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ISO/DIS 10993-11.2

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

General information

40.20     May 13, 2026

ISO

ISO/TC 194

International Standard

11.100.20  

Buying

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Scope

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 10993-11:2017

NOW

PROJECT
ISO/DIS 10993-11.2
40.20 DIS ballot initiated: 12 weeks
May 13, 2026

National adoptions

naSRPS EN ISO 10993-11:2023  
ISS

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026)

40.20   DIS ballot initiated: 12 weeks

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