Applying harmonized standards to the product is the safest way
- Each directive sets quality guidelines, thus making it possible to ensure the safe use of the device, protecting the user himself and the environment. All these requirements can be met by complying with applicable standards.
- The best way to demonstrate compliance with the requirements of directives and regulations is the use of harmonized standards (these are technical specifications developed by CEN, CENELEC or ETSI committees and published in the official EU publication and adopted as a national standard by at least one EU member state), thus accepting that the product meets the essential safety requirements .
- The manufacturer is free to choose how to demonstrate conformity to the essential requirements, but must ensure that the minimum requirements of the harmonized standards are met.
- If these standards are not used, according to the directive, the product can be validated by means of an assessment by a notified body.
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