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naSRPS EN ISO 10993-11:2023

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

General information

40.60     May 30, 2025

ISS

Z076

European Norm

11.100.20  

English  

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 10993-11:2018

NOW

PROJECT
naSRPS EN ISO 10993-11:2023
40.60 Close of voting
May 30, 2025

Related project

Adopted from prEN ISO 10993-11 IDENTICAL

Adopted from ISO/DIS 10993-11 IDENTICAL