1.1 本标准指南涉及医疗设备的退役和处置。 1.2 当设备因过时而不再需要、无法操作或已达到预定更换里程碑时，医疗设备的退役和处置完成。退役是处置过程中的第一个物理过程，包括正确识别、授权处置和消毒设备，以及删除患者健康信息（PHI）或软件，或两者。处置方法取决于本标准指南中描述的许多因素。 1.3 本指南不包括针对任何监管机构或实体可能经营的各级政府的详细处置方法程序或销售要求或限制。 本指南还提供了许多操作通用的实践，并提供了最佳集成外部需求的灵活性。 1.4 虽然本标准描述了与医疗设备退役和处置相关的常见安全和环境考虑因素，但并不旨在解决与其使用相关的所有安全问题（如有）。使用本标准的实体有责任建立和应用适当的安全、健康和环境实践，并在使用前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（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本指南确定了安全退役和处置医疗设备的常见流程。目标是确定医疗设备特有的常见挑战，以帮助确保在处置团队参与该过程之前完成设备的识别、处置授权和适当的卫生处理。 5.2 本指南提供了在选择处置方案以有效管理实体资产时需要考虑的信息。

1.1 This standard guide addresses decommissioning and disposal of medical equipment. 1.2 Decommissioning and disposal of medical equipment is done when equipment is no longer needed due to obsolescence, is inoperable, or has met a scheduled replacement milestone. Decommissioning is the first physical process in the disposition process and includes proper identification, authorization for disposition, and sanitization of the equipment, as well as removal of Patient Health Information (PHI) or software, or both. Disposal method is dependent upon many factors that will be described in this standard guide. 1.3 This guide does not include detailed disposal method procedures or sales requirements or restrictions specific to any regulatory body or the various levels of government in which an entity may operate. This guide also provides practices that are common to many operations and provides flexibility to best integrate external requirements. 1.4 While this standard describes common safety and environmental considerations associated with the decommissioning and disposal of medical equipment, it does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the entity using this standard to establish and apply 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 ====== 5.1 This guide identifies common processes to safely decommission and dispose of medical equipment. The objective is to identify common challenges unique to medical equipment to help ensure that the identification, authorization for disposition, and proper sanitization of the equipment is completed prior to disposal teams getting involved in the process. 5.2 This guide provides information to consider when choosing disposal options in order to effectively manage the entity’s assets.