0 Stavka
Moj nalog
Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 10993-23:2021

Biological evaluation of medical devices — Part 23: Tests for irritation
20. 1. 2021.

Опште информације

60.60     20. 1. 2021.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 10993-23:2021
60.60 Standard objavljen
20. 1. 2021.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 10993-23:2021/Amd 1:2025

Nacionalna preuzimanja

SRPS EN ISO 10993-23:2021  
ISS

Biološko vrednovanje medicinskih sredstava – Deo 23: Ispitivanja iritacije

60.60   Standard objavljen

Z076 Saznaj više