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    <title language="eng">Counting Small Particles in Electron Microscopy Images — Proposal for Rules and Their Application in Practice</title>
    <abstract language="eng">Electron microscopy (EM) is the gold standard for the characterisation of the morphology (size and shape) of nanoparticles. Visual observation of objects under examination is always a necessary first step in the characterisation process. Several questions arise when undertaking to identify and count particles to measure their size and shape distribution. In addition to challenges with the dispersion and identification of the particles, more than one protocol for counting particles is in use. This paper focuses on precise rules for the counting of particles in EM micrographs, as this influences the measurement accuracy of the number of particles, thus implicitly affecting the size values of the counted particles. We review and compare four different, commonly used methods for counting, which we then apply in case studies. The impact of the selected counting rule on the obtained final particle size distribution is highlighted. One main aim of this analysis is to support the application of a specific, well-defined counting approach in accordance with regulatory&#13;
requirements to contribute to achieving more reliable and reproducible results. It is also useful for the new harmonised measurement procedures for determining the particle size and particle size distribution of nanomaterials.</abstract>
    <parentTitle language="eng">Nanomaterials</parentTitle>
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    <author>Harald Bresch</author>
    <author>Vasile-Dan Hodoroaba</author>
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    <title language="deu">Tour de table - BAM</title>
    <abstract language="deu">Kurzübersicht über die neuen Aktivitäten zu Nanomaterialien in 2021.</abstract>
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    <author>Harald Bresch</author>
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      <value>Bundesoberbehörden</value>
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    <publishedYear>2021</publishedYear>
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    <title language="eng">Nanocarriers – Challenges Imposed by Material Characterization</title>
    <abstract language="eng">A brief perspective of BAM on nanocarriers is presented including examples with special emphasis on the characterization of such materials and underlying challenges. In this respect, also ongoing activities at BAM on different types of core/shell nanomaterials and related systems are briefly summarized.</abstract>
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    <author>Ute Resch-Genger</author>
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      <value>Nanocarrier</value>
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      <value>Release kinetics</value>
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      <value>Chemical composition</value>
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      <type>uncontrolled</type>
      <value>Core/shell nanoparticle</value>
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    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Quantum dot</value>
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    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Spectroscopy</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Fluorescence</value>
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    <collection role="ddc" number="543">Analytische Chemie</collection>
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    <volume>JRC117501</volume>
    <type>handbook</type>
    <publisherName>Publications Office of the European Union</publisherName>
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    <title language="eng">The NanoDefine Methods Manual</title>
    <abstract language="eng">This document is a collection of three JRC Technical Reports that together form the “NanoDefine Methods Manual”, which has been developed within the NanoDefine project ‘Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial’, funded by the European Union’s 7th Framework Programme, under grant agreement 604347. The overall goal of the NanoDefine project was to support the implementation of the European Commission Recommendation on the definition of nanomaterial (2011/696/EU). The project has developed an integrated empirical approach, which allows identifying a material as a nano- or not a nanomaterial according to the EC Recommendation. The NanoDefine Methods Manual consists of three parts: Part 1: The NanoDefiner Framework and Tools, which covers the NanoDefiner framework, general information on measurement methods and performance criteria, and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool. Part 2: Evaluation of Methods, which discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size. Part 3: Standard Operating Procedures (SOPs), which presents the 23 Standard Operating Procedures developed within the NanoDefine project. In this combined document, these three parts are included as stand-alone reports, each having its own abstract, table of contents, page, table and figure numbering, and references.</abstract>
    <identifier type="isbn">978-92-76-12335-4</identifier>
    <identifier type="doi">10.2760/79490</identifier>
    <identifier type="urn">urn:nbn:de:kobv:b43-504250</identifier>
    <licence>Creative Commons - CC BY - Namensnennung 4.0 International</licence>
    <author>C. M. Friedrich</author>
    <author>S. Weigel</author>
    <author>H. Marvin</author>
    <author>H. Rauscher</author>
    <author>W. Wohlleben</author>
    <author>F. Babick</author>
    <author>K. Löschner</author>
    <author>A. Mech</author>
    <author>R. Brüngel</author>
    <author>Vasile-Dan Hodoroaba</author>
    <author>D. Gilliland</author>
    <author>K. Rasmussen</author>
    <author>A. Ghanem</author>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Particle size distribution</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanoparticles</value>
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    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>NanoDefine</value>
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    <subject>
      <language>eng</language>
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      <value>Nanomaterial classification</value>
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    <collection role="ddc" number="543">Analytische Chemie</collection>
    <collection role="ddc" number="620">Ingenieurwissenschaften und zugeordnete Tätigkeiten</collection>
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    <title language="eng">The NanoDefine Methods Manual - Part 3: Standard Operating Procedures (SOPs)</title>
    <abstract language="eng">The present series of reports, the NanoDefine Methods Manual, has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial'1 funded by the European Union's 7th Framework Programme, under grant agreement 604347.&#13;
In 2011 the European Commission (EC) published the recommendation (2011/696/EU) for a definition of the term 'nanomaterial'1, the EC NM Definition, as a reference to determine whether an unknown material can be considered as a 'nanomaterial' for regulatory purposes. One challenge is the development of methods that reliably identify, characterize and quantify nanomaterials (NM) both as substances and in various products and matrices.&#13;
The overall goal of NanoDefine was to support the implementation of the EC NM Definition. It can also support the implementation of any NM definition based on particle size. The project has developed an integrated approach, which allows identifying any material as a nano or non-nano material according to the EC NM Definition. NanoDefine explicitly supported the governance challenges associated with the implementation of legislation concerning nanomaterials by:&#13;
- addressing the issues on availability of suitable measuring techniques, reference materials, validated methods, acceptable to all - developing an integrated and interdisciplinary approach and a close international co-operation and networking with academia, commercial firms and standardization bodies.&#13;
Thus, the NanoDefine Methods Manual provides guidance on practical implementation of the EC NM Definition throughout the nanomaterial characterization process, and on the characterization techniques employed as well as their application range and limits. It assists the user in choosing the most appropriate measurement method(s) to identify any substance or mixture for a specific purpose, according to the EC NM Definition of a nanomaterial. The NanoDefine project also explored how to assess a material against the criteria of the definition through proxy solutions, i.e. by applying measurement techniques that indirectly determine the D50. Those findings were developed through empirically based scientific work and are included in Part 1 of this Manual. As they go beyond the text of the EC NM Definition, they may be used as practical approach to indicate whether a material is a nanomaterial or not, but keeping in mind that they should not be taken as recommendation for the implementation of the EC NM Definition in a regulatory context.&#13;
The NanoDefine Methods Manual consists of the following three parts:&#13;
 Part 1: The NanoDefiner Framework and Tools&#13;
 Part 2: Evaluation of Methods&#13;
 Part 3: Standard Operating Procedures (SOPs)&#13;
Part 1 covers the NanoDefiner framework, general information on measurement methods and performance criteria and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool.&#13;
Part 2 discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size.&#13;
Part 3 presents the 23 Standard Operating Procedures developed within the NanoDefine project. The current document is part 3.</abstract>
    <parentTitle language="eng">NanoDefine Methods Manual</parentTitle>
    <identifier type="isbn">978-92-76-11955-5</identifier>
    <identifier type="doi">10.2760/02910</identifier>
    <identifier type="issn">1831-9424</identifier>
    <identifier type="urn">urn:nbn:de:kobv:b43-503710</identifier>
    <licence>Creative Commons - CC BY - Namensnennung 4.0 International</licence>
    <author>A. Mech</author>
    <author>H. Rauscher</author>
    <author>K. Rasmussen</author>
    <author>F. Babick</author>
    <author>Vasile-Dan Hodoroaba</author>
    <author>A. Ghanem</author>
    <author>W. Wohlleben</author>
    <author>H. Marvin</author>
    <author>R. Brüngel</author>
    <author>C. M. Friedrich</author>
    <author>K. Löschner</author>
    <author>D. Gilliland</author>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanoparticles</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Particle size distribution</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>NanoDefine</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Standard Operation Procedures</value>
    </subject>
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      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial classification</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>SOP</value>
    </subject>
    <collection role="ddc" number="543">Analytische Chemie</collection>
    <collection role="ddc" number="620">Ingenieurwissenschaften und zugeordnete Tätigkeiten</collection>
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    <file>https://opus4.kobv.de/opus4-bam/files/50371/KJNC29876ENN.en.pdf</file>
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    <title language="eng">The NanoDefine Methods Manual - Part 2: Evaluation of methods</title>
    <abstract language="eng">The present series of reports, the NanoDefine Methods Manual, has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial', funded by the European Union's 7th Framework Programme, under grant agreement 604347.&#13;
In 2011 the European Commission (EC) published a recommendation for a definition of the term 'nanomaterial', the EC NM Definition, as a reference to determine whether an unknown material can be considered as a 'nanomaterial' for regulatory purposes1. One challenge is the development of methods that reliably identify, characterize and quantify nanomaterials (NM) both as substances and in various products and matrices.&#13;
The overall goal of NanoDefine was to support the implementation of the EC NM Definition. It can also support the implementation of any NM definition based on particle size. The project has developed an integrated approach, which allows identifying any material as a nano- or not a nanomaterial according to the EC NM Definition. NanoDefine explicitly supported the governance challenges associated with the implementation of legislation concerning nanomaterials by:&#13;
- addressing the issues on availability of suitable measuring techniques, reference materials, validated methods, acceptable to all stakeholders (authorities, policy makers, commercial firms),&#13;
- developing an integrated and interdisciplinary approach and a close international co-operation and networking with academia, commercial firms and standardization bodies.&#13;
Thus, the NanoDefine Methods Manual provides guidance on practical implementation of the EC NM Definition throughout the nanomaterial characterization process, and on the characterization techniques employed as well as their application range and limits. It assists the user in choosing the most appropriate measurement method(s) to identify any substance or mixture for a specific purpose, according to the EC NM Definition of a nanomaterial. The NanoDefine project also explored how to assess a material against the criteria of the definition through proxy solutions, i.e. by applying measurement techniques that indirectly determine the x50. Those findings were developed through empirically based scientific work and are included in Part 1 of this Manual. As they go beyond the text of the EC NM Definition, they may be used as practical approach to indicate whether a material is a nanomaterial or not, but keeping in mind that they should not be taken as recommendation for the implementation of the EC NM Definition in a regulatory context.&#13;
The NanoDefine Methods Manual consists of the following three parts:&#13;
 Part 1: The NanoDefiner Framework and Tools&#13;
 Part 2: Evaluation of Methods&#13;
 Part 3: Standard Operating Procedures (SOPs)&#13;
Part 1 covers the NanoDefiner framework, general information on measurement methods and performance criteria and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool.&#13;
Part 2 discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size.&#13;
Part 3 presents the 23 Standard Operating Procedures developed within the NanoDefine project.&#13;
The current document is part 2.</abstract>
    <parentTitle language="eng">The NanoDefine Methods Manual</parentTitle>
    <identifier type="isbn">978-92-76-11953-1</identifier>
    <identifier type="doi">10.2760/071877</identifier>
    <identifier type="issn">1831-9424</identifier>
    <identifier type="urn">urn:nbn:de:kobv:b43-503708</identifier>
    <licence>Creative Commons - CC BY - Namensnennung 4.0 International</licence>
    <author>A. Mech</author>
    <author>H. Rauscher</author>
    <author>K. Rasmussen</author>
    <author>F. Babick</author>
    <author>Vasile-Dan Hodoroaba</author>
    <author>A. Ghanem</author>
    <author>W. Wohlleben</author>
    <author>H. Marvin</author>
    <author>R. Brüngel</author>
    <author>C. M. Friedrich</author>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanoparticles</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>NanoDefine</value>
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    <title language="eng">The NanoDefine Methods Manual - Part 1: The NanoDefiner Framework and Tools</title>
    <abstract language="eng">The present series of reports, the NanoDefine Methods Manual, has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial', funded by the European Union's 7th Framework Programme, under grant agreement 604347.&#13;
In 2011 the European Commission (EC) published a recommendation for a definition of the term 'nanomaterial', the EC NM Definition, as a reference to determine whether an unknown material can be considered as a 'nanomaterial' for regulatory purposes1. One challenge is the development of methods that reliably identify, characterize and quantify nanomaterials (NM) both as substances and in various products and matrices.&#13;
The overall goal of NanoDefine was to support the implementation of the EC NM Definition. It can also support the implementation of any NM definition based on particle size. The project has developed an integrated approach, which allows identifying any material as a nano- or not a nanomaterial according to the EC NM Definition. NanoDefine explicitly supported the governance challenges associated with the implementation of legislation concerning nanomaterials by:&#13;
- addressing the issues on availability of suitable measuring techniques, reference materials, validated methods, acceptable to all stakeholders (authorities, policy makers, commercial firms),&#13;
- developing an integrated and interdisciplinary approach and a close international co-operation and networking with academia, commercial firms and standardization bodies.&#13;
Thus, the NanoDefine Methods Manual provides guidance on practical implementation of the EC NM Definition throughout the nanomaterial characterization process, and on the characterization techniques employed as well as their application range and limits. It assists the user in choosing the most appropriate measurement method(s) to identify any substance or mixture for a specific purpose, according to the EC NM Definition of a nanomaterial. The NanoDefine project also explored how to assess a material against the criteria of the definition through proxy solutions, i.e. by applying measurement techniques that indirectly determine the x50. Those findings were developed through empirically based scientific work and are included in Part 1 of this Manual. As they go beyond the text of the EC NM Definition, they may be used as practical approach to indicate whether a material is a nanomaterial or not, but keeping in mind that they should not be taken as recommendation for the implementation of the EC NM Definition in a regulatory context.&#13;
The NanoDefine Methods Manual consists of the following three parts:&#13;
 Part 1: The NanoDefiner Framework and Tools&#13;
 Part 2: Evaluation of Methods&#13;
 Part 3: Standard Operating Procedures (SOPs)&#13;
Part 1 covers the NanoDefiner framework, general information on measurement methods and performance criteria and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool.&#13;
Part 2 discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size.&#13;
Part 3 presents the 23 Standard Operating Procedures developed within the NanoDefine project.&#13;
The current document is part 1.</abstract>
    <identifier type="isbn">978-92-76-11950-0</identifier>
    <identifier type="doi">10.2760/55181</identifier>
    <identifier type="issn">1831-9424</identifier>
    <identifier type="urn">urn:nbn:de:kobv:b43-503699</identifier>
    <licence>Creative Commons - CC BY - Namensnennung 4.0 International</licence>
    <author>A. Mech</author>
    <author>H. Rauscher</author>
    <author>F. Babick</author>
    <author>Vasile-Dan Hodoroaba</author>
    <author>W. Wohlleben</author>
    <author>H. Marvin</author>
    <author>S. Weigel</author>
    <author>R. Brüngel</author>
    <author>C. M. Friedrich</author>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanoparticles</value>
    </subject>
    <subject>
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      <type>uncontrolled</type>
      <value>NanoDefine</value>
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    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanoparticle size distribution</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Nanomaterial classification</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Framework</value>
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    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>Tools</value>
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    <collection role="themenfelder" number="">Advanced Materials</collection>
    <thesisPublisher>Bundesanstalt für Materialforschung und -prüfung (BAM)</thesisPublisher>
    <file>https://opus4.kobv.de/opus4-bam/files/50369/KJNA29876ENN.en.pdf</file>
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