STN EN ISO 21535
| Name: | STN EN ISO 21535 |
| Validity: | Valid |
| Number of pages: | 44 |
| 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 bedrového kĺbu (ISO 21535: 2023) |
| English title | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
| Release Date: | 01. 10. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2937 |
| Level of incorporation: | idt EN ISO 21535:2024, idt ISO 21535:2023 |
| Official Journal | 09/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 21535:2009-09 (85 2937) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |