STN EN ISO 21535
| Označenie: | STN EN ISO 21535 |
| Platnosť: | Platná |
| Počet strán: | 44 |
| Jazyk: |
EN
|
| Listinná verzia: | 18,90€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
| Slovenský názov: | Neaktívne chirurgické implantáty. Implantáty kĺbov. Špecifické požiadavky na implantáty bedrového kĺbu (ISO 21535: 2023) |
| Anglický názov: | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
| Dátum vydania: | 01. 10. 2024 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 2937 |
| Úroveň zapracovania: | idt EN ISO 21535:2024, idt ISO 21535:2023 |
| Vestník: | 09/24 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 21535:2009-09 (85 2937) |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |