NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 14155 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-4 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More 
ISO 10993-5 2009-06 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More 
ISO 10993-6 2016-12 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More 
ISO 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More 
ISO 10993-7 AMD 1 2019-12 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants More 
ISO 10993-7 Technical Corrigendum 1 2009-11 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 More 
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More