Podaci o nacrtu

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025)
Oznaka:prEN ISO 10993-3
Odbor:HZN/TO 555
Ime odbora:Medicinski proizvodi
Nacrt objavljen za komentiranje:2025-05-06
Rok za komentiranje:2025-05-27
Broj komentara:0
Contact email:nacrti(at)hzn.hr
Pročitaj nacrt
Obavijesti kolegu
Područje primjene nacrta:

ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Sustav komentiranja nacrta norma – Sufinancirale Europska unija i EFTA    

HZN snosi isključivu odgovornost za ovu aplikaciju. Europska unija ne odgovara za upotrebu informacija koje su u njoj sadržane.