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Product Compliance - Short Introduction

*Note: The content presented below on the subject of product compliance is only a rough description and does not claim to be complete. The process for ensuring product compliance can vary significantly in detail for each product, directive and standard.*
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The topic of product compliance is an unavoidable topic for every manufacturer of industrial products at the latest when entering the market. Depending on the economic area and the product, the respective specifications for proving the product conformity of the manufactured goods must be observed and verified. The main aim by the legislator here is to enable the safety of the products made availabe for the user and his environment.

Appropriate directives (e.g. low-voltage directive, machine directive) or laws (e.g. product safety law) prompt manufacturers to meet their responsibilities in this regard.

To illustrate this, the CE procedure is to be used as an example, which ends in  the affixing of the well-known CE marking after a successfull application of all neccessary requirements for compliance. It should be emphasized that other economic areas may have other procedures with corresponding special features to prove product compliance.

If the procedure for ensuring CE conformity is almost identical for many products, the individual steps can vary greatly in detail.

The following illustration shows the neccessary steps of the CE procedure:

  1. Determination of the applicable directives

  2. Choosing the appropriate harmonized standards

  3. Implementation of the neccessary protection goals

  4. Creation of a risk assessment

  5. Writing an instruction manual

  6. Cross-checking the results of the conformity assessment for completeness

  7. Preparation of the conformity assessment

  8. Affixing the CE mark

In detail, increased requirements for the product with regard to the respective user (layperson or specially trained taff) and the area of ​​application (special requirements for medical products, explosion-proof devices and systems) are given.

The manufacturer can carry out the verification on his own responsibility if the involvement of a notified body as an independent body is not required in the applicable directive, such e.g. in the case with medical devices.

For the majority of goods from the field of consumer electronics it is possible to carry out product compliance on your own responsibility. After determining the guidelines and standards to be applied, the majority of the effort involved are the technical safety tests, the creation of a well-founded risk assessment and appropriate operating instructions. These results and documents must be kept in the technical documentation.

In order to avoid surprises and complex or cost-intensive subsequent developments, the respective normative requirements on the device should be taken into account as early as the first planning phase of the product.

With so-called type testings, the basic requirements can then be checked on a sample device. For a meaningful conformity check, the production status for this should correspond to that of the final delivery status.

As an example, the scope of testing for a universal transformer power supply unit could include the following:

  • Visual inspection of the external and internal structure

  • assessment of the housing as a protective function for electrical and thermal safety

  • Overcurrent protection

  • Overload and short circuit tests

  • Determination of potential touch voltages and currents, especially leakage currents

  • Determination of potential high surface temperatures

  • Safety in the event of a first failure, e.g. failure of safety-critical components

  • Determination of the cable diameters and their insulation in relation to the current strength

  • Determination of pcbmaterial

  • Structure of the transformer

  • Surge tests to verify protection against overvoltage transients

  • Dielectric strength tests and determination of corresponding air and creepage distances

  • Mechanical tests to determine the strength of the housing

(*Note: the previous list just functions as an general example; a type test can consist of many other crucial points, which are set out in the respective standards; among other things, compliance with the normative limit values ​​is a decision criteria for passing a corresponding test)

Limit values ​​or specifications from the corresponding standards serve as decision criteria for passing the corresponding tests. If limit values ​​are exceeded or if there are deviations, e.g. for the use of the housing as operator protection, this must be improved.

Recognition of components that have already been tested is possible. A current declaration of conformity, ideally a test report or certificate, can be included in the examination and must be included in the technical documentation.

If you need support with product compliance on your products or if you want us to take over the necessary steps, then contact us today and arrange a free initial consultation:

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