STN EN ISO 14630
| Označenie: | STN EN ISO 14630 |
| Platnosť: | Platná |
| Počet strán: | 40 |
| 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. Všeobecné požiadavky (ISO 14630: 2024) |
| Anglický názov: | Non-active surgical implants - General requirements (ISO 14630:2024) |
| Dátum vydania: | 01. 04. 2025 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 2905 |
| Úroveň zapracovania: | idt EN ISO 14630:2024, idt ISO 14630:2024 |
| Vestník: | 03/25 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 14630:2013-04 (85 2905) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its ... |
| Náhľad normy: | Náhľad normy (PDF) |