NA 027 Optics and Precision Mechanics Standards Committee

Home > NA 027-04-26 AA > 00170234 > DIN 13114-1 > DIN 13175 > DIN 13181-2 > DIN 32561 > DIN 32567-4 > DIN 5340 > DIN 58118 > > DIN 58723 > DIN 58741-8 > DIN 58743 > DIN 58750-3 > DIN 58762 > DIN 58765 > DIN 58865 > DIN 8310 > DIN 8319-2 > DIN EN 14143 > DIN EN 250 > DIN EN ISO 10328/A1 > DIN EN ISO 10343 > DIN EN ISO 10685-3 > DIN EN ISO 10938 > DIN EN ISO 10993-12 > DIN EN ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011); German version prEN ISO 10993-3:2011

Project begin
2008-01-03

WI
00206046

Planned document number
DIN EN ISO 10993-3

Abstract
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: - genotoxicity, - carcinogenicity and - reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Responsible Committee
NA 027-02-12 AA Biological evaluation of medical devices

Notice of supersedure
Vorgesehen als Ersatz für DIN EN ISO 10993-3:2009-08

Draft standard

DIN EN ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011); German version prEN ISO 10993-3:2011
Publication date : 2011-08

Order from Beuth Verlag