序言这是CSA Z314的第五版。2、通过环氧乙烷工艺对医疗设施进行有效消毒。它取代了2001年、1991年、1984年和1977年出版的先前版本。它是CSA关于医疗用品和设备安全有效灭菌的一系列标准之一。范围1。1本标准规定了实施使用环氧乙烷对医疗设施中的医疗设备进行消毒的计划的基本要素，目的是实现充分的无菌保证水平，并将医疗设施人员和患者受伤的风险降至最低。 注:（1）“卫生保健设施”一词包括但不限于医院、养老院、扩展护理设施、诊所、医疗和牙科办公室以及行业内的卫生单位。（2） CSA PLUS 1112.1.2中提供了小型办公设施的综合指南。该标准包括（a）政策、程序和文件要求；（b） 人员资格和培训；（c） 质量体系；（d） 评估和购买可重复使用的医疗器械；（e） 工作区域和设备；（f） 需要消毒的医疗器械的制备和包装； （g） 灭菌器装载和操作；（h） 灭菌后曝气；（i） 无菌医疗器械的储存；（j） 无菌保证，包括过程挑战装置（PCD）的构造和使用；以及（k）维护和消毒器质量保证。注:PCD已取代术语“测试包”。1.3本标准不适用于（a）制造商对环氧乙烷灭菌器的结构和性能的要求；注:见CSA Z314。1.（b）环氧乙烷灭菌器的安装和通风；注:见CSA Z314。9.（c）消毒前对可重复使用的医疗器械进行去污； 注:见CSA Z314。8.（d）一次性/一次性医疗器械；注:加拿大医疗保健协会（1996年）和ECRI研究所（1997年）等出版物中提供了与重复使用此类设备有关的安全、技术、成本/效益和法律问题的信息。（e） 用于已知或怀疑患有克雅氏病（CJD）或朊病毒相关疾病的患者的医疗设备。注:见加拿大卫生部（2007）。1.4在CSA标准中，“应”用于表示要求，即用户有义务满足的条款，以符合标准； “应该”用于表示建议或建议但不需要的建议；“可”用于表示一种选择或在标准范围内允许的选择；“can”用来表示可能性或能力。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）- 必须）定义其应用程序。

PrefaceThis is the fifth edition of CSA Z314.2, Effective sterilization in health care facilities by the ethylene oxide process. It supersedes the previous editions, published in 2001, 1991, 1984, and 1977. It is one of a series of CSA Standards dealing with the safe and effective sterilization of medical supplies and equipment.Scope1.1This Standard specifies essential elements in implementing a program for using ethylene oxide to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care facility personnel and patients.Notes:(1) The term "health care facility" includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.(2) Comprehensive guidance for small, office-based facilities can be found in CSA PLUS 1112.1.2This Standard includes requirements for(a) policies, procedures, and documentation;(b) personnel qualifications and training;(c) quality system;(d) evaluation and purchase of reusable medical devices;(e) work areas and equipment;(f) preparation and packaging of medical devices requiring sterilization;(g) sterilizer loading and operation;(h) aeration following sterilization;(i) storage of sterilized medical devices;(j) sterility assurance, including process challenge device (PCD) construction and use; and(k) maintenance and sterilizer quality assurance.Note: PCD has replaced the term "test pack".1.3This Standard does not apply to(a) manufacturers' requirements for construction and performance of ethylene oxide sterilizers;Note: See CSA Z314.1.(b) installation and ventilation of ethylene oxide sterilizers;Note: See CSA Z314.9.(c) decontamination of reusable medical devices prior to sterilization;Note: See CSA Z314.8.(d) single-use/disposable medical devices; orNote: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such devices is found in such publications as the Canadian Healthcare Association (1996) and ECRI Institute (1997).(e) medical devices that have been used with patients who are known or suspected to have Creutzfeldt-Jakob Disease (CJD) or prion-related diseases.Note: See Health Canada (2007).1.4In CSA Standards, "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; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. 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.