Back

ISO 10993-23:2021

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

General information
Valid from 20.01.2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
20.01.2021
Main
This document 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.
*
*
*
PDF
197.77 € incl tax
Paper
197.77 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

ISO/TR 20772:2018

Ophthalmic optics -- Spectacle lenses -- Short wavelength visible solar radiation and the eye
Newest version Valid from 25.09.2018
Main

EVS-EN 12472:2020

Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items
Newest version Valid from 02.10.2020
Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
Newest version Valid from 31.12.2020
Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Newest version Valid from 02.10.2020