1、PAS 131:2007Terminology for medical, health and personal care applications of nanotechnologyICS 01.040.11; 11.040.99NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWPUBLICLY AVAILABLE SPECIFICATIONPublishing and copyright informationThe BSI copyright notice displayed in this doc
2、ument indicates when the document was last issued. BSI 2007ISBN 978 0 580 61316 6Publication historyFirst published December 2007Amendments issued since publicationAmd. no. Date Text affectedPAS 131:2007 BSI 2007 iPAS 131:2007ContentsForeword iiiIntroduction 11 Scope 12 General 13 Molecular entities
3、 34 Structural entities 45 Nanosystems 7Bibliography 8Summary of pagesThis document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 8, an inside back cover and a back cover.PAS 131:2007ii BSI 2007 This page deliberately left blank BSI 2007 iiiPAS 131:2007ForewordPublishing
4、informationThis Publicly Available Specification (PAS) has been commissioned by the UK Department for Innovation, Universities and Skills (DIUS) and developed through the British Standards Institution (BSI). It came into effect on 31 December 2007. Acknowledgement is given to the following organizat
5、ions that were involved in the development of this terminology: Institute of Nanotechnology; Medwise International Consultancy; Queen Mary, University of London; The British Healthcare Trades Association;Smith and Nephew.In addition, acknowledgement is given to the contributions of those that commen
6、ted, including BSI Technical Committee NTI/1, Nanotechnologies, the working groups of ISO Technical Committee ISO/TC 229, Nanotechnologies, and other organizations and experts.BSI retains ownership and copyright of this PAS. BSI reserves the right to withdraw or amend this PAS on receipt of authorit
7、ative advice that it is appropriate to do so. This PAS will be reviewed at intervals not exceeding two years, and any amendments arising from the review will be published as an amended PAS and publicized in Update Standards.This PAS is not to be regarded as a British Standard. It will be withdrawn u
8、pon publication of its content in, or as, a British Standard.The PAS process enables a specification to be rapidly developed in order to fulfil an immediate need in industry. A PAS may be considered for further development as a British Standard, or constitute part of the UK input into the developmen
9、t of a European or International Standard.Relationship with other publicationsThis PAS is issued as part of a suite of nanotechnology terminology PASs: PAS 71, Vocabulary Nanoparticles; PAS 131, Terminology for medical, health and personal care applications of nanotechnologies; PAS 132, Terminology
10、for the bio-nano interface; PAS 133, Terminology for nanoscale measurement and instrumentation; PAS 134, Terminology for carbon nanostructures; PAS 135, Terminology for nanofabrication; PAS 136, Terminology for nanomaterials.PAS 131:2007iv BSI 2007PAS 131 to PAS 136 include terms the definitions for
11、 which differ to those given in PAS 71:2005, which was published a few years earlier. These differences are the result of further reflection and debate and reflect consensus within the PAS steering groups. Until PAS 71:2005 can be revised to incorporate these changes, it is intended that the terms i
12、n PAS 131 to PAS 136 take precedence over PAS 71:2005.This suite of PASs acknowledges the standards development work being conducted by BSI Technical Committee NTI/1, Nanotechnologies, ISO TC/229, Nanotechnologies, IEC/TC 113, Nanotechnology standardization for electrical and electronic products and
13、 systems, and CEN/TC 352, Nanotechnologies. Attempts have been made to align the definitions in these PASs with the definitions being developed by these committees, particularly the draft ISO/TS 27687, Terminology and definitions for nanoparticles. However, as the work of these committees is at a de
14、velopment stage, complete alignment has not been possible in every instance.Contractual and legal considerationsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a Publicly Available Specificatio
15、n cannot confer immunity from legal obligations. BSI 2007 1PAS 131:2007IntroductionMany authorities predict that applications of nanotechnologies will ultimately pervade virtually every aspect of life and will enable dramatic advances to be realized in most areas of communication, health, manufactur
16、ing, materials and knowledge-based technologies. Even if this is only partially true, there is an obvious need to provide industry and research with suitable tools to assist the development, application and communication of the technologies. One essential tool in this armoury will be the harmonizati
17、on of the terminology and definitions used in order to promote their common understanding and consistent usage.This terminology includes terms that are either specific to the sector covered by the title or are used with a specific meaning in the field of nanotechnology. It is one of a series of term
18、inology PASs covering many different aspects of nanotechnologies.This terminology attempts not to include terms that are used in a manner consistent with a definition given in the Oxford English Dictionary 1, and terms that already have well established meanings and to which the addition of the pref
19、ix “nano” changes only the scale to which they apply but does not otherwise change their meaning.The multidisciplinary nature of nanotechnologies can lead to confusion as to the precise meaning of some terms because of differences in usage between disciplines. Users are advised that, in order to sup
20、port the standardization of terminology, this PAS provides single definitions wherever possible.1 ScopeThis Publicly Available Specification (PAS) lists terms and definitions used in or associated with naming or describing applications of nanotechnologies and nanomaterials for medicinal products, me
21、dical devices, cosmetics, sunscreens and other personal care products.This PAS is intended for use by technologists, regulators, non-governmental organizations (NGOs), consumer organizations, members of the public and others with an interest in the medical, health and personal care applications of n
22、anotechnology.2 General2.1 active nanostructurenanostructure that achieves its intended function by virtue of a change of state during application and/or in response to an external or endogenous influence, or which has a direct influence on the system to which it is applied2.2 nanobiotechnologyuse o
23、f biological components and/or construction principles for the design, characterization, production and application of structures, devices and systems in the nanoscalePAS 131:20072 BSI 20072.3 nanocosmeticcosmetic produced incorporating or utilizing nanomaterials and/or nanotechnology2.4 nanofluidic
24、sstudy and development of fluid flow in and through engineered nanostructures2.5 nanointerventionmanipulation at the cellular and subcellular level using nanoscale properties of materials or systems2.6 nanomaterialmaterial with one or more external dimensions in the nanoscale or which is nanostructu
25、redNOTE Nanomaterials can exhibit properties that differ from those of the same material without nanoscale features.2.7 nanomedicineapplication of nanotechnology to achieve advances in healthcare by exploiting the physical, chemical and biological properties of materials operating in the nanoscaleNO
26、TE Nanomedicine has the potential to enable early detection and prevention, and to essentially improve diagnosis, treatment and follow-up of diseases.derived from the European Technology Platform for Nanotechnology 22.8 nano-objectdiscrete piece of material with one or more external dimensions in th
27、e nanoscaleNOTE This is a generic term for all nanoscale objects.ISO/TS 276871)2.9 nanoparticlenano-object with all three external dimensions in the nanoscaleNOTE If the lengths of the longest and the shortest axes of the nano-object differ significantly (typically by more than three times) the term
28、s nanorod or nanoplate are intended to be used instead of the term nanoparticle.ISO/TS 276871)2.10 nanopharmaceuticalmedicinal preparation making use of material properties in the nanoscaleNOTE 1 This is sometimes colloquially known as a nanoceutical.NOTE 2 An example includes nanoparticles for drug
29、 delivery applications.derived from the Nanodictionary 31)In preparation. BSI 2007 3PAS 131:20072.11 nanoscalesize range from approximately 1 nm to 100 nmNOTE 1 Properties that are not extrapolations from larger size will typically, but not exclusively, be exhibited in this size range.NOTE 2 The low
30、er limit in this definition (approximately 1 nm) has no physical significance but is introduced to avoid single and small groups of atoms from being designated as nano-objects or elements of nanostructures, which might be implied by the absence of a lower limit. ISO/TS 276872)2.12 nanosciencestudy o
31、f phenomena, novel characteristics and manipulation of materials in the nanoscale2.13 nanostructurenanoscale structureNOTE Also see definitions of active nanostructure and passive nanostructure.2.14 nanostructuredpossessing a structure comprising contiguous elements with one or more dimension in the
32、 nanoscale but excluding any primary atomic or molecular structureNOTE 1 An example of a primary atomic or molecular structure is the arrangement of atoms in a crystalline solid.NOTE 2 The use of the term contiguous implies that a sphere of approximately 100 nm diameter, inscribed in a nanostructure
33、d material, will intersect more than one element of the structure.2.15 nanotechnologydesign, characterization, production and application of structures, devices and systems by controlling shape and size in the nanoscalederived from Nanoscience and nanotechnologies 42.16 passive nanostructurenanostru
34、cture that achieves its intended function through stable behaviour or propertiesNOTE 1 Passive nanostructures show morphological stability and stability of their chemical, physical or biological properties.NOTE 2 Changes in state can be morphological, chemical, physical or biological.3 Molecular ent
35、ities3.1 fullereneclosed-cage structure having more than 20 carbon atoms consisting entirely of three-coordinate carbon atomsNOTE A fullerene with 60 carbon atoms (C60) is sometimes called buckminsterfullerene.J. Chem. Inf. Comp. Sci., 35, 969-978 53.2 graphenesingle sheet of trigonally bonded (sp2)
36、 carbon atoms in a hexagonal structure2)In preparation.PAS 131:20074 BSI 20074 Structural entities4.1 acicular structureneedle shaped structure4.2 agglomeratecollection of loosely bound particles or aggregates or mixtures of the two where the resulting external surface area is similar to the sum of
37、the surface areas of the individual componentsNOTE The forces holding an agglomerate together are weak forces, for example van der Waals forces, as well as simple physical entanglement.ISO/TS 276873)4.3 aggregateparticle comprising strongly bonded or fused particles where the resulting external surf
38、ace area may be significantly smaller than the sum of calculated surface areas of the individual componentsNOTE The forces holding an aggregate together are strong forces, for example covalent bonds, or those resulting from sintering or complex physical entanglement.ISO/TS 276873)4.4 carbon nanotube
39、nanotube consisting of carbonNOTE This term is commonly used to refer to a seamless tube constructed from graphene that can be either a single-wall carbon nanotube (SWCNT), comprising a single layer of carbon atoms, or a multi-wall carbon nanotube (MWCNT), comprising multiple concentric tubes.4.5 de
40、ndrimerrepeatedly branched macromoleculeNOTE Dendrimers can be configured as a sphere, partial sphere or wedge structure (i.e. dendritic wedge).4.6 dendritic particleparticle with a highly branched structure on its surface and/or in its coreNOTE Also referred to as a branched-chain aggregate.derived
41、 from PAS 71:2005, definition 3.64.7 dendrondendrimer containing a single chemically addressable groupNOTE The single chemically addressable group is known as the focal point.4.8 engineered nanoparticlesnanoparticles deliberately designed and produced to have specific properties or a specific compos
42、itionderived from PAS 71:2005, definition 3.74.9 liposomepolymeric nanoparticle with various targeting ligands attached to its surfaceNOTE The functionality of liposomes means that they can attach to surfaces and accumulate in pathological areas for treatment of disease.3)In preparation. BSI 2007 5P
43、AS 131:20074.10 micelleaggregation of surfactant molecules dispersed in a liquidNOTE 1 The surfactant molecules are often sequestered into hydrophilic and hydrophobic regions.NOTE 2 Micelles are commonly spherical but can also be branched, rods or worm-like.4.11 nanoclusternon covalently or covalent
44、ly bound group of atoms or molecules whose largest overall dimension is in the nanoscale4.12 nanocorenanoscale central part of a structure encapsulated (or coated) in a dissimilar material4.13 nanocrystalnanoscale solid formed with a periodic lattice of atoms, ions or moleculesPAS 71:2005, definitio
45、n 3.154.14 nanofibreflexible nanorodISO/TS 276874)4.15 nanohornnanoscale conePAS 71:2005, definition 3.184.16 nanoplatenano-object with one external dimension in the nanoscale and the two other external dimensions significantly largerNOTE 1 The smallest external dimension is the thickness of the nan
46、oplate.NOTE 2 The two significantly larger dimensions are considered to differ from the nanoscale dimension by more than three times.NOTE 3 The larger external dimensions are not necessarily at the nanoscale.ISO/TS 276874)4.17 nanopowdermass of dry nanoparticles4.18 nanoribbonnanorod flattened in on
47、e of its shorter dimensionsNOTE Also referred to as a nanobelt.4)In preparation.PAS 131:20076 BSI 20074.19 nanorodnano-object with two similar external dimensions in the nanoscale and the third dimension significantly larger than the other two external dimensionsNOTE 1 The largest external dimension
48、 is the length of the nanorod and is not necessarily in the nanoscale.NOTE 2 The two similar external dimensions are considered to differ in size by less than three times and the significantly larger external dimension is considered to differ from the other two by more than three times.NOTE 3 A nano
49、rod can take any cross-sectional shape consistent with the dimensional limits of the definition.ISO/TS 276875)4.20 nanoropenanofibres in a twisted conformation4.21 nanoshellhollow nanoparticleNOTE This is typically used as a delivery vehicle.Nanodictionary 34.22 nanosomeliposome designed at the nanoscaleNOTE Nanosomes are also known as nanoscale liposomes and nanocapsules.4.23 nanotubehollow nanorodISO/TS 276875)4.24 nanowireelongated structure with only two dimensions in the nanoscale and
