Embedded Software Creation II - European Normative & Legislation
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?
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.
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|
|94/9/EC||Equipment and protective systems in potentially explosive atmospheres|
|93/15/EEC||Explosives for civil uses|
|98/79/EC||In vitro diagnostic medical devices|
|2006/95/EC||Low Voltage Equipment|
|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|
|1999/5/EC||Radio and telecommunications terminal equipment|
|87/404/EEC||Simple pressure vessels|
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