1、BRITISH STANDARD BS 2574-2: 1994 Lower limb orthoses Part 2: Specification for hip, knee and ankle joints for lower limb orthoses UDC 615.477.22BS2574-2:1994 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof
2、the Standards Boardand comes into effect on 15December 1994 BSI 07-1999 First published as BS 2574, March1955 Second edition as BS 2574-2, February 1985 Third edition December 1994 The following BSI references relate to the work on this standard: Committee reference HCC/9 Draft for comment 93/507765
3、 DC ISBN 0 580 23540 8 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health and Environment Sector Board to Technical Committee HCC/9, upon which the following bodies were represented: British Institute of Surgical Technologists Britis
4、h Limbless Ex-service Mens Association British Medical Association British Orthopaedic Association British Plastics Federation British Surgical Trades Association Chartered Society of Physiotherapy College of Occupational Therapists Consumer Policy Committee of BSI Department of Health Disablement S
5、ervices Authority International Society for Prosthetics and Orthotics (United Kingdom National Society) National Centre for Training and Education in Prosthetics and Orthotics Opportunities for the Disabled Orthotic and Prosthetic Training and Education Council (OPTEC) Royal College of Nursing and N
6、ational Council for Nurses of the UnitedKingdom Royal College of Surgeons of Edinburgh Royal College of Surgeons of England SATRA Footwear Technology Centre Scottish Home and Health Department Scottish Office Society of Chiropodists and Pediatrists Surgical Appliance Manufacturers Association Amendm
7、ents issued since publication Amd. No. Date CommentsBS2574-2:1994 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 References 1 3 Definitions 1 4 Information to be supplied by the purchaser 1 5 Investment castings 2 6 Workmanship 2 7 Assembly of the joint
8、 and side members 2 8 Packaging, marking and instructions 2 Annex A (informative) Recommendations regarding information to be exchanged between the supplier(s) of materials and castings, and the joint manufacturer 4 Table A.1 Information to be supplied to the foundry by the joint manufacturer 4 List
9、 of references Inside back coverBS2574-2:1994 ii BSI 07-1999 Foreword This Part of BS 2574 has been prepared under the direction of the Health and Environment Sector Board. It supersedes BS 2574-2:1985 and BS2931:1957, which are withdrawn. The other Parts of BS2574 are currently as follows: Part 1:
10、Guide to the design and manufacture of lower limb orthoses (excluding foot orthoses); Part 3: Method for the determination of mechanical properties of metal knee joints and side member assemblies. BS 2574 was first published in1955 as Specification for component parts of temporary unjointed orthopae
11、dic calipers. Subsequently, separate British Standards were issued dealing with knee joints, ankle joints, leather components and aluminium alloy orthoses. The first revision of BS2574 was published in1977 as BS2574-1, which incorporated the relevant requirements of those separate standards and spec
12、ified basic design requirements, including those for steel and aluminium alloy side members for unjointed knee-ankle-foot orthoses. Part 1 was withdrawn in1984 until an extensive revision of that standard could be published in1991. The first edition of Part 2 of BS2574, which was published in1985, s
13、uperseded both BS2932:1957 and BS3563:1962. It differed from those standards in that it specified neither a particular design of joint nor the materials to be used but established general requirements within which the manufacturer of the joint could exercise experience, expertise and innovation with
14、 respect to design and execution. The1985 edition also introduced the modern terminology for orthopaedic appliances in which the type of orthosis is described by the anatomical joints that it encompasses, the description being abbreviated where necessary by the formulation of acronyms from the initi
15、al letters of the names of the joints in the English language. The standardization of this terminology has now been established by the International Organization for Standardization (ISO) and is published inBS7313. The Technical Committee responsible for the preparation ofBS2574-2 has found it possi
16、ble neither to specify the amount of medio-lateral free play in knee joints nor to devise a method of test to measure it with sufficient accuracy and precision. The condition in which the joint assembly is to be supplied (including the permissible amount of free movement) is to be specified by the p
17、urchaser (seeclause4). Information to be exchanged between the supplier(s) of materials and castings, and the joint manufacturer is detailed inAnnex A. Type testing of knee joint assemblies is specified, but values for test results are not specified. This is to leave the orthotist free to order join
18、ts with the specific properties required for individual patients. Testing of other joint assemblies is not specified, as a standard giving the required test methods has yet to be developed. This revision of BS2574-2 also constitutes a revision of BS2931 Specification for steel ankle joints for steel
19、 orthopaedic appliances which was first published in1957. It essentially up-dates the performance requirements of both standards, and also extends the application to hip joints. This Part of BS2574 is aligned where possible with the recently published Parts1 and3 of the standard. Product certificati
20、on. Users of this British Standard are advised to consider the desireability of third party certification of product conformity with this British Standard based on testing and continuing product surveillance which may be coupled with assessment of a suppliers quality systems against the appropriate
21、standard in the BSENISO9000 series.BS2574-2:1994 BSI 07-1999 iii Enquiries as to the availability of third party certification schemes are forwarded by BSI to the Association of British Certification Bodies. If a third party certification scheme does not already exist, users should consider approach
22、ing an appropriate body from the list of Association members. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity fro
23、m legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages1to 4, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment
24、table on the inside front cover.iv blankBS2574-2:1994 BSI 07-1999 1 1 Scope This Part of BS 2574 specifies performance requirements for hip, knee and ankle joints that are to be incorporated in the side members to be used in lower limb orthoses. This Part of BS 2574 is not applicable to joints for u
25、se in the immediate treatment of trauma cases. NOTEGuidance on the design of orthotic joints is given in BS2574-1:1991. 2 References 2.1 Normative references This Part of BS 2574 incorporates, by dated or undated reference, provisions from other publications. These normative references are made at t
26、he appropriate places in the text and the cited publications are listed on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to or revisions of the cited publication apply to this Part of BS2574 only when incorporated in the reference by amendment
27、 or revision. For undated references, the latest edition of the cited publication applies, together with any amendments. 2.2 Informative references This Part of BS 2574 refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of t
28、his Part of BS2574 are listed on the inside back cover, but reference should be made to the latest editions. 3 Definitions For the purposes of this Part of BS2574 the definitions given in BS2574-1:1991, BS2574-3:1990, BS6324-1:1983, BS6324-2:1983, BS6324-3:1983, BS6324-4:1983, BS7313-1.1:1990 and BS
29、7313-1.3:1990 apply, together with the following. 3.1 hip joint mechanical joint for incorporation in an orthosis in order to permit the required range of movement at the anatomical hip joint 3.2 knee joint mechanical joint for incorporation in the side member of an orthosis that encompasses the kne
30、e in order to permit flexion of the anatomical knee joint in the principal plane of movement (See also2.1 of BS2574-3:1990.) 3.3 ankle joint mechanical joint for incorporation in the side member of an orthosis that encompasses the ankle in order to permit the required range of movement in the princi
31、pal plane of flexion of the anatomical ankle joint 3.4 lock mechanism mechanism that prevents rotation of a mechanical joint 3.5 casting batch castings of similar dimensions produced from the same melt and, if heat treated, heat treated simultaneously 3.6 joint assembly mechanical joint either with
32、integral side members or with side members attached 3.7 side member medial or lateral component of a joint assembly, of either one-piece or composite construction and including side pieces, end pieces or adjustment devices 3.8 stop system in an orthosis designed to prevent an undesired movement of a
33、n anatomical joint 4 Information to be supplied by the purchaser The following information to be supplied by the purchaser shall be fully documented: a) if certificates relating to any castings used in the manufacture of the joint or joint assembly are required (seeclause5); b) in the case of joint
34、assemblies with a lock mechanism, the condition in which the joint assembly is to be supplied (see6.4).BS2574-2:1994 2 BSI 07-1999 5 Investment castings Investment castings, if used, shall be of alloy type CLA as specified in BS3146-1:1974 or of alloy type ANC as specified in BS3146-2:1975. The cast
35、ings shall conform to the requirements relevant to the particular type of casting as given in BS3146-1:1974 or in BS3146-2:1975, as applicable. If the purchaser requires certificates for any castings used in the manufacture of the joint or joint assembly, this shall be stated at the time of enquiry
36、and/or order see clause4 a). NOTESeeAnnex A for information that should be exchanged between the foundry and the joint manufacturer. 6 Workmanship 6.1 Mechanical type testing of metal knee joint and side member assemblies shall be carried out in accordance with BS2574-3:1990. Test results shall be r
37、ecorded as specified in clause7 of BS2574-3:1990, and shall be made available to the purchaser upon justified request. NOTESome ankle joints and hip joints can be type tested using modified procedures based on those described in BS2574-3:1990. However, it may be necessary either to use extension pie
38、ces if the side members are too short for the apparatus or, in the case of ankle joints, to manufacture special joints for testing in which the side members are longer than normal. 6.2 Where moving parts are in contact, the contacting surfaces shall have a surface roughness R a , as measured by one
39、of the methods described in BS1134-1:1988, not exceeding1.64m for male surfaces and not exceeding3.24m for female surfaces. 6.3 Surfaces, other than the contacting surfaces of the joint and lock mechanism, shall have a surface roughness R ano greater than1.64m when measured by one of the methods des
40、cribed in BS1134-1:1988. NOTESliding surfaces in contact should be of materials chosen for their resistance to wear. Surface hardening or plating with a thin metallic film can also improve wear and friction characteristics. 6.4 If a lock mechanism is fitted to the joint assembly, the joint assembly
41、shall be supplied in one of the following conditions, as specified by the purchaser at the time of enquiry and/or order seeclause4 b). a) The joint assembly without any adjustment of the lock mechanism shall not permit unwanted free movement when the lock mechanism is fully engaged (see note). The f
42、it between the parts of the lock mechanism shall be such that there is no movement in the lock mechanism when it is fully engaged. b) The joint assembly shall not permit unwanted free movement when the lock mechanism is fully engaged (see note), but the lock mechanism shall require adjustment to ach
43、ieve this condition. NOTEUnwanted free movement in the joint assembly should be no more than that which is just perceptible upon manipulation. c) The joint assembly shall have a limited, but fixed, range of free movement with the lock mechanism fully engaged. d) The joint assembly shall have a limit
44、ed range of free movement but this range of movement shall be adjustable. Positive means shall be provided for securing the stop in the desired position. The supplier shall provide details of the methods of adjustment for the joint assemblies referred to in itemsb) andd). (See also8.3 a).) 6.5 Joint
45、 assemblies without locks shall be supplied in such a condition that no adjustment of any part of the joint is required. 7 Assembly of the joint and side members 7.1 General There shall be no exposed sharp edges on component parts. 7.2 Joint and side members If the joint and side members are assembl
46、ed from separate components, e.g. by means of rivets or screws, there shall be no free movement between the side members and the joint in any plane when the side members are secured to the joint in accordance with the manufacturers instructions see7.3 b). 7.3 Pivot pins If the joint includes any piv
47、ot pins, the manufacturer shall provide either: a) means to enable each pin to be secured in position after final assembly; or b) instructions on how to secure each pin in position after final assembly if means for securing the pin(s) are not provided see8.3 c). 8 Packaging, marking and instructions
48、 8.1 Packaging Each joint shall be supplied in a package. NOTEJoints of the same type may be packaged together.BS2574-2:1994 BSI 07-1999 3 8.2 Marking Each package shall be marked with, or shall contain literature which gives, at least the following information: a) name and address of the manufactur
49、er and, if appropriate, the manufacturers trademark; b) catalogue number or other identifying reference to the contents; c) unique identification by which the manufacturing details of the product can be traced (see4.8 of BSEN 46001:1994); d) identification of side member material and its heat treatment condition; e) advice that literature, giving further details of the joint assembly and instructions for its use, is available from the manufacturer (see6.4); f) for knee joint assemblies, advice that results of mechanical type tests on the joint assemblies are
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