ISO 10993-23:2021 ✓ Most Recent

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Biological evaluation of medical devices - Part 23: Tests for irritation

standard by International Organization for Standardization , 01/01/2021

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Full Description

ISO 10993-23:2021 specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:
  • pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
  • details of in vitro and in vivo irritation test procedures;
  • key factors for the interpretation of the results.
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Amendments, rulings, supplements, and errata

  1. ISO 10993-23:2021/Amd1:2025


    - Amendment 1: Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models

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Product Details

Edition:

1st

Published:

01/01/2021

Number of Pages:

68

File Size:

1 file

Same As:

BS EN ISO 10993-23:2021, DIN EN ISO 10993-23

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus