1、BSI Standards Publication Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare PD ISO/TR 17302:2015National foreword This Published Document is the UK implementation of ISO/TR 17302:2015. The UK participation in its preparation was ent
2、rusted to Technical Committee NTI/1, Nanotechnologies. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Br
3、itish Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 76119 5 ICS 07.030 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31
4、 December 2015. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TR 17302:2015 ISO 2015 Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare Nanotechnologies Cadre pour le dveloppement dun voc
5、abulaire didentification des applications de nanotechnologies en sant humaine TECHNICAL REPORT ISO/TR 17302 Reference number ISO/TR 17302:2015(E) First edition 2015-12-15 PD ISO/TR 17302:2015 ISO/TR 17302:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Swit
6、zerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be r
7、equested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TR 17302:2015 ISO/TR 17302:2015(E)For
8、eword iv Introduction v 1 Scope . 1 2 Symbols and abbreviated terms . 1 3 Framework . 1 3.1 General . 1 3.2 The clinical value chain 2 3.2.1 General 2 3.2.2 Prediction and prevention . 3 3.2.3 Diagnosis 4 3.2.4 Therapy 5 3.2.5 Monitoring . 5 4 Terminology development within the clinical value chain
9、6 4.1 General . 6 4.2 Identifying terms in need of definition in the clinical value chain . 7 4.2.1 General 7 4.2.2 Prediction and prevention . 8 4.2.3 Diagnosis 8 4.2.4 Therapy 9 4.2.5 Monitoring . 9 4.2.6 Further identification of potential terms 9 Annex A (informative) Nanomedicine terms as defin
10、ed in current literature .10 Annex B (informative) Nanomedicine ontology and terminology resources 16 Bibliography .18 ISO 2015 All rights reserved iii Contents Page PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation
11、of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical 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. I
12、nternational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those
13、 intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (se
14、e www.iso.org/directives). 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. Details of any patent rights identified during the development of the docu
15、ment will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms an
16、d expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 229, Nanotechnologies.iv ISO 20
17、15 All rights reserved PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) Introduction Terminology related to the use of nanotechnologies in human healthcare is on the rise as research in the field continues to intensify. The heightened focus in medical research on nanotechnologies is reflected by the number
18、 of medical and related scientific journals that are reporting on this research. The number of publications mentioning both nanotechnology and biology or medicine has increased logarithmically since approximately the year 2000. 1 This Technical Report explains current concepts related to human healt
19、hcare in the clinical setting and identifies pertinent and timely categories most likely to be advanced by nanotechnologies. Certain aspects of human healthcare are expected to be advanced by nanotechnologies more than others, and standardization needs unique vocabulary to support the development of
20、 applications of nanotechnologies within it. It is recognized, for example, that physical chemists use the term “substrate” to describe a material surface supporting adsorption processes; this differs from a biologists use of the term “substrate” to describe a substance that an enzyme acts upon. Due
21、 to the keen public interest in the advancement of human healthcare, a common vocabulary is particularly relevant to the development of research proposals to gain funding and to communicate findings and results. This Technical Report provides a taxonomic framework to serve as the basis for the devel
22、opment of terminology related to the application of nanotechnologies in human healthcare. The framework identifies categories associated with the clinical value chain most likely to be advanced by nanotechnologies and describes some of the promising technologies being developed and utilized within t
23、he clinical workflow. It is intended that terms will be identified and harmonized definitions will be developed for them within the framework offered by this Technical Report. ISO 2015 All rights reserved v PD ISO/TR 17302:2015 Nanotechnologies Framework for identifying vocabulary development for na
24、notechnology applications in human healthcare 1 Scope This Technical Report will not attempt a formal, comprehensive definition of “nanomedicine”. Instead, it will provide a taxonomic framework for the development of vocabulary for clinical applications of nanotechnologies in human healthcare. While
25、 it is understood that the origins of nanotechnologies for healthcare applications emerge from pre-clinical and translational research, the interest of this Technical Report is to determine where these technologies will impact the clinical value chain and the practice of medicine. This Technical Rep
26、ort is intended to facilitate communications between developers and users of nanotechnologies, deliverers and users of medicine including the pharmaceutical, research and medical communities, regulatory professionals, and additional organizations and individuals who might interact with these groups,
27、 including biotechnology, diagnostic, and medical device companies, the life sciences, patent attorneys and patent offices, institutional review boards, ethics review boards, and accreditation organizations. 2 Symbols and abbreviated terms nm nanometer 3 Framework 3.1 General The term “nanomedicine”
28、 is used by the scientific community and government agencies to describe a field that is relatively undefined in terms of the affected health care segments and the specific advances in nanotechnologies for biomedical applications. In addition, the relevant mechanisms currently associated with diagno
29、sis and treatment in biological processes can be larger than approximately 100 nm (e.g. endocytosis). Several participants from the biological sciences work with 400 nm diameter particles as drug carriers, while others consider 1 000 nm or 500 nm as pertinent in exploring emerging applications. Over
30、all, the products currently enabled by nanotechnologies that are available for commercial clinical use are characterized by in vitro bulk properties or systemic effects. Examples of nanosize objects of interest in healthcare applications are depicted in Figure 1. TECHNICAL REPORT ISO/TR 17302:2015(E
31、) ISO 2015 All rights reserved 1 PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) a) Polymer-drug conjugate b) Polymeric nanoparticle c) Solid lipid nanoparticle d) Dendrimer e) Liposome f) Micelle g) Gold nanoparticle h) Carbon nanotube Key therapeutic agent hydrophilic linker diagnostic agent targeting m
32、oiety Figure 1 Examples of nanosize objects of interest in healthcare applications 2 In contrast, the current ISO definition of the term “nanoscale” stems from materials science and expresses in part the size range associated with quantum effects. The broad, enabling nature of nanotechnologies means
33、 that convergence with the biological sciences will continue to intensify. However, this Technical Report does not seek to suggest that current definitions in nanotechnologies, such as the approximately 100 nm upper boundary found in the ISO definition of the term “nanoscale”, 3be normalized to acco
34、unt for all size relationships in biological systems. 3.2 The clinical value chain 3.2.1 General In recognition of the advancements that are anticipated in the clinical practice of medicine associated with nanotechnologies, relevant applications of nanotechnologies in human healthcare can be identif
35、ied by their location in the clinical value chain (see Figure 2). Figure 2 The clinical value chain The clinical value chain suggested for use in this Technical Report consists of 4 segments. The prediction and prevention segment includes nanotechnologies that are used to predict, or prevent 2 ISO 2
36、015 All rights reserved PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) disease, conduct disease screening, and which are used in disease surveillance. The diagnosis segment includes nanotechnologies that are used for in vitro and in vivo detection, classification, grading, etc. of disease. The therapy se
37、gment includes nanotechnologies that are associated with therapy for disease. This includes drugs and other medicines (e.g. biopharmaceuticals), surgical implants, materials, devices, and surgical aids, and alternative therapies (e.g. stem cells). The monitoring segment includes nanotechnologies tha
38、t are used to monitor disease after therapy to evaluate the efficacy of treatment and the progression or remission of disease, recurrence, side effects, etc. Underlying these segments are pre-clinical and translational activities. That is, fundamental nanotechnology developments in academia, life sc
39、ience, and the biopharmaceutical industry are undertaken with the objective of having an eventual impact or application in one or more of the clinical value chain segments. These might be nanotechnologies used to understand basic life processes or nanotechnologies that support products used in a cli
40、nical setting (see Figure 3). Figure 3 Illustrative example of the general stages of development for nanotechnologies used in medicine, which highlights the European Unions approach 4 3.2.2 Prediction and prevention Prediction and prevention inlcudes technologies that permit accurate screening to id
41、entify the risk or susceptibility to disease or disease recurrence, prognosis based on one or more indicators, public health surveillance of disease and immunization to prevent disease. Products enabled by nanotechnologies in this value chain segment include sprays, coatings, antiseptics and vaccine
42、s. Two application areas that are useful to highlight the contribution of nanotechnologies to this segment of the clinical value are the prevention of surgical site infections and the use of informatics to predict and reduce drug side effects by identifying patients at risk. Surgical site infections
43、 encompass inadvertent infections occurring inside the hospital or physicians office, the prevention of which can include the use of disinfectants, sterile surfaces, protective gowns, air handling, and appropriate waste disposal. The use of nanotechnologies for preventing adventitious infections mig
44、ht be the source of new terms, e.g. “nanotextured surface” to describe a product designed by the coating industry to ensure a sterile environment. Bioinformatics and nano-informatics might be used to evaluate disease prevalence, drug design, acceptable test protocols, dose metrics, and toxicity. ISO
45、 2015 All rights reserved 3 PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) 3.2.3 Diagnosis Nanotechnologies for diagnostics encompass in vivo as well as ex vivo/in vitro evaluations. Nanotechnologies can be used to advance sensing systems to improve the accurate and early detection and diagnosis of disea
46、se. There are multiple components in the diagnostic process ranging from the manufacturing setting (e.g. reagent and detection systems) to the selection of target analytes (e.g. cells, proteins, tissue structures) and the organism setting (in vitro/ex vivo or in vivo) (see Figure 4). Figure 4 Overvi
47、ew of nanotechnologies in diagnostics For example, when a new nanoparticle is developed for in vivo imaging, this diagram approach could be applied to understand the application area and technology as follows (Figure 5): Manufacture Method of synthesis of the nanoparticle. Further details could be a
48、dded, such as additional nanotechnology that is required for the manufacturing process. Source Context of use of the nanoparticle. In this case, the nanoparticle is designed to image a living patient. Measurand This nanoparticle is designed to be delivered into and enhance the visualization of the p
49、atients lymphatics. Sensing System The actual diagnostic action occurs with placement of the patient in the MRI device and detecting the nanoparticles with the lymphatics. Application The goal of the use of the nanoparticle is for the detection of metastatic cancer in the patients lymphatics.4 ISO 2015 All rights reserved PD ISO/TR 17302:2015 ISO/TR 17302:2015(E) Figure 5 Example of understanding a diagnostic application for terminology development 3.2.4 Therapy Applications of nanotechnolog
