🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 21536:2024

BS EN ISO 21536:2024

$167.15

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

Published By Publication Date Number of Pages
BSI 2024 38
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This document specifies requirements for knee-joint replacement implants. Regarding 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 knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of knee replacement implants, but for some specific knee 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
12 Foreword
14 Introduction
15 1 Scope
2 Normative references
16 3 Terms and definitions
20 4 Intended performance
5 Design attributes
5.1 General
21 5.2 Tolerances and dimensions
5.2.1 Tolerances and dimensions of taper connections
22 5.2.2 Surface finish of non-articulating regions of knee joint components
5.2.3 Surface finish of articulating surfaces of knee joint components
5.3 Thickness of knee joint components
5.3.1 General
5.3.2 Thickness of UHMWPE in tibial inserts, monobloc tibial components, mobile-bearing components, patella inserts and monobloc patellar components
23 5.3.3 Thickness of metal and ceramic in femoral components, tibial trays and patellar trays
24 6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.2.1 General
26 7.2.2 Test methods and performance requirements
32 7.3 Clinical investigation
33 7.4 Post market surveillance
8 Manufacture
9 Sterilization
10 Packaging
11 Information to be supplied by the manufacturer
11.1 General
11.2 Product type and dimensions
34 11.3 Constructional and functional compatibility of components
11.4 Marking
11.5 Information for the patient
11.6 Electronic instructions for use
35 Annex A (informative) Evaluation of the range of relative angular motion of components of fully constrained total knee joint replacement implants
36 Bibliography

Related products

BS EN ISO 21536:2024
$167.15