Standard Guide for Application of Risk Management to Exoskeletons

Importancia y uso:

4.1 Some level of risk of harm to health is inherent in all products or systems, including exoskeletons. However, safety (defined as “freedom from risk that is not tolerable”) can be pursued by risk management techniques that entail systematic application of knowledge, experience, insight, and judgment to identify, estimate, evaluate and, when necessary, reduce risks. In addition, safety requirements can be articulated to support risk management and accelerate decisions and verifications pertaining to product safety.

4.2 A number of standards exist that provide guidelines to risk management and those that express safety requirements for specific products. However, these are not easily applicable to exoskeletons or can be applied only to subclasses of exoskeletons. For this reason, this guide seeks to formulate guidelines applicable specifically to exoskeletons. For example, ISO 31000 provides guidelines to risk management applicable to any type of risk, to any industry or sector, and to any activity of an organization. As such, its scope is too broad to be effectively applied to exoskeletons. On the other hand, certain standards provide guidelines and requirements that apply to product classes that may include certain types of exoskeletons. For example:

4.2.1 ISO 14971 provides guidelines for application of risk management to medical devices, as such it may be applicable to exoskeletons that are intended to be used as a medical device;

4.2.2 IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment and may apply to exoskeletons that are intended for use as medical electrical equipment;

4.2.3 IEC 80601-2-78 specifies requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation, or alleviation, and may therefore apply to exoskeletons that fit the definition of medical robots;

4.2.4 ISO 10377 provides guidelines to application of risk management to consumer products, and may therefore be applicable to exoskeletons that are intended for personal use;

4.2.5 ISO 13482 provides safety requirements that may be applicable to exoskeletons intended to be used as personal care robots;

4.2.6 ISO 12100 specifies principles and a methodology for achieving safety in the design of machinery and may therefore apply to exoskeleton designs that are constructed as machines.

4.3 The scopes of these standards cover large product groups that may happen to encompass certain models of exoskeletons. However, they do not focus specifically on exoskeletons and may therefore oversee particular concerns generated by exoskeletons. Furthermore, such product-specific standards can be simply overlooked by producers of exoskeletons that are not intended to be used as specified in the respective standard scopes, and for which today there are no standards that articulate risk management guidelines or safety requirements.

4.4 Risk management guidelines given in this guide specifically address concerns related to exoskeletons. This guide does not seek to replace product-specific standards, such as those referenced in the previous paragraph, but to compliment them.

4.5 This guide is addressed to producers and focuses specifically on management of risks that may result in harm to health. However, the notions and guidelines provided here can be used to manage other types of risks, such as damage to property.

4.6 This guide does not specify safety requirements for exoskeletons. These are being established and are expected to be published in the near future.

Subcomité:

F48.02

Volúmen:

15.13

Palabras clave:

exoskeleton; harm; hazard; risk; risk assessment; risk estimation; risk evaluation; risk management; safety;