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- Title
STANDARDI ZA PROTETIKO IN ORTOTIKO STANDARDS FOR PROSTHETICS AND ORTHOTICS.
- Authors
Mlakar, Maja
- Abstract
The article describes the standards that are related to various activities in the field of prosthetics and orthotics. What all the activities in this field have got in common are prostheses and orthoses, or more generally speaking, medical devices. In 2020, the new legislation of the European Union, represented by the Regulation (EU) 2017/745 on medical devices, will become directly applicable. That document defines the requirements for all participants in the medical devices market. Each participant in this process will have to demonstrate the conformity of their work process on the basis of compliance with the applicable standards. In 2017, the World Health Organisation adopted an important document in this field. In 60 points, the World Health Organisation's Standards for Prosthetics and Orthotics define recommendations, guidelines and requirements in various areas of prosthetics and orthotics.
- Subjects
WORLD Health Organization; MEDICAL equipment; ORTHOPEDIC apparatus; PROSTHETICS; EUROPEAN Union; WORK in process; WORLD health
- Publication
Rehabilitation / Rehabilitacija, 2019, Vol 18, p13
- ISSN
1580-9315
- Publication type
Article