Harmonised Standard

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Magnus Dose - One of the best experts on this subject based on the ideXlab platform.

  • development of a european Harmonised Standard to determine the natural radioactivity concentrations in building materials
    Construction and Building Materials, 2018
    Co-Authors: B Michalik, B Hoffmann, Magnus Dose
    Abstract:

    Abstract In 2013 the European Commission has published its latest basic safety Standards for protection against the dangers arising from exposure to ionising radiation (Council Directive 2013/59/Euratom). The council directive regulates radiation exposure from building materials through the presence of radioactivity (226Ra, 232Th and 40K) in these materials. Pivotal to successful regulation is the availability of a Harmonised test method for the determination of the radionuclide concentrations as these nuclides form the basis for dose assessment and compliance. In 2017 a Technical Specification (CEN, 2017) on the determination of the activity concentrations of 226Ra, 232Th and 40K in construction products was published by the European Committee for Standardization (CEN). The purpose of this work is to give an outline of the proposed method, with the protocols for sampling, measurement and data processing as well as a summary of the robustness testing and the expert comments that have been received following the final consultation.

Chris White - One of the best experts on this subject based on the ideXlab platform.

  • Update on the harmonisation of disability data collection in UK surveys (part 2).
    Health statistics quarterly, 2020
    Co-Authors: Chris White
    Abstract:

    This article reports on the field testing work undertaken, leading to the proposals for a primary Harmonised Standard for disability data inputs: designed to derive statistical measures of disability from social surveys using a face-to-face mode of data capture. These proposals were submitted to the National Statistics Harmonisation Group (NSHG) for approval in December 2010. The proposed primary Harmonised Standard data inputs are designed to meet the data needs arising from the equality legislation introduced in 2010 and improve international comparability: by better meeting the definitions for measures of longstanding illness and disability derived from the European Union's Statistics on Income and Living Conditions (EU-SILC). Field testing was conducted during two discrete periods: between October 2009 and February 2010 for stage 1 testing, and between May and July 2010 for stage 2 testing. The Office for National Statistics (ONS) Opinions Survey acted as the data collection vehicle and the design was a split sample in each case. In stage 1, question suite variants were compared, together with the Family Resources Survey (FRS) Disability Discrimination Act module running on the Opinions Survey in equivalent months. The second stage also applied a split sample to compare the revised proposed Harmonised questions with the question on disability planned for the 2011 Census. Derivations of disability to meet measures required under the national Equality Act legislation and the European Union-Statistics on Income and Living Conditions were applied to field-test estimates to assess coherence with contemporaneous external sources. The field test results found good comparability with estimates of disability used in the FRS publications and with the field tested 2011 Census disability question.In stage 1 testing, the measure of disability derived from the version 1 suite was closer to the FRS measure of disability used in FRS publications than that derived from version 2's questions. In stage 2, the proximity of the measure derived from the proposed Harmonised questions to the FRS measure of disability improved, with a 0.5 percentage point difference.The stage 2 measure of disability was found to be consistent with the EU-SILC measure of disability in 2009 for the UK published on the Eurostat website. Furthermore, the Harmonised questions produced a similar estimate of disability to the 2011 Census question, also field tested concurrently with the proposed Harmonised questions. The Harmonised questions tested provide appropriate data inputs to measure persistent illness, impairment and disability, consistent with the components of disability used in the disablement process and the International Classification of Functioning Disability and Health. Their implementation across social survey data sources using a face-to-face mode of data capture will enhance the consistency of statistical measurement and their relevance to the data requirements embodied in national Equality legislation and the EU-SILC European regulation.List of Tables, 33.

  • Update on the harmonisation of disability data collection in UK surveys (Part 2)
    Health Statistics Quarterly, 2011
    Co-Authors: Chris White
    Abstract:

    Background This article reports on the field testing work undertaken, leading to the proposals for a primary Harmonised Standard for disability data inputs: designed to derive statistical measures of disability from social surveys using a face‐to‐face mode of data capture. These proposals were submitted to the National Statistics Harmonisation Group (NSHG) for approval in December 2010. The proposed primary Harmonised Standard data inputs are designed to meet the data needs arising from the equality legislation introduced in 2010 and improve international comparability: by better meeting the definitions for measures of longstanding illness and disability derived from the European Union's Statistics on Income and Living Conditions (EU‐SILC). Methods Field testing was conducted during two discrete periods: between October 2009 and February 2010 for stage 1 testing, and between May and July 2010 for stage 2 testing. The Office for National Statistics (ONS) Opinions Survey acted as the data collection vehicle and the design was a split sample in each case. In stage 1, question suite variants were compared, together with the Family Resources Survey (FRS) Disability Discrimination Act module running on the Opinions Survey in equivalent months. The second stage also applied a split sample to compare the revised proposed Harmonised questions with the question on disability planned for the 2011 Census. Derivations of disability to meet measures required under the national Equality Act legislation and the European Union‐Statistics on Income and Living Conditions were applied to field‐test estimates to assess coherence with contemporaneous external sources. Results The field test results found good comparability with estimates of disability used in the FRS publications and with the field tested 2011 Census disability question. In stage 1 testing, the measure of disability derived from the version 1 suite was closer to the FRS measure of disability used in FRS publications than that derived from version 2's questions. In stage 2, the proximity of the measure derived from the proposed Harmonised questions to the FRS measure of disability improved, with a 0.5 percentage point difference. The stage 2 measure of disability was found to be consistent with the EU‐SILC measure of disability in 2009 for the UK published on the Eurostat website. Furthermore, the Harmonised questions produced a similar estimate of disability to the 2011 Census question, also field tested concurrently with the proposed Harmonised questions. Conclusion The Harmonised questions tested provide appropriate data inputs to measure persistent illness, impairment and disability, consistent with the components of disability used in the disablement process and the International Classification of Functioning Disability and Health. Their implementation across social survey data sources using a face‐to‐face mode of data capture will enhance the consistency of statistical measurement and their relevance to the data requirements embodied in national Equality legislation and the EU‐SILC European regulation. List of Tables, 33

B Michalik - One of the best experts on this subject based on the ideXlab platform.

  • development of a european Harmonised Standard to determine the natural radioactivity concentrations in building materials
    Construction and Building Materials, 2018
    Co-Authors: B Michalik, B Hoffmann, Magnus Dose
    Abstract:

    Abstract In 2013 the European Commission has published its latest basic safety Standards for protection against the dangers arising from exposure to ionising radiation (Council Directive 2013/59/Euratom). The council directive regulates radiation exposure from building materials through the presence of radioactivity (226Ra, 232Th and 40K) in these materials. Pivotal to successful regulation is the availability of a Harmonised test method for the determination of the radionuclide concentrations as these nuclides form the basis for dose assessment and compliance. In 2017 a Technical Specification (CEN, 2017) on the determination of the activity concentrations of 226Ra, 232Th and 40K in construction products was published by the European Committee for Standardization (CEN). The purpose of this work is to give an outline of the proposed method, with the protocols for sampling, measurement and data processing as well as a summary of the robustness testing and the expert comments that have been received following the final consultation.

B Hoffmann - One of the best experts on this subject based on the ideXlab platform.

  • development of a european Harmonised Standard to determine the natural radioactivity concentrations in building materials
    Construction and Building Materials, 2018
    Co-Authors: B Michalik, B Hoffmann, Magnus Dose
    Abstract:

    Abstract In 2013 the European Commission has published its latest basic safety Standards for protection against the dangers arising from exposure to ionising radiation (Council Directive 2013/59/Euratom). The council directive regulates radiation exposure from building materials through the presence of radioactivity (226Ra, 232Th and 40K) in these materials. Pivotal to successful regulation is the availability of a Harmonised test method for the determination of the radionuclide concentrations as these nuclides form the basis for dose assessment and compliance. In 2017 a Technical Specification (CEN, 2017) on the determination of the activity concentrations of 226Ra, 232Th and 40K in construction products was published by the European Committee for Standardization (CEN). The purpose of this work is to give an outline of the proposed method, with the protocols for sampling, measurement and data processing as well as a summary of the robustness testing and the expert comments that have been received following the final consultation.

David H. Adams - One of the best experts on this subject based on the ideXlab platform.

  • CE Marking: stay mobile through the regulation maze
    International Journal of Integrated Care, 2013
    Co-Authors: Sharmila Gardner, Stephen T. Ward, Jane Edwards, David H. Adams
    Abstract:

    Mobile health devices generally use wireless technology to transmit physiological data from sensors and monitoring equipment and patient electronic diaries to another location for review by relevant specialists. Such devices allow for remote management of patients with a range of chronic diseases. This presentation aims to help manufacturers that are new to CE marking navigate through the regulatory maze. There are a number of regulatory issues that a manufacturer of such devices may not have fully considered including: • EU regulations require a clear medical purpose for CE marking as a medical device; the intended use statement can be broader but one or more therapeutic or diagnostic purposes must be identified. The next stage is classification of the medical device – this dictates whether or not notified body involvement is required for CE marking. If the device monitors any vital physiological parameters, the device classification is Class IIa or IIb. If not, the device is Class I can be selfcertified. • Risks associated with design, manufacture and use should be managed as part of a comprehensive quality management system. The Harmonised Standard ISO 14971 can be a useful tool to help satisfy the essential requirements. The risk analysis should also consider foreseeable misuse, sources of electromagnetic disturbances and reciprocal interference in the specific use environment. Data integrity and security are concerns particularly when the data is transmitted wirelessly. • Software development is a special process because the design cannot be verified; only validated. Hence, software lifecycle processes become an important part of the design process. The applicable Harmonised Standard in this area is EN 62304. This Standard also recommends software segregation to control risk and hardware mitigations instead of software mitigation to reduce risk.