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Drejtoria e Përgjithshme e Standardizimit

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ISO/DIS 10993-11

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

General information

Current stage: 40.60 Effective date: Jun 21, 2025

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

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

IN_DEVELOPMENT
ISO/DIS 10993-11
40.60 Close of voting
Jun 21, 2025