What is harmonised legislation?
The scope of product legislation can be general ('any product which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them') and specific ('shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current').
The product legislation thus defines the requirements that a product must meet. In a technical file you collect the documents and certificates that prove that the requirements of the product legislation have been met.
Use of standards
To comply with product legislation (the term used is “to conform with") you can use standards. Standards can be used when all the risks of a product have been identified, so that after a risk assessment you know which essential (or other) requirements apply. Then you evaluate the standard and see if it covers the identified risks.
Application of standards is voluntary. Applying a standard is 'a possible technical way to meet the requirements of product legislation'. The principle is always that an economic operator is responsible for the product. The use of standards remains the responsibility of the economic operator concerned. However, the use of standards is highly recommended, because standards are drawn up by experts in the relevant fields and you therefore do not have to 'reinvent the wheel'. Standards can therefore save you a lot of time, money and effort.For this reason, standards are seen as mandatory. Deviating from available standards can even raise questions: "is there a good reason to ignore the available standards?
Different types of standards?
Presumption of conformity
What does a presumption of conformity mean? A standard is drawn up with a regard to a certain category of products or a certain risk.
When a standard does not cover a product in its entirety, there is no presumption of conformity for the part that the standard does not cover. The economic operator has then to find other standards which cover that other part. If there are no available standards, it is up to the economic operator to cover the risks, so that the product cannot present a hazard.
Furthermore, a (harmonised) standard may not cover all the requirements described in the legislation. There are also standards that only cover part of the risks. It is therefore possible that several (harmonised) standards must be applied for product legislation. In addition, it is common that a product has to comply with different types of product legislation.
- General Product Safety
- Safety of Toys
- RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment)
- EMC (Electro Magnetic Compatibility).
- WEEE (Waste of Electrical and Electronic Equipment
- REACH (Chemical legislation)
Newer standards than harmonised standards
Which standard to apply?
The list of applicable legislation and standards that can be used to demonstrate conformity, that you will see in ProductIP, can (therefore) differ, depending on the date that a product is placed on the market, the 'Market Release Date'. A delay in placing a product on the market may therefore mean that the product no longer complies with the applicable standard(s).
More on this subject can be found here: https://www.productip.com/kb/productipedia/compliance-resources/market-release-date
Are all standards equally important?
- Fundamental standards. These usually contain terminology, instructions and symbols.
- Test and analysis standards. These contain test methods and standards for analysis. They are used to determine certain properties of a product.
- Specification standards. These standards define characteristics of a product (product standards) or a service and the corresponding performance thresholds. These may include fitness for use, interface, interoperability, health and safety
- Organisational standards. These standards describe functions and relationships of business. They are used in quality management, maintenance, production management, system management, etc.