1.1 本安全规范规定了成人便携式床轨、相关产品和成人便携式床栏杆配件的性能要求，包括防夹性、标记和粘贴标签、教学资料和广告的要求。 1.2 本标准适用于任何此类产品（定义如下），这些产品不是由床制造商设计为床的一部分，而是安装在成人床的侧面、靠着或靠近成人床的一侧，供成人使用，以降低从床上跌落的风险，帮助在床上重新定位，帮助转换到床上或从床上转换出来，或制造商规定的其他类似用途。 1.3 本安全规范包括符合医疗器械定义并因此受美国食品药品监督管理局（FDA）管辖的成人便携式床轨，以及非医疗器械并因此受消费品安全委员会（CPSC）管辖的成年人便携式床轨。 2. 1.4 本安全规范不包括美国食品药品监督管理局规定的病床上使用的护栏或侧栏，也不包括消费者安全规范中包含的儿童便携式护栏 F1821 幼儿床，消费者安全规范 F2085 用于儿童的便携式床轨，或用于医疗床的IEC 60601-2-52。 1.5 本安全规范旨在最大限度地减少由设计部件引起的截留和勒死危险，无论这些危险是由正常安装和使用、合理可预见的错误安装/误用、或随时间推移附件稳定性的变化或其组合引起的。可能存在不在本规范范围内的其他危险（例如跌倒）。此类危险将成为附加标准的主题。 1.6 成人便携式床轨或本规范中定义的相关产品，除非符合本规范中的所有要求，否则不得通过标签或其他方式表明符合本规范。 1.7 单位-- 以英寸磅为单位的数值应视为标准。括号中给出的值是国际单位制的数学转换，仅供参考，不被视为标准。 1.8 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 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。

1.1 This safety specification establishes performance requirements for adult portable bed rails, related products, and adult portable bedrail accessories, including requirements for resistance to entrapment, marking and adhered labels, instructional literature, and advertising. 1.2 This standard is applicable to any such product (as defined below) that is not designed as part of the bed by the bed manufacturer, and is installed on, against, or adjacent to the side of an adult bed and is for use by adults to reduce the risk of falling from the bed, assist in repositioning in the bed, assist in transitioning into or out of the bed, or other similar purposes as stated by the manufacturer. 1.3 This safety specification includes adult portable bed rails that meet the definition of a medical device and are therefore under the jurisdiction of the Food and Drug Administration (FDA), and adult portable bed rails that are not medical devices, and which therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC). 2 1.4 This safety specification does not cover guardrails or side rails intended for use on FDA regulated hospital beds, or portable rails for children which are included in Consumer Safety Specification F1821 for toddler beds, Consumer Safety Specification F2085 for portable bed rails for children, or IEC 60601-2-52 for medical beds. 1.5 This safety specification is intended to minimize entrapment and strangulation hazards that are attributed to design components, whether these hazards arise from normal installation and use, reasonably foreseeable mis-installation/misuse, or changes to the stability of the attachment over time, or combinations thereof. Other hazards may exist (for example, falls) that are not within the scope of this specification. Such hazards will be the subject of additional standards. 1.6 No adult portable bed rail, or related product as defined in this specification, shall, either by label or other means, indicate compliance with this specification unless it conforms to all the requirements contained herein. 1.7 Units— The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversion to SI units that are provided for information only and are not considered standard. 1.8 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. 1.9 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.