ISO 10993-23:2021

International Standard   Current Edition
· Approved on 20 January 2021 ·

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

ISO 10993-23:2021 Files

null Pages
Current Edition

ISO 10993-23:2021 Scope

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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013 
Omani Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-1:2013
GSO 150-1:2013 
Omani Standard
Expiration dates for food products -Part 1 : Mandatory expiration dates
GSO 150-1:2013
 
Gulf Technical Regulation
Expiration dates for food products -Part 1 : Mandatory expiration dates

Recently Published

ISO 9111:2024
 
International Standard
Water reuse in urban areas — Guidelines for benefit evaluation of reclaimed water use
ISO 13426-2:2024
 
International Standard
Geotextiles and geotextile-related products — Strength of internal structural junctions — Part 2: Geocomposites
ISO 24566-2:2024
 
International Standard
Drinking water, wastewater and stormwater systems and services — Adaptation of water services to climate change impacts — Part 2: Stormwater services
ISO 16646:2024
 
International Standard
Fusion installations — Criteria for the design and operation of confinement and ventilation systems of tritium fusion facilities and fusion fuel handling facilities