ISO/FDIS 10993-16

Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables

Опште информације

Trenutna faza: 50.00 Effective date: 17. 8. 2026.

Inicijator: ISO

Pripada: ISO/TC 194

Vrsta: Međunarodni standard

Apstrakt

This document describes the considerations to include the toxicokinetic evaluation of single chemical which can include its degradant or metabolite known to be released from a medical device. This document provides the principles for designing and performing a toxicokinetic evaluation for medical devices.

Životni ciklus

PRETHODNO

OBJAVLJEN
ISO 10993-16:2017

TRENUTNO

PROJEKAT
ISO/FDIS 10993-16
50.00 Evidentiranje podataka o definitivnom tekstu nacrta standarda
17. 8. 2026.

Nacionalna preuzimanja

naSRPS EN ISO 10993-16:2024

ISS

Biološko vrednovanje medicinskih sredstava – Deo 16: Koncept toksikološko-kinetičke studije za degradacione proizvode i ekstrahovane primese

40.60 Završetak javne rasprave

Z076 Saznaj više