Guided search - Regulations
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Orthoses are externally applied devices used to modify the structural and functional characteristics of the neuro-muscular and skeletal systems; prostheses are externally applied devices used to replace, wholly or in part, an absent or deficient body segment.; Included are, e.g., body-powered and externally powered external orthoses, prostheses, cosmetic prostheses and orthopaedic footwear.; Excluded are endo-prostheses, which are not part of this International Standard.
Orthoses designed to modify the structural and functional characteristics of the neuro-muscular and the skeletal systems of the lower limb; the devices may be custom-fabricated, i.e. designed to meet the functional requirements of the individual user, or prefabricated, i.e. designed to meet particular functional requirements; the prefabricated devices are adjustable, i.e. need adjustment for the individual user, or ready to use, i.e. need no adjustment for the individual user
Orthoses that encompass the whole or part of the foot; Included are, e.g., insoles and shoe inserts, pads, arch supports, heel cushions and heel cups and orthopaedic inlays.
Orthoses that encompass the ankle joint and the whole or part of the foot
Orthoses that encompass the knee and ankle joints and the foot
Orthoses that encompass the hip, knee and ankle joints and the foot
Orthoses that encompass the lumbar regions of the trunk, the hip, knee and ankle joints and the foot, with or without the thoracal part of the spine
Orthotic joints used as components of lower limb orthoses to allow or control motion of the foot and toe joints
Orthotic joints used as components of lower limb orthoses to allow or control motion of the ankle joint
Orthotic joints used as components of lower limb orthoses to allow or control motion of the knee joint
Orthotic joints used as components of lower limb orthoses to allow or control motion of the hip joint
Interface components in direct contact with the user; they transmit the forces between the orthosis and the user that result from its function and may retain the orthosis in place. Included are, e.g. shells, pads, straps, foot orthoses, shoes.
Structural components in direct contact the articulating and interface components and maintain the alignment of the orthosis. Included are, e.g. uprights, shells.
Cosmetic components that provide shape, colour and texture to orthoses. Included are, e.g. fillers, covers, sleeves.
