4.1 Autologous PRP and platelet gels are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, and surgical applications (3-5). PRP and platelet gels are layered, sprayed, injected, molded, or packed, alone or in combination with graft material or TEMPs, into a variety of anatomical sites, tissues, and voids (3, 6). These platelet concentrates can provide an assortment of bioactive molecules, cells, and physical properties that are potentially attractive for promoting healing and other cell therapy applications (7). Unfortunately, the term “platelet-rich plasma” or “PRP,” which is ubiquitous in early and contemporary medical literature related to a variety of platelet concentrates, only unambiguously denotes one critical parameter of a platelet suspension—increased platelet concentration. Without further context, this common description of PRP offers no information about other important physical and cellular aspects of platelet concentrations. As scientific and clinical understanding of PRP and other cellular therapies increases standardization of nomenclature and terminology is critical for defining key properties, standardizing processing parameters and techniques, and developing repeatable assays for quality assurance and scientific evaluation (5, 8-13). This guide outlines basic guidelines to describe key properties of unique PRP and platelet gel formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP or platelet gel with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP or platelet gel feature to other biological properties or outcomes.1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP) and PRP-derived platelet gels intended to be used for tissue engineered medical products (TEMPS) or for cell therapy applications. This guide provides a common nomenclature and basis for describing notable properties and processing parameters for PRP and platelet gels that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of PRP processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The PRP characteristics outlined in this guide were selected based n a review of contemporary scientific and clinical literature but do not necessarily represent a comprehensive inventory; other significant unidentified properties may exist or be revealed by future scientific evaluation. This guide provides general recommendations for how to identify and cite relevant characteristics of PRP, based on broad utility; however, users of this standard should consult referenced documents for further information on the relative import or significance of any particular PRP characteristic in a particular context.1.2 The scope of this guide is confined to aspects of PRP and platelet gels derived and processed from autologous human peripheral blood. Platelet-rich plasma, as defined within the scope of this standard, may include leukocytes.1.3 The scope of this document is limited to guidance for PRP and platelet gels that are intended to be used for TEMPS or for cell therapy applications. Processing of PRP, other platelet concentrates or other blood components for direct intravenous transfusion is outside the scope of this guide. Apheresis platelets and other platelet concentrates utilized in transfusion medicine are outside the scope of this document. Production of PRP or platelet gels for diagnostic or research applications unrelated to PRP intended for TEMPS or cell therapy is also outside the scope of this guide. Fibrin gels devoid of platelets are also excluded from discussion within this document.1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

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1. Scope 1.1 This Standard applies to diagnostic imaging and radiation therapy equipment designed to be (a) installed and used in accordance with the Canadian Electrical Code, Part I while connected to supply circuits with nominal system voltages of 750

定价： 1001元 / 折扣价： 851 元

定价： 546元 / 折扣价： 465 元

定价： 1092元 / 折扣价： 929 元

定价： 1183元 / 折扣价： 1006 元

1 Scope This Particular Standard specifies requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT, having a RATED OUTPUT POWER not exceeding 500 W. This equipment shall be des

定价： 410元 / 折扣价： 349 元

No Scope Available

定价： 1183元 / 折扣价： 1006 元

1 Scope This Particular Standard specifies requirements for the safety of MICROWAVE THERAPY EQUIPMENT as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT designed to be installed and used in accordance with the Rules of the Canadian

定价： 319元 / 折扣价： 272 元

1 Scope and Object This clause of the General Standard applies as follows: 1.1 Scope Addition: aa) This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY EQUIPMENT intended for RADIOTHERAPY in human medical pract

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This amendment is applicable to equipment for multi-source STEREOTACTIC treatment including radiosurgery and RADIOTHERAPY (MSSR). STEREOTAXIS is defined as a method for locating points within the human body using an external three-dimensional frame of ref

定价： 455元 / 折扣价： 387 元

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.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 AssaysFIG. 2 Flow Chart for Stages in Product Development Showing When Potency Assays Will Be Developed and Introduced1.9 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 limitations prior to use.1.13 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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