1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58description of external orthoses and orthotic componentsICS 11.040.40Prosthetics and orthotics Cate
2、gorization and BRITISH STANDARDBS ISO 13404:2007BS ISO 13404:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 September 2007 BSI 2007ISBN 978 0 580 53919 0Amendments issued since publicationAmd. No. Date CommentsCompliance with a Britis
3、h Standard cannot confer immunity from legal obligations. National forewordThis British Standard is the UK implementation of ISO 13404:2007.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.A list of organizations represented on this commi
4、ttee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Reference numberISO 13404:2007(E)INTERNATIONAL STANDARD ISO13404First edition2007-07-01Prosthetics and orthotics
5、 Categorization and description of external orthoses and orthotic components Prothses et orthses Classification et description des orthses externes et des composants dorthses BS ISO 13404:2007ii iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of nationa
6、l standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Internation
7、al organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules
8、 given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at le
9、ast 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13404 was prepared by Technical Committee ISO/TC 16
10、8, Prosthetics and orthotics. BS ISO 13404:2007iv Introduction No internationally accepted method has been available to classify or describe external orthoses and the components from which they are assembled. This situation has created difficulty for practitioners prescribing orthoses, for manufactu
11、rers producing literature describing their products, and for those reporting on prescriptions employed in the treatment of particular patient groups. This International Standard permits the systematic classification and description of both the finished orthosis and the components from which it is as
12、sembled in a manner that clearly explains their principal characteristics. Manufacturers trade names and details of materials and manufacturing processes have been avoided. BS ISO 13404:20071Prosthetics and orthotics Categorization and description of external orthoses and orthotic components 1 Scope
13、 ISO 13404 establishes a means of classifying and describing external orthoses and the components from which they are assembled. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For
14、 undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8549-1, Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses ISO 8549-3, Prosthetics and orthotics Vocabulary Part 3: Terms relating to
15、external orthoses ISO 8551, Prosthetics and orthotics Functional deficiencies Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis 3 Terms and definitions For the purposes of this document, the terms and definitions g
16、iven in ISO 8549-1, ISO 8549-3 and ISO 8551 and the following apply. 3.1 custom fabricated orthosis device that is designed and manufactured to meet the functional requirements of the individual user based on information such as moulds, models, measurements and images 3.2 prefabricated orthosis devi
17、ce that has been designed to meet particular functional requirements and is normally available in a range NOTE The selected orthosis might require adjustment for the individual user. 4 Classification of orthoses 4.1 General description Describe the orthosis by reference to the body segments and join
18、ts which it encompasses using the terminology defined in ISO 8549-3 and shown in Table 1. BS ISO 13404:20072 Table 1 Terminology defined in ISO 8549-3 Device Abbreviation Foot orthosis Ankle-foot orthosis Knee orthosis Knee-ankle-foot orthosis Hip orthosis Hip-knee orthosis Hip-knee-ankle-foot ortho
19、sis Finger orthosis Hand orthosis Wrist-hand orthosis Wrist-hand-finger orthosis Elbow orthosis Elbow-wrist-hand orthosis Shoulder orthosis Shoulder-elbow orthosis Shoulder-elbow-wrist-hand orthosis Sacro-iliac orthosis Lumbo-sacral orthosis Thoraco-lumbo-sacral orthosis Cervical orthosis Cervico-th
20、oracic orthosis Cervico-thoraco-lumbo-sacral orthosis FO AFO KO KAFO HpO HKO HKAFO FO HdO WHO WHFO EO EWHO SO SEO SEWHO SIO LSO TLSO CO CTO CTLSO 4.2 Function 4.2.1 The function of the orthosis may be to manage a deformity: a) to prevent a deformity (i.e. to stop a joint or segment moving into an ab
21、normal alignment); b) to reduce a deformity (i.e. to move a joint or segment to an improved alignment and hold the correction obtained); c) to hold a deformity (i.e. to prevent an irreducible deformity from increasing). Specify the joint(s) and/or segment(s) and the alignment which the orthosis is d
22、esigned to achieve. 4.2.2 The function of the orthosis may be to change the range of motion of a joint(s): a) to limit the range of motion of a joint; b) to increase the range of motion of a joint. Specify the joint(s) and the range(s) of motion which the orthosis is designed to achieve. BS ISO 1340
23、4:200734.2.3 The function of the orthosis may be to change the dimensions of a limb segment(s): a) to add to the length of a segment; b) to improve the shape of a segment. Specify the segment and the magnitude of the length addition and/or the change of shape that the orthosis provides. 4.2.4 The fu
24、nction of the orthosis may be to manage abnormal neuromuscular function: a) to compensate for weak muscle activity; b) to control the effect of muscle hyperactivity. Specify the joint moment(s) which the orthosis is designed to produce. 4.2.5 The function of the orthosis may be to reduce or redistri
25、bute the load on tissue (e.g. to redistribute pressure on the plantar surface of the foot or to reduce the load on a tibial fracture). Specify the tissue loading that the orthosis is designed to reduce or redistribute. 4.3 Type of fabrication The orthosis may be: a) custom fabricated or b) prefabric
26、ated. State the type of fabrication. 5 Classification of orthotic components 5.1 General External orthoses are constructions comprising the following classes of components: a) interface components; b) articulating components; c) structural components; d) cosmetic components. NOTE Some components mig
27、ht belong to more than one class, e.g. moulded plastic shells may serve as interface, articulating and structural components. 5.2 Interface components Interface components of orthoses are those in direct contact with the user. They transmit the forces between the orthosis and the user which result f
28、rom its function and may retain the orthosis in place. BS ISO 13404:20074 Interface components include the following. a) Shells, which encompass body segments (or parts thereof). They are wholly or partially circumferential and may be stiff or flexible and may be opened for entry. Open shells may be
29、 closed by straps. Shells apply forces perpendicular to the surface of the body. A shell may be shaped to be weight bearing: 1) the proximal part of a shell is sometimes referred to as the brim; 2) stiff narrow shells are sometimes referred to as bands; 3) flexible narrow shells are sometimes referr
30、ed to as cuffs. b) Pads, which apply a localized force perpendicular to the surface of a body segment or at a joint and may require straps to achieve this effect. c) Straps, which apply a localized force mainly perpendicular to the surface of a body segment or at a joint. d) Foot orthoses, comprisin
31、g insoles, inserts, pads, arch supports, heel cushions and heel cups which modify the distribution of the forces on the surface of the foot. e) Shoes, which even when not an integral part of orthoses may be essential for their function. State the interface components utilized in the construction of
32、the orthosis. 5.3 Articulating components NOTE Articulating components of orthoses allow or control the motions of anatomical joints. 5.3.1 General Describe the articulating components by including the information given in 5.3.2 to 5.3.6. 5.3.2 Types of articulating component The types of articulati
33、ng component are identified by reference to the anatomical joints whose motions they are intended to allow or control. They include: a) joints for spinal orthoses; b) hip joints; c) knee joints; d) ankle joints; e) foot/toe joints; f) shoulder joints; g) elbow joints; h) wrist joints; i) hand/finger
34、 joints. State the types of articulating component, i.e. the joints, in the orthosis. BS ISO 13404:200755.3.3 Permissible motions The permissible motions of the joints when assembled in the specific orthosis may be: a) flexion/extension; b) dorsiflexion/plantarflexion; c) dorsal/palmar flexion; d) a
35、bduction/adduction; e) internal/external rotation; f) supination/pronation; g) lateral flexion; h) lateral rotation. State for each joint the permissible motions. State if the action of the joint results in simultaneous motion in more than one of these planes. 5.3.4 Form of articulation State for ea
36、ch permissible motion whether it is achieved by: a) movement between parts of the joint and/or b) deformation of a part of the joint. 5.3.5 Axis of rotation Motion is either a) monocentric, in which the axis of rotation is constant for all angles of the joint or b) polycentric, in which the axis of
37、rotation changes with the angle of the joint. State for each permissible motion whether it is monocentric or polycentric. 5.3.6 Controls Joints may incorporate features which control their motion during use. These include mechanisms which: a) lock the joint at a specified angle activation of locking
38、/unlocking may be manual or automatic, in the following combinations: manual lock/manual unlock; BS ISO 13404:20076 automatic lock/manual unlock; automatic lock/automatic unlock; b) limit the range of motion of the joint; c) assist or resist movement of the joint. State the type of control mechanism
39、 for each permissible motion of each joint. State in the case of locks, the method of activation and the angle at which the joint is locked. State in the case of limiting mechanisms, the limits of permitted motion. State in the case of assist or resist mechanisms, the direction of the motion assiste
40、d or resisted. State if any of these features is adjustable. 5.4 Structural components Structural components of orthoses connect the articulating and interface components and maintain the alignment of the orthosis. They include: a) uprights 1) Specify the location of any uprights by reference to i)
41、the anatomical segment(s) situated alongside; ii) their relationship to the segment(s) as: I) medial, II) lateral, III) anterior, IV) posterior; iii) and whether they are length adjustable; NOTE Uprights situated alongside the leg might insert, at their distal end, in a tube mounted in the footwear
42、as part of an articulating component. b) shells (including bands) 1) Specify the location of any shells by reference to the anatomical segments which they encompass. NOTE The structural properties of shells might be enhanced by corrugations or by the use of inserts. BS ISO 13404:200775.5 Cosmetic co
43、mponents Cosmetic components are the means of providing shape, colour and texture to orthoses. They include: a) fillers which compensate for soft tissue deficits; b) covers or sleeves which are applied over the structural and other components to improve appearance. State the cosmetic component(s) us
44、ed in the orthosis. BS ISO 13404:2007BS ISO BSI389 Chiswick High RoadLondonW4 4AL13404:2007BSI British Standards InstitutionBSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorpora
45、ted by Royal Charter.RevisionsBritish Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions.It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone find
46、ing an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400.BSI offers members an individual updating service calle
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