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.