Research on Safety and Quality Regulatory Policy for Assistive Products |
Kim, Hye-Won
(Department of Public Rehabilitation Service, National Rehabilitation Center)
Kim, Dong-A (Department of Public Rehabilitation Service, National Rehabilitation Center) Seo, Won-San (Department of Public Rehabilitation Service, National Rehabilitation Center) Kim, Jang-Hwan (Department of Biomedical Engineering & Welfare Technology, Hanseo University) Ko, Myeong Han (Department of Rehabilitation Science, Graduate School, Hanseo University) Son, Byung-Chang (Department of Rehabilitation Technology, Nazarene University) Yi, JinBok (Department of Biomedical Engineering & Welfare Technology, Hanseo University) |
1 | Article 3 of the Act on the Support for Assistive products for Persons with Disabilities, No. 13662, 2015. |
2 | JB Yi, J. H. Kim, J. K. Lee, B. C. Son, Legal Improvement & Complement for Assistive Products Safety Control System Buildup, National Rehabilitation Center, 2017. |
3 | M. Gagnon-Roy, A. Bourget, S. Stocco, A. L. Courchesne, N. Kuhne, et al, Assistive Technology Addressing Safety Issues in Dementia: A Scoping Review, The American Journal of Occupational Therapy, Vol. 71, Iss. 5, pp. 1-10, 2017. DOI: https://dx.doi.org/10.5014/ajot.2017.025817 |
4 | M. Claudine, T. Anthea, The Acceptability of Assistive Technology to Older People, Ageing and Society, Vol. 25, Iss. 1, pp. 91-110, 2005. DOI: https://dx.doi.org/10.1017/S0144686X0400248X DOI |
5 | Medical Devices Act, No. 15486, 2018. |
6 | Article 10 of the Act on the Support for Assistive products for Persons with Disabilities, No. 13662, 2015. |
7 | Attached Table 4 of the Enforcement Rules of the Electrical Appliances and Consumer Products Safety Control Act, No. 303, 2018. |
8 | Attached Table 6 of the Enforcement Rules of the Electrical Appliances and Consumer Products Safety Control Act, No. 303, 2018. |
9 | Article 72 of the Act on Welfare of Persons with Disabilities, No. 15270, 2017. |
10 | Paragraph 2, Article 69 of the Act on Welfare of Persons with Disabilities, No. 15270, 2017. |
11 | Subparagraph 1, Paragraph 2, Article 26 of the Enforcement Rules of the National Health Insurance Act, No. 594, 2018. |
12 | A. Nilsson, K. S. Vreede, V. Haglund, H. Kawamoto, Y. Sankai, J. Borg, Gait training early after stroke with a new exoskeleton . the hybrid assistive limb: a study of safety and feasibility, Journal of NeuroEngineering and Rehabilitation, 11:92, 2014. DOI: https://dx.doi.org/10.1186/1743-0003-11-92 DOI |
13 | Subparagraph 1, Paragraph 4, Article 25 of the Medical Care Assistance Act, No. 586, 2018. |
14 | Attached Table 2 of the Public Notice on Designation of Assistive Products, No. 2016-15, 2016. |
15 | J. B. Kang, J. H. Woo, J. Y. Kong, Y. H. Lee, T. Y. Kim, A Study on Support and Vitalizing of the Assistive Devices, pp. 121-122, Korea Disabled people's Development Institute, 2016. ISBN 978-89-6921-210-1(93300) |
16 | A. Souza, J. L. Pearlman, R. Cooper, A. Kelleher, B. Gebrosky, et al, Evaluation of scooters using ANSI/RESNA standards, Journal of Rehabilitation Research and Development, Vol. 50, Iss. 7, pp. 1017-1034, 2013. DOI: https://dx.doi.org/10.1682/JRRD.2011.03.0054 DOI |
17 | National Rehabilitation Center, Report of Assistive Products Safety Control Project, Ministry of Health and Welfare, 2011. |
18 | M. S. Moon, K. H. Kim, J. C. Ryu, S. M. Lee, Y. H. Lee, G. M. Lee, B. S. Song, Y. C. Kim, M. H. Kim, S. M. Kim, Research for Assistive Technology Industry Vitalizing & Assistive Products Safety Control, p. 285, Korea Workers' Compensation & Welfare Service Korea Orthopedics & Rehabilitation Engineering Center, 2008. |
19 | Yamada Y, Kurachi K, Standardization of Care and Assistive Products Involving Robot Technology, Studies In Health Technology And Informatics, Vol. 242, pp. 535-541, 2017. |