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BSI - BS EN ISO 10993-6 - TC

Tracked Changes (Redline) - Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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Organization: BSI
Publication Date: 24 February 2020
Status: active
Page Count: 94
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

BS EN ISO 10993-6 - TC
February 24, 2020
Tracked Changes (Redline) - Biological evaluation of medical devices Part 6: Tests for local effects after implantation
A description is not available for this item.

References

This document references:
ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document references:
EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by CEN on December 1, 2020
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
EN ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by CEN on June 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
EN ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by CEN on December 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document references:
EN ISO 10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements
Published by CEN on November 1, 2022
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the...
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