1.1 本指南列出了外骨骼生产者在分析和管理与外骨骼相关的潜在风险时应考虑的典型危险。 1.2 在可能的情况下，本指南提供了机构标准、法规或指南的参考，以评估与这些危险相关的风险，并应用风险降低措施。 1.3 本指南适用于所有外骨骼类型，不考虑技术的应用，如消费者、工业、医疗、军事和应急管理服务。 1.4 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户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。 1.6 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====== 4.1 外骨骼技术的发展需要仔细分析可能与其使用相关的潜在风险。未能充分评估风险可能会在外骨骼使用的许多情况下导致危险情况，例如在完成人体试验期间、在贸易展览中展示外骨骼期间以及在外骨骼训练、穿戴、操作、运输、维护和处置期间。 4.2 本指南提供了生产商在分析和减轻与外骨骼相关的风险时应考虑的一组最小危害。这组危险应辅以其他可能反映与外骨骼技术和应用相关的独特安全问题的危险。以下来源可以提供基于外骨骼技术和应用的更多见解: 4.2.1 IEC 60601系列； 4.2.2 IEC 80601-2-78； 4.2.3 ISO/DIS 13482； 4.2.4 军事机构制定的产品标准（例如北约标准和美国军事标准）。 4.3 对于每个列出的危险，提供了一个伤害场景示例和可能的伤害示例。 这些示例用于说明与此类危险相关的潜在安全后果。它们并没有全面列出使用外骨骼可能导致的所有急性或慢性损伤。此外，尽管本指南未涉及可能导致物体损坏的危险，但在风险分析过程中也应考虑这些危险。 4.4 本指南不提供将风险管理过程应用于外骨骼的详细指南。然而，生产商应使用结构化方法来识别和监测危险，并在整个外骨骼生命周期内缓解相关风险。有关风险管理的其他指南，请参见以下标准: 4.4.1 ISO 31000； 4.4.2 ISO 14971。 4.5 本指南不取代国际、国家、联邦、州、部落、地方或地区政府的任何既定法律或法规。

1.1 This guide lists typical hazards that should be considered by exoskeleton producers when analyzing and managing potential risks related to exoskeletons. 1.2 Where possible, this guide provides references to agency standards, regulations, or guidelines for assessment of risks related to these hazards and for application of risk reduction measures. 1.3 This guide applies to all exoskeleton types, regardless of the applications of the technology such as consumer, industrial, medical, military, and emergency management services. 1.4 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. 1.6 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 Development of exoskeleton technologies requires careful analysis of potential risks that may be associated with their use. Failure to adequately assess risks may give rise to hazardous situations at many instances of exoskeleton use, for example during completion of human trials, during exoskeleton demonstrations in trade shows, as well as during exoskeleton training, wear, operation, transportation, maintenance, and disposal. 4.2 This guide provides a minimum set of hazards that should be considered by producers when analyzing and mitigating risks related to exoskeletons. This set of hazards should be supplemented with other hazards that may reflect unique safety concerns relevant to the exoskeleton technology and application. The following sources may provide additional insight based on exoskeleton technology and application: 4.2.1 IEC 60601 series; 4.2.2 IEC 80601-2-78; 4.2.3 ISO/DIS 13482; 4.2.4 Product standards established by military agencies (examples are NATO standards and United States Military Standards). 4.3 For each listed hazard, one example of harm scenario and examples of possible harm are provided. These examples are used to illustrate potential safety consequences related to such hazards. They do not reflect a comprehensive list of all possible acute or chronic injuries that may result from exoskeleton use. Additionally, although this guide does not address hazards that may result in damage of objects, these should be considered as well during the risk analysis process. 4.4 This guide does not provide detailed guidance for application of risk management processes to exoskeletons. However, the producer should use a structured approach to identify and monitor hazards, and mitigate related risks throughout the exoskeleton life-cycle. Additional guidance on risk management can be found in the following standards: 4.4.1 ISO 31000; 4.4.2 ISO 14971. 4.5 This guide does not supersede any established laws or regulations of international, national, federal, state, tribal, local, or regional governments.