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ISO 10993-3:2026

Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
6. 8. 2026.

Опште информације

60.60     6. 8. 2026.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

This document specifies strategies for risk estimation and evaluation of biological harms with respect to:

genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.

This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE            Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.

Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-3:2014

POVUČEN
ISO/TR 10993-33:2015

TRENUTNO

OBJAVLJEN
ISO 10993-3:2026
60.60 Standard objavljen
6. 8. 2026.

Nacionalna preuzimanja

dnaSRPS EN ISO 10993-3:2024  
ISS

Biološko vrednovanje medicinskih sredstava – Deo 3: Ispitivanja genotoksičnosti, karcinogenosti i reproduktivne toksičnosti

50.60   Završetak postupka odobravanja definitivnog teksta nacrta standarda

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