前言:这是CAN/CSA-Z902《血液和血液成分》的第四版。它取代了2015年、2010年和2004年出版的之前版本。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。CSA集团已将其作为加拿大国家标准发布。范围:1.1本标准规定了采集、处理、储存和使用人体血液成分进行输血的设施的管理要求。它解决了接受者的安全性、有效性和质量、献血者的安全性、血液成分的管理以及设施人员和其他暴露于血液成分或可能受其影响的人员的安全问题。1.2本标准适用于血液中心、输血服务机构以及收集、处理、储存或使用人体血液成分进行输血的任何其他组织。 1.3本标准还包括血液制品的储存和使用要求，前提是此类产品属于本标准涵盖的组织的责任范围。注:虽然本标准不特别适用于管理血液制品但不管理血液成分的组织（如医院药房），但鼓励这些组织审查血液制品的相关要求，并酌情将其纳入其程序。1.4作为管理标准，本标准无意取代详细规范和操作规程；更确切地说，它是用于他们的准备。它包括政策和程序、质量管理、人员、实体厂房和设备的要求。此外，本标准概述了设施操作程序中关于以下活动的具体要求: a） 异基因血液采集的供体选择；b） 收集用于输血的血液成分；c） 血液成分的制备；d） 血液成分的检测和标签；e） 放行、储存、包装和运输；f） 要求、输血前检测、成分选择和验收标准；g） 输血；h） 自体采血和输血；i） 单采捐献；j） 与设施中使用的血液制品有关的输血服务责任；注:本项指直接通过输血服务管理的血液制品，而不是由其他服务（如药房）管理的血液制品。k） 定向捐赠和指定捐赠；l） 预先评估的捐赠者计划；m） 家庭输血；n） 不良事件监测和纠正措施；o） 从血液供应中去除不安全成分和献血者；p） 记录管理； andq）计算机系统的验证和维护。1.5本标准不包括与a）用于制造血浆产品的血浆收集相关的活动的要求；和b）血液制品的加工、制造或商业分销，包括溶剂洗涤剂血浆。注:用于人用药物生产的血浆受《血液条例》管辖。1.6在本标准中，“应”用于表示要求，即用户为遵守本标准而有义务满足的规定；“应该”用于表示建议或建议但不需要的建议；“可”用于表示一个选项或在标准范围内允许的选项。注释随附条款不包括要求或替代要求；随附条款的注释的目的是将解释性或信息性材料与文本分开。 表和图的注释被视为表或图的一部分，可以作为要求编写。附件被指定为规范性（强制性）或信息性（非强制性）以定义其应用。

Preface:This is the fourth edition of CAN/CSA-Z902,Blood and blood components. It supersedes the previous editions published in 2015, 2010, and 2004.This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.Scope:1.1This Standard provides management requirements for facilities that collect, process, store, and use human blood components for transfusion. It addresses issues of safety, efficacy, and quality for recipients, safety of donors, management of blood components, and safety of facility personnel and others who are exposed to or potentially affected by blood components.1.2This Standard applies to blood centres, transfusion services, and to any other organization that collects, processes, stores, or uses human blood components for transfusion.1.3It also includes requirements for the storage and use of blood products, when such products are within the responsibility of an organization that is covered by this Standard.Note:While this Standard does not specifically apply to organizations that manage blood products but not blood components (e.g., a hospital pharmacy), these organizations are encouraged to review the relevant requirements for blood products and incorporate them as appropriate into their procedures.1.4As a management standard, this Standard is not intended to replace detailed specifications and operating procedures; rather, it is intended for use in their preparation. It includes requirements for policies and procedures, quality management, personnel, physical plant, and equipment. In addition, this Standard outlines specific requirements to be included in the facility's operating procedures for the following activities:a) donor selection for allogeneic blood collection;b) collection of blood components for transfusion;c) preparation of blood components;d) testing and labelling of blood components;e) release, storage, packing, and transportation;f) requests, pre-transfusion testing, selection of components, and acceptance criteria;g) transfusion;h) autologous blood collection and transfusion;i) apheresis donation;j) transfusion service responsibilities regarding blood products used in the facility;Note:This Item refers to blood products that are managed directly through the transfusion service, as opposed to those managed by other services, e.g., the pharmacy.k) directed donations and designated donations;l) pre-assessed donor programs;m) home transfusion;n) adverse event monitoring and corrective action;o) removal of unsafe components and donors from the blood supply;p) record management; andq) validation and maintenance of computer systems.1.5This Standard does not include requirements for activities associated witha) the collection of plasma for use in the manufacture of plasma products; andb) the processing, manufacture, or commercial distribution of blood products, including solvent detergent plasma.Note:Plasma for use in the manufacture of a drug for human use is covered under the Blood Regulations.1.6In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.