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EVS-EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

General information

Valid from 15.04.2021
Base Documents
ISO 10993-23:2021; EN ISO 10993-23:2021
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
Amendment
EN ISO 10993-23:2021/prA1
15.04.2021
Main
EVS-EN ISO 10993-23:2021

ISO 10993-23 specifies the procedure for the assessment of medical devices regarding their potential to produce irritation by using an in vitro reconstructed human epidermis model. The tests included in the standard are important tools for the development of safe products.

ISO 10993-23 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.

The text of ISO 10993-23:2021 has been approved in Europe as EN ISO 10993-23:2021 without any changes.

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Standard monitoring
English (PDF 274 KB)

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Amendment

EN ISO 10993-23:2021/prA1

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAmd1:2024)
Newest version Draft
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
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 2018-10)
Newest version Valid from 31.12.2020
Main

EVS-EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Valid from 15.06.2020

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EVS-EN ISO 10993-10:2023

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EVS-EN ISO 10993-12:2021

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Newest version Valid from 01.07.2021
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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 2018-10)
Newest version Valid from 31.12.2020
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EVS-EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Newest version Valid from 07.08.2009

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English