DIN EN ISO 10993-4:2017-12
DIN · 2017-12

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017

Replaced

1Key Takeaways

This standard is part of a series that evaluates the biological aspects of medical devices. Specifically, DIN EN ISO 10993-4 focuses on the selection of tests for assessing interactions between medical devices and blood. It provides guidance to ensure that devices intended to come into contact with blood are evaluated …

2Scope / Description

This standard is part of a series that evaluates the biological aspects of medical devices. Specifically, DIN EN ISO 10993-4 focuses on the selection of tests for assessing interactions between medical devices and blood. It provides guidance to ensure that devices intended to come into contact with blood are evaluated appropriately for potential adverse effects.

3Version History

DIN EN ISO 10993-4:2007 older 2007-06
DIN EN ISO 10993-4:2007-06 older 2007-06-01
DIN EN ISO 10993-4:2009 older 2009-10
DIN EN ISO 10993-4/A2 E:2009-02 Amd E/2009-02 older 2009-02-01
DIN EN ISO 10993-4:2009-10 older 2009-10-01
DIN EN ISO 10993-4 E:2016 Amd E/2016-01 older 2016-02-01
DIN EN ISO 10993-4 E:2016-02 Amd E/2016-02 older 2016-02
DIN EN ISO 10993-4:2017 older 2017-12-01
DIN EN ISO 10993-4/A1 E:2024 Amd E/2024-01 newer 2024-04-01
DIN EN ISO 10993-4/A1:2024-04 Amd /A1/2024-04 newer 2024-04
DIN EN ISO 10993-4:2025-09 newer 2025-09-01

5Citation Network

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6Frequently Asked Questions

What is DIN EN ISO 10993-4:2017-12?
DIN EN ISO 10993-4:2017-12 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017 is an international standard developed by German Institute for Standardization. This standard is part of a series that evaluates the biological aspects of medical devices. Specifically, DIN EN ISO 10993-4 focuses on the selection of tests for assessing interactions between medical devices and blood. It provides guidance to...
What does DIN EN ISO 10993-4:2017-12 cover?
This standard covers: This standard is part of a series that evaluates the biological aspects of medical devices. Specifically, DIN EN ISO 10993-4 focuses on the selection of tests for assessing interactions between medical devices and blood. It provides guidance to ensure that devices intended to come into contact with...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of DIN EN ISO 10993-4:2017-12?
The current published version is DIN EN ISO 10993-4:2017-12, published on 2017-12. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 10993-4:2017-12?
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