Embedded Software Creation II - European Normative & Legislation

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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 about directive	Standards activities	References harmonised standards
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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