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ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
24. 9. 2014.

Опште информације

90.92     27. 10. 2023.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, 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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-3:2003

TRENUTNO

OBJAVLJEN
ISO 10993-3:2014
90.92 Odluka o izmeni ili reviziji standarda
27. 10. 2023.

REVIDIRAN OD

NAPUŠTEN
ISO/CD 10993-3

PROJEKAT
ISO/CD 10993-3

Nacionalna preuzimanja

SRPS EN ISO 10993-3:2017  
ISS

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

60.60 Standard objavljen

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