STN EN ISO 14630
| Name: | STN EN ISO 14630 |
| 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. Všeobecné požiadavky (ISO 14630: 2024) |
| English title | Non-active surgical implants - General requirements (ISO 14630:2024) |
| Release Date: | 01. 04. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2905 |
| Level of incorporation: | idt EN ISO 14630:2024, idt ISO 14630:2024 |
| Official Journal | 03/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 14630:2013-04 (85 2905) |
| Note in Official Journal: | |
| Subject of the standard: | 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 ... |
| Preview: | Náhľad normy (PDF) |