are iso standards the harmonized standards
The new list of harmonised standards on the EU website provides an overview of the most recent changes that have come into effect in January 2013. In those cases, for example, national standards can be used. The harmonised standards are developed by international standards organisations (CEC, ISO), transformed into European standards by the European standards organisations (CEN, CENELEC) and then transposed into national standards. ISO International Standards ensure that products and services are safe, reliable and of good quality. Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Antennas; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive. New standards for medical devices. Compliance with the relevant harmonised standards provides a presumption of conformity, i.e. the device is deemed to satisfy the relevant essential requirements of the directives. However, not all requirements have been specified in harmonised standards. Harmonised Standards take effect when they are cited in the Official Journal of the European Union. This is available from the EUR-Lex website. The most recent Communication (C226/103) listing our Harmonised Standards cited in the Official Journal was 10 July 2015. Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Automatic Vehicle Identification (AVI) for railways operating in the 2,45 GHz frequency range; Part 2: Harmonized standard covering essential requirements under article 3.2 of the R&TTE Directive. Notes to the EU lists of standards: Directive relating to Active Implantable Medical Devices 90/385/EEC (Official Journal notice 2013/C 22/01 of January 24, 2013). 1  This list contains only one new standard: EN ISO 10993-12:2012-07. Staying informed about the latest changes in harmonised standards is important for manufacturers, because these standards specify the basic requirements that Medical Devices must fulfill under the EU directives and the Medical Devices Act. We have produced numerous standards for the Radio & Telecommunications Terminal Equipment (R&TTE) Directive. By adhering to these standards, manufacturers and service providers can demonstrate that they have followed the essential requirements of the directive and are able to claim ‘presumption of conformity’.
Yes