not exactly laws. Each country has the final decision to adopt them as laws. It usually takes several years for the countries to adopt the guides or standards into legislation. So in design stages It is better to look in the Official Journal of the European Union OJEU (link), besides all the countries have pacted adopt all the guides or standards to its own legislation.

What are the diferent types of European Directives?


Global Approach

This directives are evaluated by the System of Quality that the manufacturer or the designer has in the cycle life of the product. That means when the products is ready to comercialize, the market or the end customer will be the one who evaluates the products.

New Approach

This directives are different, to accomplish this directives you need to satisfy fabrication methods, cylce life of the product and some rules or standards for the  interoperability and the coexistance of the diferent products, for example: Electomagnetic Rules (EMC); Medium Access Rules, etc...

All these Standards or Rules can be found in the OJEU (link). In the next question  will found the links for the communications in the colum called "References Harmonised Standards".


What are the European Directives?

 In the next table you will find a resume of the European Directives and the products are covered:

Directives & Standards
Directive reference Subject of directive Info
90/385/EEC Active implantable medical devices
90/396/EEC Appliances burning gaseous fuels
2000/9/EC Cableway installations designed to carry persons
89/106/EEC Construction products
2004/108/EC Electromagnetic compatability
2004/108/EC Electromagnetic compatibility
94/9/EC Equipment and protective systems in potentially explosive atmospheres
93/15/EEC Explosives for civil uses
90/396/EEC Gas appliances
98/79/EC In vitro diagnostic medical devices
95/16/EC Lifts
2006/95/EC Low Voltage Equipment
2006/42/EC Machinery safety
2004/22/EC Measuring instruments
93/42/EEC Medical devices
90/385/EEC Medical devices: Active implantable
93/42/EEC Medical devices: General
98/79/EC Medical devices: In vitro diagnostic
92/42/EEC New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements)  
90/384/EEC Non-automatic weighing instruments
94/62/EC Packaging and packaging waste  
89/686/EEC Personal protective equipment
97/23/EC Pressure equipment
1999/5/EC Radio and telecommunications terminal equipment
94/25/EC Recreational craft
87/404/EEC Simple pressure vessels
88/378/EEC Toys safety

Source: http://www.newapproach.org/


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Comment by jms_nhDecember 14, 2011
What exactly do you mean by "normative" as a noun? I'm familiar with its use in standards (e.g. normative definitions as in http://www.w3.org/TR/xhtml1/normative.html or non-normative information) but I don't understand what you mean here.
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Comment by MaykelDecember 15, 2011
Maybe It is betterto sayhere legislation. But when I'm looking for requeriemnts, I'm used to call all this types of requirements as normative, so you are rigth and I add to the title "&legislation"
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Comment by MaykelDecember 19, 2011
I have edited the post and I've corrected all the language errors, besides I've put the info in a diferent way. I think now It is easier to understand.
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Comment by JoanCarlesMarch 28, 2012
I thing the title is misleading because these directives do not address to software but hardware.
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Comment by MaykelMarch 28, 2012
Hi JoanCarles, First thanks for the comment. These directives address from design to fabrication. In many of them it is required developing the Software with a certain cycle life. For example for the directive 90/385/EEC the software must satisfy the EN 62304-2007 relativeto the "Software life-cycle processes". So definetly it's necesary to check them. I hope this could clarify you about it. Regards, Maykel
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Comment by tasbihmrSeptember 22, 2012
Very interesting and informative post. I am actually myself looking for some post on the internet about ths. It is nice to have it right here.

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