DIN EN ISO 10993-4:2025-09
DIN · 2025-09-01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017 + Amd 1:2025, Corrected version 2025-04); German version EN ISO 10993-4:2017 + A1:2025
1Key Takeaways
This standard provides guidance on the selection of tests for evaluating the biological interaction of medical devices with blood. It outlines the criteria for determining the appropriate testing methods based on the device's intended use and potential contact with blood. The document includes information on relevant t…
2Scope / Description
This standard provides guidance on the selection of tests for evaluating the biological interaction of medical devices with blood. It outlines the criteria for determining the appropriate testing methods based on the device's intended use and potential contact with blood. The document includes information on relevant test procedures, their applicability, and the factors that influence test selection. It also addresses the interpretation of test results and their relevance to the safety and performance of the medical device. The standard is structured to support a systematic approach to biological evaluation, ensuring consistency and reliability in the assessment process.
3Version History
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6Frequently Asked Questions
What is DIN EN ISO 10993-4:2025-09?
DIN EN ISO 10993-4:2025-09 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017 + Amd 1:2025, Corrected version 2025-04); German version EN ISO 10993-4:2017 + A1:2025 is an international standard developed by German Institute for Standardization. This standard provides guidance on the selection of tests for evaluating the biological interaction of medical devices with blood. It outlines the criteria for determining the appropriate testing methods based on the device's intended use and...
What does DIN EN ISO 10993-4:2025-09 cover?
This standard covers: This standard provides guidance on the selection of tests for evaluating the biological interaction of medical devices with blood. It outlines the criteria for determining the appropriate testing methods based on the device's intended use and potential contact with blood. The document includes...
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 10993-4:2025-09?
The current published version is DIN EN ISO 10993-4:2025-09, published on 2025-09-01. Always check for amendments or pending revisions.
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