DIN EN ISO 10993-12:2026-02
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021 + Amd 1:2025); German version EN ISO 10993-12:2021 + A1:2025
| Fecha edición: |
2026-02-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: - test sample selection; - selection of representative portions from a medical device; - test sample preparation; - experimental controls; - selection of, and requirements for, reference materials; - preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. |
| Keywords: | Bioassay|Biological|Biological tests|CE marking|Certification|Checks|Conditions|Cytotoxicity|Definitions|Dental equipment|Dental instruments|Evaluations|Extraction|Extracts|Implants (surgical)|Materials|Medical devices|Medical equipment|Medical products|Particles|Patterns|Preparation|Production|Reference materials|References|Samples|Selection|Specification (approval)|Specimen preparation|Standards|Surfaces|Surgical equipment|Surgical implants|Surgical instruments|Temperature|Test samples|Testing |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-12:2021/A1:2025 Idéntica ISO 10993-12:2021/Amd 1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-12:2021-08 Reemplaza a DIN EN ISO 10993-12/A1:2024-07 |
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