1.1 本指南定义了术语，并确定了用于组织工程医疗产品（TEMPS）或细胞治疗应用的自体富血小板血浆（PRP）和PRP衍生血小板凝胶的关键基本特性。本指南为描述PRP和血小板凝胶的显著特性和加工参数提供了一个通用的术语和基础，可能对制造商、研究人员和临床医生有用。还提供了关于PRP处理技术、表征和质量保证的某些方面的进一步讨论，以及这些考虑因素如何影响关键特性。本指南中概述的PRP特征是基于对当代科学和临床文献的回顾而选择的，但不一定代表一个全面的清单； 其他重要的未知特性可能存在，或在未来的科学评估中被揭示。本指南基于广泛的实用性，为如何识别和引用PRP的相关特征提供了一般建议；然而，本标准的用户应查阅参考文件，以获取有关特定背景下任何特定PRP特征的相对重要性或重要性的更多信息。 1.2 本指南的范围仅限于从自体人类外周血中提取和加工的PRP和血小板凝胶的各个方面。本标准范围内定义的富血小板血浆可能包括白细胞。 1.3 本文件的范围仅限于用于TEMPS或细胞治疗应用的PRP和血小板凝胶的指导。 用于直接静脉输液的PRP、其他血小板浓缩液或其他血液成分的处理不在本指南的范围内。输血医学中使用的单采血小板和其他血小板浓缩物不在本文件范围内。用于与用于TEMPS或细胞治疗的PRP无关的诊断或研究应用的PRP或血小板凝胶的生产也不在本指南的范围内。不含血小板的纤维蛋白凝胶也排除在本文的讨论之外。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 4.1 自体PRP和血小板凝胶广泛应用于骨科、运动医学、再生医学和外科应用 ( 3. 5. ) PRP和血小板凝胶单独或与移植物材料或TEMP结合，分层、喷涂、注射、模制或包装到各种解剖部位、组织和空隙中 ( 3. , 6. ) 这些血小板浓缩物可以提供各种生物活性分子、细胞和物理特性，这些特性对于促进愈合和其他细胞治疗应用具有潜在的吸引力 ( 7. ) 不幸的是，术语“富血小板血浆”或“PRP”在与各种血小板浓缩物相关的早期和当代医学文献中无处不在，它只明确表示血小板悬浮液的一个关键参数——血小板浓度增加。在没有进一步背景的情况下，这种对PRP的常见描述无法提供有关血小板浓度的其他重要物理和细胞方面的信息。随着对PRP和其他细胞疗法的科学和临床理解的增加，命名和术语的标准化对于定义关键特性、标准化处理参数和技术以及开发可重复的检测方法以进行质量保证和科学评估至关重要 ( 5. , 8. 13 ) 本指南概述了以标准化方式描述独特PRP和血小板凝胶制剂关键特性的基本指南。 可靠、标准化的描述可以为PRP最终用户提供有价值的背景，例如临床医生寻求具有某些生物学属性的PRP或血小板凝胶，或者科学研究人员寻求复制已发表的制剂，或者将给定的PRP或者血小板凝胶特征与其他生物学特性或结果相关联。

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 on 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 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. ====== Significance And Use ====== 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.