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Perhaps it would help with general understanding if, instead of using "European version" as the practical meaning of EN (as opposed to (en), the language indication), we consistently said "EC Harmonized version".
Lots of standards are in use in Europe, and available in an English language version, but are not EC Harmonized. It's very important to distinguish between EN standards and (en) standards.
The rule as I understand it for demonstration of conformance to the Essential Requirements is:
1. Declare conformance to an EN standard, with appropriate documentation. The reviewing body must presume validity of the declaration, assuming proper documentation.
2. Or, as a second option, declare conformance to a non-EN standard. This might be an international standard that for some reason has not been formally adopted by the EC central authority and the member nations, or a standard that is recognized nationally but not internationally. In this case, there is a limited presumption of conformance, but the reviewing body may conduct a more thorough review of the conformance evidence.
3. Or, as a third option, demonstrate conformance to the Essential Requirements via other evidence. In this case, the reviewing body may require a comprehensive explanation of the adequacy of the conformance, and the burden of proof is on the claimant.
Lots of standards are in use in Europe, and available in an English language version, but are not EC Harmonized. It's very important to distinguish between EN standards and (en) standards.
The rule as I understand it for demonstration of conformance to the Essential Requirements is:
1. Declare conformance to an EN standard, with appropriate documentation. The reviewing body must presume validity of the declaration, assuming proper documentation.
2. Or, as a second option, declare conformance to a non-EN standard. This might be an international standard that for some reason has not been formally adopted by the EC central authority and the member nations, or a standard that is recognized nationally but not internationally. In this case, there is a limited presumption of conformance, but the reviewing body may conduct a more thorough review of the conformance evidence.
3. Or, as a third option, demonstrate conformance to the Essential Requirements via other evidence. In this case, the reviewing body may require a comprehensive explanation of the adequacy of the conformance, and the burden of proof is on the claimant.
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