DIN EN ISO 10993-4 E:2016
DIN · 2016-02-01
Draft Document - 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
Replaced
1Key Takeaways
This standard provides guidance on the selection of tests to evaluate medical devices that interact with blood. It is part of a series aimed at ensuring the safety and biocompatibility of medical products through comprehensive biological evaluation. The document outlines specific considerations for assessing hemocompat…
2Scope / Description
This standard provides guidance on the selection of tests to evaluate medical devices that interact with blood. It is part of a series aimed at ensuring the safety and biocompatibility of medical products through comprehensive biological evaluation. The document outlines specific considerations for assessing hemocompatibility, including cytotoxicity testing, thrombogenicity assessment, and in vivo testing methods. These guidelines are designed to assist manufacturers in meeting regulatory requirements and ensuring that their devices pose minimal risk when used by patients.
3Version History
5Citation Network
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6Frequently Asked Questions
What is DIN EN ISO 10993-4 E:2016?
DIN EN ISO 10993-4 E:2016 — Draft Document - 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 is an international standard developed by German Institute for Standardization. This standard provides guidance on the selection of tests to evaluate medical devices that interact with blood. It is part of a series aimed at ensuring the safety and biocompatibility of medical products through comprehensive biological evaluation....
What does DIN EN ISO 10993-4 E:2016 cover?
This standard covers: This standard provides guidance on the selection of tests to evaluate medical devices that interact with blood. It is part of a series aimed at ensuring the safety and biocompatibility of medical products through comprehensive biological evaluation. The document outlines specific considerations for...
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?
The current published version is DIN EN ISO 10993-4 E:2016, published on 2016-02-01. Always check for amendments or pending revisions.
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