Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM)
Edition 2006-07-01

Use and maintenance of medical devices - Risk management system for risks associated with the use of medical devices
Edition 2017-02-04

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2020-08-19

Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process
Edition 2020-12-16

Biological evaluation of medical devices - Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2014-12-05

Biological evaluation of medical devices - Part 4: selection of tests for interactions with blood
Edition 2018-07-13

Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity
Edition 2010-07-01

Biological evaluation of medical devices - Part 6: tests for local effects after implantation
Edition 2017-04-15

Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals
Edition 2008-12-01

Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals - Amendment 1 : applicability of allowable limits for neonates and infants
Edition 2022-01-12