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SRPS EN ISO 10993-4:2018/A1:2025

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)

May 30, 2025

General information

60.60     May 30, 2025

ISS

Z076

European Norm

11.100.20  

English  

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Scope

Changes are in 3.4; 5.2.2; 5.2.3; 6.1.4;6.1.6. For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA which
are integral part of this document.

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

Directive 2017/745

Life cycle

NOW

PUBLISHED
SRPS EN ISO 10993-4:2018/A1:2025
60.60 Standard published
May 30, 2025

REVISED BY

PROJECT
prSRPS EN ISO 10993-4:2024

Related project

Adopted from EN ISO 10993-4:2017/A1:2025 IDENTICAL

Adopted from ISO 10993-4:2017/Amd 1:2025 IDENTICAL