4851903 0066394 5 L-910-el ISO INTERNATIONAL STANDARD 8827 First edition 1988-10-15 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION MEXKAYHAPOAHAHOPTAHM3ALMROCTAHAAPTM3AUMM Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements générales Reference number ISO 8827: 1988 (E) Copyright International Organization for Standardization Not for Resale d without license from IHS 8827-88 S6E9900 E06T5 ISO 8827 : 1988 (E) Foreword Iso (the International Organization for Standardization) is a worldwide federation of national 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. International organizations, govern- mental 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. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council. They are approved in accordance with IsO procedures requiring at least 75 % approval by the member bodies voting. International Standard ISO 8827 was prepared by Technical Committee ISO/TC 150, Implants for surgery. Users should note that all International Standards undergo revision from time to time and that any reference made herein to any other International Standard implies its latest edition, unless otherwise stated. @ International Organization for Standardization, 1988 Printed in Switzerland Copyright International Organization for Standardization fromIHS Not for Resale 99-2299 96E9900 E06T59 ISO 8827 : 1988 (E) INTERNATIONAL STANDARD Implants for surgery -- Staples with parallel legs for orthopaedic use - General requirements 3 Design 1 Scope and field of application This International Standard covers general requirements and 3.1 Radius of curvature the designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery. The internal radius of curvature of staples made from wire shall be not less than 2 mm or the diameter of the wire, whichever is NOTE -- The annex gives guidance on the selection and use of staples the greater. The curve shall have a smooth contour. and does not form an integral part of this International Standard. 3.2Points Points of staples shall be conical, trocar-shaped, spear-shaped or flattened (i.e tapered in one plane). 2 References 3.3Legs Iso 5832, Implants for surgery -- Metallic materials -- The legs shall be parallel. Part 1: Wrought stainless steel. NOTES 1 Examples of typical forms of staples used in orthopaedic surgery Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. are illustrated in figure 1. Figure 1 shows the designation of dimensions and gives nomenclature; it does not purport to specify design Part 4: Cobalt-chromium-molybdenum casting alloy. requirements and does not otherwise form part of the requirements for staples as laid down in this International Standard. Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. 2 Staples are commonly of circular, oval or modified rectangular cross-section, although other forms may be used. If staples are made from wire, wire 2,5 mm in diameter is commonly used. Greater IsO 6018, Implants for surgery - General requirements for strength may be achieved by using an oval cross-section, generally of marking, packaging and labelling. the order of 4 mm x 2 mm, or by reinforcing the bend area with webs [see figure 1b)]. The legs may be plain, or have barbs or other surface ISo 6892, Metallic materials - Tensile testing. features or treatments. Copyright International Organization for Standardization