DIN EN ISO 10993-6:2024-06
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024 / Note: Date of issue 2024-05-24
| Fecha edición: |
2026-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of materials intended for use in medical devices. In order to evaluate local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, this document is applicable when required. This document applies to medical device/materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable/degradable or non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biocompatibility effects. |
| Keywords: | Bioassay|Biocompatibility|Biological|Biological analysis and testing|Biological hazards|Biological tests|Ceramics|Compatibility|Definitions|Dental equipment|Dental materials|Dentistry|Determination|Effect|Evaluations|Experimental animals|Fabrics|Fine mechanics|Histology|Implantation test|Implants (surgical)|Macroscopic|Materials|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Methods|Muscles|Observation|Polymers|Preparation (medical)|Principle|Production|Reaction|Samples|Scope|Solids|Surgery|Surgical equipment|Surgical implants|Taking-out|Test duration|Test pieces|Testing |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Reemplazo Normas |
Es reemplazada por DIN EN ISO 10993-6:2026-08 |
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