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The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to so-called technical barriers to trade.
What is a non-harmonized standard. This standard already was replaced by IEC 80601-2-12 not harmonized. Technically the use of a Harmonized Standard is voluntary. In general harmonization is the process of merging two or more different things together.
The European list of harmonized standards was last updated in May 2016. Manufacturers other economic operators or conformity assessment bodies can use harmonised standards. This was the origin of the establishment of ISO.
The EU Declaration of conformity assistant is the most complete web-application for the European Standards This website uses cookies to ensure you get the best experience on our website. Export-minded industries have long sensed the need to agree on world standards to help rationalize the international trading process. Harmonization is the process of minimizing redundant or conflicting standards which may have evolved independently.
European regulators have published updated harmonized standards applicable to the Medical Device Directives in the Official Journal of the European Union. The short answer is that harmonized cables carry the HAR mark a voluntary European mark that has a scope outside the European market. Risk of non-compliance assessment The directives require that the essential requirements are met and the manufacturer is expected to perform a risk of non-compliance assessment demonstrating due diligence.
Non-harmonised sectors are not subject to common EU rules and may come under the national rules. For example you can take advantage of the following standards. And if you read in Beuthde you will also see that the IEC 60601-2-12 is quoted as invalid.
For goods being placed on the Northern Ireland market the CE mark and the harmonised standards can still be used indefinitely. Designated standards give a Presumption of Conformity with the respective UK legislation. A reference to the corresponding requirement in the MDD is helpful here.
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