11.100.20 Biological evaluation of medical devices

BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process

BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN ISO 10993-9. Biological evaluation of medical devices Part 9. Framework for identification and quantification of potential degradation products

BS EN ISO 10993-15. Biological evaluation of medical devices Part 15. Identification and quantification of degradation products from metals and alloys

BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices Part 7. Ethylene oxide sterilization residuals

BS EN ISO 10993-18. Biological evaluation of medical devices Part 18. Chemical characterization of medical device materials within a risk management process

BS EN ISO 20776-1. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 1. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives Part 1. Application of risk management

BS ENISO 22442-2. Medical devices utilizing animal tissues and their derivatives Part 2. Controls on sourcing, collection and handling

BS EN ISO 10993-23. Biological evaluation of medical devices Part 23. Tests for irritation

BS EN ISO 10993-12. Biological evaluation of medical devices Part 12. Sample preparation and reference materials