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EVS-EN ISO 10993-5:2009/A11:2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

General information

Valid from 15.05.2025
Base Documents
EN ISO 10993-5:2009/A11:2025
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
02.06.2025
Main + amendment
Amendment to EN ISO 10993-5:2009

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Amendment

EVS-EN ISO 10993-23:2021/A1:2025

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)
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Amendment

EVS-EN ISO 14155:2020/A11:2025

Clinical investigation of medical devices for human subjects - Good clinical practice
Withdrawn from 04.05.2026
Amendment

EVS-EN ISO 10993-12:2021/A1:2025

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Valid from 01.10.2025
Main

EVS-EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
Newest version Valid from 15.01.2026