Promotion of Standardization (Transfer Assistance (Non-Restraint Type),
Mobility Support (Indoor and Outdoor), Bathing Assistance, and Toileting Assistance)
I. Research and Development Objectives and Content
Our goal is to propose standards for robotic care devices in each of these fields—transfer assistance (non-worn type), mobility support (outdoors), mobility support (indoors), bathing assistance, and toileting assistance—to the International Organization for Standardization (ISO), an international standards body.
In addition to the discussions we have held over the past four years, we will actively incorporate the findings from our research on safety, effectiveness, and performance conducted through the Standards Consortium into the development of draft standards.
II. Implementation Details
1. Summary of Research Findings
To develop draft standards, we have established a standardization committee composed of experts, as well as subcommittees for each key area, to advance our deliberations. Since the robotic care devices currently under development are positioned as products that incorporate robotic functions into existing assistive devices, our standardization efforts are focused primarily on safety considerations for the robotic adaptation of these assistive devices.
2. Results
As part of the Robot Care Equipment Development and Promotion Project, the Japan Association of Assistive Devices and Living Support Equipment (hereinafter referred to as “JASPA”) was commissioned to develop international standards in five key areas—mobility support (both indoor and outdoor), mobility assistance (non-wearable),toilet assistance, and bathing assistance. The goal was to complete the preparation of a draft proposal to be submitted to ISO Technical Committee 173 (TC173), which oversees assistive devices, by the end of fiscal year 2017.
In fiscal year 2013, we began collecting literature and conducting surveys on domestic and international initiatives, creating a data file that serves as an information library, which we continue to update. Starting in fiscal year 2014, we discussed requirements for safety—the cornerstone of standardization—in subcommittees for each priority area, and each subcommittee drafted preliminary standardization proposals to flesh out and refine the content.To conduct these deliberations efficiently, a new Subcommittee on Common General Rules was established in fiscal year 2016 to consolidate and examine safety requirements common to all priority areas. We sought to incorporate insights accumulated by other working groups within the Standards Council, such as the Safety WG, into the standardization process, thereby advancing deliberations in each subcommittee efficiently.
We determined that it would be most reasonable to propose the standardization of devices that extend existing assistive devices and incorporate robotic technology for control to TC 173, which covers assistive devices, and therefore recommended that ISO proceed with the review of robotic versions of existing assistive devices possessing the basic functions of robotic care equipment in each priority area.In the process, coinciding with the revision of the European Medical Devices Directive (2017), work on revising existing ISO standards for welfare equipment began simultaneously. We decided to propose robotic care equipment incorporating robotic technology as an additional clause and compiled and submitted a draft in fiscal year 2017.Non-wearable transfer assistance devices share the common feature with bathing assistance devices in that their primary performance is based on lifting functions. We submitted a revision proposal to add a robotic device clause to WG13, which is considering the revision of the lifting equipment standard, and plan to propose a unified robotic device clause for indoor and outdoor mobility assistance robots under ISO 11199 “Walking Aids.”Regarding toileting assistance devices, we are proceeding with preparations by proposing the addition of a robotics clause during the revision of ISO 17966 “Personal Hygiene Equipment.”We have also submitted a proposal to incorporate general common provisions for robotic care devices into WG12, which was newly established to develop general requirements for welfare equipment, and have successfully submitted an international standardization proposal as part of our five-year standardization project. Since the rule requires that a proposal be finalized as an ISO standard within 36 months of being taken up by ISO, our challenge moving forward is to follow up on the proposal to ensure it becomes an ISO standard.
