STN EN ISO 21536
| Name: | STN EN ISO 21536 |
| Validity: | Valid |
| Number of pages: | 40 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Neaktívne chirurgické implantáty. Implantáty kĺbov. Špecifické požiadavky na implantáty kolenného kĺbu (ISO 21536: 2023) |
| English title | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023) |
| Release Date: | 01. 10. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2931 |
| Level of incorporation: | idt EN ISO 21536:2024, idt ISO 21536:2023 |
| Official Journal | 09/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 21536:2009-09 (85 2931) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |