Use the form below to find particular standards or projects. Enter your criteria for searching (single or in combination) in the fields below and press the button “Search”. You can also search using the Advance Search facility.
Sources of hazard information for medical device constituents
10.99 New project approved
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
30.00 Committee draft (CD) registered
Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
30.60 Close of voting/ comment period
Clinical investigation of medical devices for human subjects — Good clinical practice
30.60 Close of voting/ comment period
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
40.00 DIS registered
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
40.00 DIS registered
Cleanliness of medical devices — Process design and test methods
10.20 New project ballot initiated
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
00.00 Proposal for new project received
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
00.00 Proposal for new project received
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
00.00 Proposal for new project received
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
00.00 Proposal for new project received
Mathematical models for the evaluation of toxicokinetics
00.00 Proposal for new project received
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
00.00 Proposal for new project received
Ensuring quality of analytical chemistry in support of biological evaluation
00.00 Proposal for new project received
Preparation of medical device extracts for chemical analysis to support toxicological risk assessment
00.00 Proposal for new project received
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
00.00 Proposal for new project received
Application of in-silico/read-across approaches for identifying a medical device constituent analogue
00.00 Proposal for new project received