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BS EN ISO 21535:2024

BS EN ISO 21535:2024

$167.15

Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

Published By Publication Date Number of Pages
BSI 2024 44
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This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

PDF Catalog

PDF Pages PDF Title
2 undefined
8 Annex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
14 Foreword
16 Introduction
17 1 Scope
2 Normative references
19 3 Terms and definitions
23 4 Intended performance
5 Design attributes
5.1 General
24 5.2 Tolerances and dimensions
5.2.1 Tolerances and dimensions of taper connections
5.2.2 Tolerances on diameters of articulating surfaces, sphericity of articulating surfaces and surface finish of articulating surfaces
25 5.3 Thickness of acetabular components, bipolar heads and dual mobility heads
5.3.1 General
5.3.2 Thickness of UHMWPE in acetabular components, bipolar heads and dual mobility heads
26 5.3.3 Thickness of metal and ceramic acetabular shell and acetabular liner components, bipolar heads, and dual mobility heads
27 6 Materials
7 Design evaluation
7.1 General
28 7.2 Pre-clinical evaluation
7.2.1 General
30 7.2.2 Test methods and performance requirements
36 7.3 Clinical investigation
7.4 Post market surveillance
8 Manufacture
9 Sterilization
37 10 Packaging
11 Information to be supplied by the manufacturer
11.1 General
11.2 Product type and dimensions
11.3 Structural and functional compatibility of components
11.4 Marking
38 11.5 Information for the patient
11.6 Information for the surgeon
11.7 Electronic instructions for use
39 Annex A (normative) Evaluation of the range of relative angular motion of the femoral and acetabular components of a total hip replacement
42 Bibliography

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BS EN ISO 21535:2024
$167.15