Current status of standardization of prosthesis and orthosis testing methods

Every year, a large number of people, both domestically and internationally, begin to use assistive devices due to disabilities caused by accidents, and an even greater number of elderly people begin to need assistive devices due to aging. Assistive products for the elderly or disabled have a high probability of causing safety accidents for users with reduced musculoskeletal functions, and securing the reliability and safety of the products is very important, and standardization of testing methods for this is urgently required. However, in the case of assistive devices, they are often custom-made for each patient rather than mass-produced, so standardization of test methods is being developed very slowly. In this paper, we report on the standardization status of assistive devices, especially upper and lower limb prosthesis test methods. In the case of the upper limb prosthesis, there are seven unique Korean standards, five standards established by ISO, and one standard that is both an ISO standard and a Korean standard. The seven standards developed independently in Korea need to be promoted as ISO standards in the future. In the case of the lower limb prosthesis, seven test method standards out of twelve ISO standards,, excluding 5 standards corresponding to medical and theoretical explanations, have been established as harmonized Korean standards. The development of testing method standards in the field of assistive products will lead the advancement of the domestic assistive product industry and contribute to improving the quality of life of the disabled and the elderly.

Authors

Publication Details

Journal
Society for Standards Certification and Safety
Published
2025-03-31
DOI
https://doi.org/10.34139/jscs.2025.15.1.30
Primary Topic
Orthopaedic implants and arthroplasty
Type
article
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article

Current status of standardization of prosthesis and orthosis testing methods

Inhyuk Moon, Sangsoo Park, lee suk-min
Society for Standards Certification and Safety
Orthopaedic implants and arthroplasty
article

Current status of standardization of prosthesis and orthosis testing methods

Inhyuk Moon, Sangsoo Park, lee suk-min
article en

Abstract

Every year, a large number of people, both domestically and internationally, begin to use assistive devices due to disabilities caused by accidents, and an even greater number of elderly people begin to need assistive devices due to aging. Assistive products for the elderly or disabled have a high probability of causing safety accidents for users with reduced musculoskeletal functions, and securing the reliability and safety of the products is very important, and standardization of testing methods for this is urgently required. However, in the case of assistive devices, they are often custom-made for each patient rather than mass-produced, so standardization of test methods is being developed very slowly. In this paper, we report on the standardization status of assistive devices, especially upper and lower limb prosthesis test methods. In the case of the upper limb prosthesis, there are seven unique Korean standards, five standards established by ISO, and one standard that is both an ISO standard and a Korean standard. The seven standards developed independently in Korea need to be promoted as ISO standards in the future. In the case of the lower limb prosthesis, seven test method standards out of twelve ISO standards,, excluding 5 standards corresponding to medical and theoretical explanations, have been established as harmonized Korean standards. The development of testing method standards in the field of assistive products will lead the advancement of the domestic assistive product industry and contribute to improving the quality of life of the disabled and the elderly.

Society for Standards Certification and SafetyVol. 15(1)
Openalex Percentile: Top 89%
Orthopaedic implants and arthroplasty
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