NS-EN ISO 21536:2024
Current
The latest, up-to-date edition.
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
Hardcopy
English
06-08-2024
Important note : Users cannot be edited or removed once added to your Multi user PDF.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.
| Committee |
CEN/TC 285
|
| DocumentType |
Test Method
|
| Pages |
0
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 21536:2024 | Identical |
| ISO 21536:2023 | Identical |
| ISO 5834-3:2019 | Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods |
| ASTM F 2003 : 2002 : R2022 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air |
| ISO 13179-1:2021 | Implants for surgery Coatings on metallic surgical implants Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| ASTM F 1800 : 2019 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 561 : 2019 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
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