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DIN EN ISO 10993-5/A11:2025-05

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009/A11:2025

Edition date: 2025-05-01
In Force
Available languages: English, German
Summary: This document describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. This European amendment is intended to add the Annex ZA to the Medical Device Regulation. It is not an amendment to the ISO text.
Keywords: Bioassay|Biological analysis and testing|CE marking|Culture media|Cytotoxicity|Dental equipment|Dental instruments|Implants (surgical)|In vitro|In-vitro diagnostic|Medical devices|Medical equipment|Medical products|Medical sciences|Surgical equipment|Surgical implants|Test methods|Testing
ICS: 11.100.20-Biological evaluation of medical devices
CTN:

Modificaciones Normas

Modifica a DIN EN ISO 10993-5:2009-10

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