DIN EN ISO 10993-4 E:2016-02
DIN · 2016-02
Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood (Draft)
Replaced
1Key Takeaways
DIN EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2015); German and English version prEN ISO 10993-4:2015 This standard specifies the selection of tests for evaluating the interactions of medical devices with blood. It provides guidanc…
2Scope / Description
DIN EN ISO 10993-4
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2015); German and English version prEN ISO 10993-4:2015
This standard specifies the selection of tests for evaluating the interactions of medical devices with blood. It provides guidance for assessing the hemocompatibility of medical devices that come into direct or indirect contact with circulating blood, including in vitro and in vivo testing methods. The standard is applicable to manufacturers and regulatory bodies involved in the biological evaluation of medical devices.
3Version History
5Citation Network
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Cite this standard
2
Referenced herein
Referenced by DIN EN ISO 10993-4 E:2016-02
ISO 10993-1:2009
ISO 10993-2:2006
6Frequently Asked Questions
What is DIN EN ISO 10993-4 E:2016-02?
DIN EN ISO 10993-4 E:2016-02 — Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood (Draft) is an international standard developed by German Institute for Standardization. DIN EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2015); German and English version prEN ISO 10993-4:2015 This standard specifies the selection of tests for...
What does DIN EN ISO 10993-4 E:2016-02 cover?
This standard covers: DIN EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2015); German and English version prEN ISO 10993-4:2015 This standard specifies the selection of tests for evaluating the interactions of medical devices with blood....
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 E:2016-02?
The current published version is DIN EN ISO 10993-4 E:2016-02, published on 2016-02. Always check for amendments or pending revisions.
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