Normas ISO

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices-- Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices-- Part 7: Ethylene oxide sterilization residuals

Applicability of allowable limits for neonates and infants

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices-- Part 9: Framework for identification and quantification of potential degradation products