11.020.20 - Medical science
ICS 11.020.20 Details
Medical science
Sciences médicales
Medicinske vede
General Information
Frequently Asked Questions
ICS 11.020.20 is a classification code in the International Classification for Standards (ICS) system. It covers "Medical science". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 9 standards classified under ICS 11.020.20 (Medical science). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
IEC TS 63134:2020 identifies AAL scenarios and use cases based on real-world applications and requirements. The use cases provide a practical context for considerations of interoperability and standards based on user experience. Use cases provide a context for utilizing existing standards and identifying further standardization work. User requirements have also been identified.
This document also highlights potential areas for standardization in the AAL environment to ensure safety, security, privacy, ease of operation, performance and interoperability.
Lastly, this document is a contribution to the IEC use case management repository, the purpose of which is to collect, administer, maintain, and analyse use cases.
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- Technical specification238 pagesEnglish languagesale 15% off
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1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to microphysiological systems (MPS). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for MPS.
1.2 The terms and nomenclature presented in this standard are for the specific purpose of unifying the language used in MPS standards and are not intended for labeling of regulated medical products.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document contains the terms, definitions, notes to entry and examples corresponding to the frequently used concepts which apply to diagnostic and therapeutic nuclear medicine. It comprises the minimum essential information for each nuclear medicine concept represented by a single term. It provides the reader with the information required to approach this multidisciplinary speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate communication and promote common understanding.
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SIGNIFICANCE AND USE
5.1 This test method will assess whether the test nanoparticulate material has chemoattractant activity.
5.2 This test method will provide a rapid and quantitative measure of the ability of nanoparticulate material to recruit immune cells.
5.3 Recruitment of immune cells by chemotaxis plays an important part in all phases of both humoral and cell-mediated immune responses.
5.4 Testing the capacity of a nanoparticulate material to recruit immune cells in vitro helps in predicting the influence of such material on the immune cell response.
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1.1 This test method provides a protocol for rapid and quantitative measurement of the chemoattractant capacity of a nanoparticulate material (nanoparticles and their aggregates and agglomerates).
1.2 Immune cells recruitment (by chemotaxis) plays a central role in the immune system function especially in the inflammatory process.
1.3 This test method uses an in vitro model. In this model, peripheral blood human acute promyelocytic leukemia cells HL-60 are separated from control chemoattractant or test nanoparticulate material by a 3-µm pore size filter; the cell migration through the filter is monitored and quantified using the fluorescent dye calcein AM (Figs. 1 and 2).
FIG. 1 Chemotaxis Chamber (Boyden Chamber)
FIG. 2 Chemotaxis Assay
a (left)—Parts of the chemotaxis assay assembly.
b (right)—Procedure for testing the chemoattractant capacity of a nanoparticulate material.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 Decellularization is used in the preparation of medical products that make use of the native structure and/or composition of the extracellular matrix derived from a specific tissue source. Upon implantation or placement, the decellullarized product is commonly intended to undergo and/or induce constructive remodeling and incorporation into the native host tissue instead of being recognized as foreign material. Typically, immune system recognition of foreign material leads to encapsulation of the material and an aggressive inflammatory response, causing the ultimate rejection or other failure of the product.
4.2 As described above, decellularization is a recognized technique which allows the use of ECM-derived products in medical treatments with a reduced risk of an adverse host immune response and immune rejection by disrupting and removing cells and/or cell contents while aiming to preserve significant features of the ECM structure and/or composition. More complete decellularization is often associated with a beneficial response (1, 2)6 but can also be associated with the loss of important ECM components and the loss of structural or biomechanical integrity from the tissue during the decellularization process (3, 4, 5, 6). Therefore, given the typical objective of producing a product that does not elicit an adverse immune response while maintaining the integrity of the tissue for its intended surgical application, this guide presents a standard approach to the evaluation of decellularization processes, including assessment of adequate decellularization to achieve this end.
4.3 An ideal decellularization process would completely remove source tissue cells and associated cellular content from a tissue or organ, while minimizing unwanted effects on the remaining ECM. However, a more widely encountered and practical representation of an optimized decellularization process exhibits partial removal and/or disruption of resident cells and cellular material to le...
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1.1 This document provides guidance on the characterization and evaluation of the decellularization processes used to produce decellularized extracellular matrix (dECM) materials which will be used as medical products in direct or indirect contact with the body. The decellularization process may be performed on tissue from human or other mammalian sources or produced in vitro from human or other mammalian cells. The dECM may or may not be recellularized prior to use. Decellularized ECM material derived from non-mammalian tissue or cells and decellularized ECM material used for non-medical purposes may follow the framework provided but may require additional considerations outside the scope of this document.
1.2 Biological tissues are composed of a structural extracellular matrix (ECM) and embedded cells. The intent of a decellularization process is to disrupt and/or remove cells and cellular components from an ECM material while maintaining key structural and/or compositional properties of the material. Decellularization comprises process steps intended or expected to result or aid in the disruption of source tissue cells and/or removal of cellular content from the material undergoing decellularization. Actions that are intended to rinse or otherwise remove decellularization reagents or by-products should also be considered in that context as part of the decellularization process. Purifications or other isolations of specific ECM components are not considered decellularization and are outside the scope of this document.
1.3 This document describes relevant parameters of decellularization processes used to prepare extracellular matrix materials as medical products.
1.4 This document provides guidance on the measurement of specific and general properties of dECM. This includes both the analysis of cellular material as well as the assessment of the effects of decellularization on dECM properties such as composition...
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SIGNIFICANCE AND USE
5.1 Cell Therapy Products may be used to treat clinical conditions, for example in regenerative medicine (e.g. type I diabetes, acute myocardial infarction, pediatric congenital heart disease, chronic ischemic heart failure, cancer, Crohn’s disease, chronic wound repair, nerve and spinal cord injury, musculoskeletal repair), and may be used for immunotherapy (e.g. graft versus host disease, CAR-T therapy).
5.2 Autologous, allogeneic, and xenogeneic cells may be used to make a product.
5.3 A product may be cells only, cells combined with an inert carrier, cells within an extracellular matrix, or cells within a synthetic scaffold, and will include tissue engineered medical products containing cells.
5.4 Cells may be gene-modified cells.
5.5 Cells may be adult or embryonic stem cells.
5.6 Cells may be minimally manipulated.
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1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of cellular therapy products (CTPs) including genetically modified cells, tissue engineered medical products (TEMPs) and combination products where cell activity is a functional component of the final product.
1.2 This Guide was developed to include input derived from several previously published guidance documents and standards (section 2.4). It is the intent of this Guide is to reflect the current perspectives for CTP potency assays.
1.3 CTPs can provide therapy by localized or systemic treatment of a disease or pathology.
1.4 The products may provide a relatively short therapy, may be transient, or may be permanent and provide long-term therapy.
1.5 The products may be cells alone, cells combined with a carrier that is transient, or cells combined with a scaffold or other components that function in the overall therapy.
1.6 Potency assays may be in-vitro or in-vivo assays designed to determine the potency of a specific product. In-vivo assays are likely to be particularly useful to study the mechanism of action (MOA) of the therapy, but may not be desirable for final product quality control where they may be time-consuming and expensive, and where in-vitro assays may be preferable.
1.7 It is likely that multiple assays, and possibly both in-vitro and in-vivo assays, will be required to provide a broad measure of potency. However, in-vitro assays are likely to be preferred as release assays for products, and so studies to identify potency assays should emphasize in-vitro assays that are correlative or predictive of preclinical or clinical results.
1.8 Potency assays should be developed during the product development cycle and therefore are likely to be more comprehensive at the end of that cycle compared to the beginning of product development and testing. It is recommended that potency assays be developed as early as possible in the product development cycle (Figs. 1 and 2).
FIG. 1 Progressive Implementation of Potency Assays
FIG. 2 Flow Chart for Stages in Product Development Showing When Potency Assays Will Be Developed and Introduced
1.9 Potency measurements are used as part of the testing for cell and cell-based products to demonstrate that product lots meet defined specifications when released for clinical use.
1.10 Shelf life specifications should be developed during the product development process to include potency measurements.
1.11 This standard guide is not intended to apply to drug or gene therapy products. However, genetically modified cell therapies, for example the chimeric antigen receptor-T (CAR-T) cell therapy, which the United States FDA classifies as gene therapy, are applicable.
1.12 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limit...
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SIGNIFICANCE AND USE
5.1 This guide describes markers involved in myoblast differentiation that can be used to screen stem cells to help define myogenic capacity. Stem cells include pluripotent and multipotent stem cells capable of differentiating into several different mesenchymal cells, including skeletal muscle myoblasts.
5.2 To assess myogenesis in cells derived and not derived from muscle, markers are measured to accurately define the changes in transcription and structural proteins that regulate differentiation, fusion, and myotube formation. Discussion of these markers is important to understand why they are recommended.
5.3 Myogenic Differentiation:
5.3.1 Myogenic differentiation is a highly regulated process controlled by paired box (Pax) transcription factors and the myogenic regulatory factor (MRF) family. During early differentiation in adults, myogenic progenitors such as activated satellite cells or myoblasts express Pax3 and Pax7. Pax3 and Pax7 transcription factors switch the cells toward a myogenic fate, and repress myocyte differentiation (2), priming the cell for later MRFs. To form muscle, the family of MRFs is required to terminally differentiate myoblasts and form myofibers. These regulatory proteins belong to a superfamily of basic helix-loop-helix transcription factors that consists of myogenic differentiation factor 1 (Myod1), myogenic factor 5 (Myf5), myogenin (Myog), and myogenic factor 6 (Myf6). In the initial stages of myogenic differentiation, Myod1 and Myf5 are the first MRFs to be expressed, and trigger increased production of Myog and Myf6 (3). Increased intracellular Myog and Myf6 induces terminal differentiation of myoblasts into myocytes, leading to fused myotubes.
5.4 Forming Myotubes:
5.4.1 While myogenic markers describe differentiation, fusion into multinucleated myotubes is an important factor in muscle biology. Myoblasts differentiate into a fusogenic phenotype characterized by multiple fusion markers. One marker of note is m-c...
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1.1 Myogenic differentiation is a process regulated by specific transcription factors and signaling molecules that have been shown to induce a myogenic phenotype. Transcription factors mark the stages of myogenesis and act as benchmarks for use in myogenic assays.
1.2 This guide applies to mammalian cells but does not apply to non-mammalian cells as the myogenic markers for non-mammalian cells can be different than those described here.
1.3 This guide proposes appropriate markers to measure when conducting myogenic differentiation assays. This guide describes the stages for multipotent stem cell differentiation toward myoblasts and myotubes. This guide provides information about the appropriate methods to determine myogenic differentiation. This guide does not provide information about media, supplements, or substrates that drive differentiation toward a myogenic phenotype.
1.4 The purpose of this guide is to act as an aid for work performed in the area of skeletal myogenesis. Using this guide, researchers should be able to understand which skeletal muscle markers are best suited for experiments. This guide will improve consistency for studies of myogenic differentiation of multipotent stem cells by identifying appropriate markers for each stage leading to myocyte differentiation. It should be noted that myoblast differentiation in vitro may not be predictive of results that may be obtained in vivo.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Gu...
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This document is intended for use by parties to the design, development, acquisition, use and monitoring of health-care related information and information systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sciences.
The International System of Units forms the basis for this EN. Units with their associated kinds-of-quantity are arranged in order of dimension in Tables 1, 2 and 4 (Clause 5), and in Annex A.
Different kinds-of-quantity may apply to a given combination of component(s) and system. Often the different quantities are interconvertible and examples of such interconvertibility are given in Annex C.
Tables of conversion factors (Annex A) are provided from units in current use to SI units or their multiples.
To represent the result of a measurement (Clause 6), this EN addresses requirements for the following:
¾ relational operator (Clause 4)
¾ numerical value (Subclause 6.1)
¾ uncertainty of measurement (Subclause 6.2; Annex D)
¾ unit of measurement (Clause 5).
This EN covers the requirements for representation of these data elements in displayed and printed form, and provides an approach for support of languages in non-Roman alphabets (Clause 7).
The scope of this standard is limited to textual representation. Support is not provided for the display or printing of images or graphs.
This standard does not cover the requirements for expression of the results of measurements in speech, speech synthesis or handwriting. It does not cover the form and syntax of requests for clinical measurements, nor detailed aspects of data transmission. It refers the user to other CEN standards that address the detailed specification of the interchange format. It does not address the syntax for recording of natural-language statements about quantities, such as those used in recording information about drugs dispensed or about treatment of patients. It does not cover the units of financial quantitie
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This European Prestandard (ENV) is intended for use by parties to the design, development, acquisition, use and monitoring of health-care related information and information systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sciences.
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