1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDD ISO/TS 80004-7:2011Nanotechnologies V o c a b u l a r y Part 7: Diagnostics and therapeutics for healthcareDD ISO/TS 80004-7:2011 DRAFT FOR DEVELOPMENTNational forewordThis Dr
2、aft for Development is the UK implementation of ISO/TS80004-7:2011.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publicationsand is of a provisional nature. It should be applied on thisprovisional basis, so that information and
3、 experience of its practicalapplication can be obtained.Comments arising from the use of this Draft for Developmentare requested so that UK experience can be reported to theinternational organization responsible for its conversion toan international standard. A review of this publication willbe init
4、iated not later than 3 years after its publication by theinternational organization so that a decision can be taken on itsstatus. Notification of the start of the review period will be made inan announcement in the appropriate issue of Update Standards.According to the replies received by the end of
5、 the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sentto the Secretary of the responsible BSI Technical Committee at BritishStandards Hou
6、se, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to TechnicalCommittee NTI/1, Nanotechnologies.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessar
7、yprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 66574 5ICS 01.040.07; 01.040.11; 07.030; 11.040.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This Draft for Development was published under the authority ofthe Sta
8、ndards Policy and Strategy Committee on 31 October 2011.Amendments issued since publicationDate Text affectedDD ISO/TS 80004-7:2011Reference numberNumro de rfrenceISO/TS 80004-7:2011(E/F)ISO 2011TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE ISO/TS80004-7First editionPremire dition2011-10-01Nanotech
9、nologies Vocabulary Part 7: Diagnostics and therapeutics for healthcare Nanotechnologies Vocabulaire Partie 7: Diagnostics et thrapies pour les soins de sant DD ISO/TS 80004-7:2011ISO/TS 80004-7:2011(E/F) COPYRIGHT PROTECTED DOCUMENT DOCUMENT PROTG PAR COPYRIGHT ISO 2011 All rights reserved. Unless
10、otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. / Droits
11、 de reproduction rservs. Sauf prescription diffrente, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de lISO ladresse ci-aprs ou du comit mem
12、bre de lISO dans le pays du demandeur. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland/Publi en Suisse ii ISO 2011 All rights reserved/Tous droits rservsDD ISO/TS 80004-7:2011ISO/TS 8
13、0004-7:2011(E/F) ISO 2011 All rights reserved/Tous droits rservs iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technica
14、l committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely wit
15、h the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft Inter
16、national Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for
17、such documents, a technical committee may decide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the p
18、arent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in
19、order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be
20、 withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 80004-7 was prepared jointly by Technical Committee ISO/TC 229, Nanotechnologies,
21、and Technical Committee IEC/TC 113, Nanotechnology Standardization for electrical and electronic products. ISO/TS 80004 consists of the following parts, under the general title Nanotechnologies Vocabulary: Part 1: Core terms Part 3: Carbon nano-objects Part 5: Nano/bio interface Part 7: Diagnostics
22、and therapeutics for healthcare The following parts are under preparation: Part 2: Nano-objects: Nanoparticle, nanofibre and nanoplate1) Part 4: Nanostructured materials Part 6: Nanoscale measurement and instrumentation Part 8: Nanomanufacturing processes 1) ISO/TS 27687:2008 will be revised as ISO/
23、TS 80004-2. DD ISO/TS 80004-7:2011ISO/TS 80004-7:2011(E/F) iv ISO 2011 All rights reserved/Tous droits rservsAvant-propos LISO (Organisation internationale de normalisation) est une fdration mondiale dorganismes nationaux de normalisation (comits membres de lISO). Llaboration des Normes internationa
24、les est en gnral confie aux comits techniques de lISO. Chaque comit membre intress par une tude a le droit de faire partie du comit technique cr cet effet. Les organisations internationales, gouvernementales et non gouvernementales, en liaison avec lISO participent galement aux travaux. LISO collabo
25、re troitement avec la Commission lectrotechnique internationale (CEI) en ce qui concerne la normalisation lectrotechnique. LISO (Organisation internationale de normalisation) est une fdration mondiale dorganismes nationaux de normalisation (comits membres de lISO). Llaboration des Normes internation
26、ales est en gnral confie aux comits techniques de lISO. Chaque comit membre intress par une tude a le droit de faire partie du comit technique cr cet effet. Les organisations internationales, gouvernementales et non gouvernementales, en liaison avec lISO participent galement aux travaux. LISO collab
27、ore troitement avec la Commission lectrotechnique internationale (CEI) en ce qui concerne la normalisation lectrotechnique. Les Normes internationales sont rdiges conformment aux rgles donnes dans les Directives ISO/CEI, Partie 2. La tche principale des comits techniques est dlaborer les Normes inte
28、rnationales. Les projets de Normes internationales adopts par les comits techniques sont soumis aux comits membres pour vote. Leur publication comme Normes internationales requiert lapprobation de 75 % au moins des comits membres votants. Dans dautres circonstances, en particulier lorsquil existe un
29、e demande urgente du march, un comit technique peut dcider de publier dautres types de documents: une Spcification publiquement disponible ISO (ISO/PAS) reprsente un accord entre les experts dans un groupe de travail ISO et est accepte pour publication si elle est approuve par plus de 50 % des membr
30、es votants du comit dont relve le groupe de travail; une Spcification technique ISO (ISO/TS) reprsente un accord entre les membres dun comit technique et est accepte pour publication si elle est approuve par 2/3 des membres votants du comit. Une ISO/PAS ou ISO/TS fait lobjet dun examen aprs trois an
31、s afin de dcider si elle est confirme pour trois nouvelles annes, rvise pour devenir une Norme internationale, ou annule. Lorsquune ISO/PAS ou ISO/TS a t confirme, elle fait lobjet dun nouvel examen aprs trois ans qui dcidera soit de sa transformation en Norme internationale soit de son annulation.
32、Lattention est appele sur le fait que certains des lments du prsent document peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. LISO ne saurait tre tenue pour responsable de ne pas avoir identifi de tels droits de proprit et averti de leur existence. LISO/TS 80004-7 a t
33、 labore par le comit technique ISO/TC 229, Nanotechnologies et le comit technique CEI/TC 113, Nanotechnologies Normalisation des produits et des systmes lectriques et lectroniques. DD ISO/TS 80004-7:2011ISO/TS 80004-7:2011(E/F) ISO 2011 All rights reserved/Tous droits rservs vLISO/TS 80004 comprend
34、les parties suivantes, prsentes sous le titre gnral Nanotechnologies Vocabulaire: Partie 1: Termes cur Partie 3: Nano-objets en carbone Partie 5: Interface nano/bio Partie 7: Diagnostics et thrapies pour les soins de sant Les parties suivantes sont en cours dlaboration: Partie 2: Nano-objets: Nanopa
35、rticule, nanofibre et nanofeuillet2) Partie 4: Matriaux nanostructurs Partie 6: Instrumentation et mesurage lchelle nanomtrique Partie 8: Processus de nanofabrication 2) LISO/TS 27687:2008 sera rvise en tant que ISO/TS 80004-2. DD ISO/TS 80004-7:2011ISO/TS 80004-7:2011(E/F) vi ISO 2011 All rights re
36、served/Tous droits rservsIntroduction Developments in the design and fabrication of nanomaterials have led to a significant change in the way materials are being explored and re-explored within engineering and the physical sciences. Similar developments are anticipated in the healthcare sector, wher
37、e the capability for diagnosis and therapy, respectively, are set to be substantially augmented by nanoscale components. These might be components within a larger construct, such as a biomaterial or nanocomposite, or directly deployed as free nanoscale structures. The exploitation of nanoscale parti
38、cles or surface properties for diagnostic or therapeutic purposes in relation to human disease comes within the scope of medical products and devices. This practical application of nanomaterials, referred to as nanomedicine, comes within the general domain of healthcare. Any biological system at the
39、 cellular level operates at the nanoscale and exhibits a self-organizing functionality that constitutes a fundamental building block for the more structurally familiar macroscale. This latter scale includes the lipid bilayer of the cell membrane, cell organelles and supra-macromolecular constructs d
40、esigned variously for affinity binding, catalysis and motility. Relevant properties of nanoscale particles or surfaces can be utilised in vivo or in vitro. DD ISO/TS 80004-7:2011ISO/TS 80004-7:2011(E/F) ISO 2011 All rights reserved/Tous droits rservs viiIntroduction Lvolution de la conception et de
41、la fabrication des nanomatriaux a conduit modifier de manire significative la faon dont les matriaux sont explors et r-explors en ingnierie et en sciences physiques. On anticipe des volutions similaires dans le secteur des soins de sant, o les capacits de diagnostic et de thrapie, respectivement, so
42、nt largement accrues grce aux composants lchelle nanomtrique. Ces composants peuvent faire partie dune structure plus grande, comme un biomatriau ou un nanocomposite, ou tre directement dploys en tant que nanostructures libres. Lexploitation des proprits des nanoparticules ou des surfaces nanostruct
43、ures des fins thrapeutiques ou de diagnostic en relation avec les pathologies humaines entre dans le champ des produits et dispositifs mdicaux. Cette application pratique des nanomatriaux, connue sous le nom de nanomdecine, fait partie du domaine gnral des soins de sant. Tout systme biologique prsen
44、t au niveau cellulaire fonctionne lchelle nanomtrique et prsente une fonctionnalit dauto-organisation qui constitue une brique lmentaire pour construire la structure macroscopique plus familire. Cette brique comprend la bicouche lipidique de la membrane cellulaire, les organites cellulaires et les d
45、ifices supra-macromolculaires conus de manire diverse pour des fonctions de liaison daffinit, de catalyse et de motilit. Les proprits pertinentes des nanoparticules ou des surfaces nanostructures peuvent tre exploites in vivo ou in vitro. DD ISO/TS 80004-7:2011DD ISO/TS 80004-7:2011TECHNICAL SPECIFI
46、CATION SPCIFICATION TECHNIQUE ISO/TS 80004-7:2011(E/F) ISO 2011 All rights reserved/Tous droits rservs 1Nanotechnologies Vocabulary Part 7: Diagnostics and therapeutics for healthcare Nanotechnologies Vocabulaire Partie 7: Diagnostics et thrapies pour les soins de sant 1 Scope 1 Domaine dapplication
47、 This part of ISO/TS 80004 is applicable to the use of nanotechnologies in medical diagnostics and therapeutics. Terms relating to the applications of nanotechnology in healthcare might also be addressed in other parts of ISO/TS 80004 and in other documents. Terms relating to the exploitation of mat
48、erial features at the nanoscale for diagnostic or therapeutic purposes in relation to human disease come within the scope of this part of ISO/TS 80004. Nanoscale properties can be embodied in materials that contain nanoscale elements, or are themselves of nanoscale dimensions. This part of ISO/TS 80004 does not address: terms relating to the biological consequences of a nanomaterial, regardless of the nanomaterials original purpose, or terminology describing health, safety and environmental consequences. This part of ISO/TS 80
