DIN EN ISO 14630:2025-03
Non-active surgical implants - General requirements (ISO 14630:2024); German version EN ISO 14630:2024
| Fecha edición: |
2025-03-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. |
| Keywords: | Biological hazards|CE marking|Checks|Clinical|Construction details|Damage|Data of the manufacturer|Definitions|Design|Evaluations|Fine mechanics|General section|Implants (surgical)|Inactive|Information|Labelling|Marking|Materials|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Packages|Performance|Production|Protection|Residues|Specification (approval)|Sterile|Sterility|Sterilization (hygiene)|Storage|Surgery|Surgical|Surgical implants|Testing|Transport |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 14630:2024 Idéntica ISO 14630:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 14630:2013-03 Reemplaza a DIN EN ISO 14630:2022-10 |
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