Projects

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Sources of hazard information for medical device constituents

10.99 New project approved

ISO/TC 194

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

30.00 Committee draft (CD) registered

ISO/TC 194

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

ISO/TC 194

Clinical investigation of medical devices for human subjects — Good clinical practice

30.60 Close of voting/ comment period

ISO/TC 194

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

40.00 DIS registered

ISO/TC 194

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

40.00 DIS registered

ISO/TC 194

Cleanliness of medical devices — Process design and test methods

10.20 New project ballot initiated

ISO/TC 194

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

00.00 Proposal for new project received

ISO/TC 194

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

00.00 Proposal for new project received

ISO/TC 194

Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

00.00 Proposal for new project received

ISO/TC 194

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

00.00 Proposal for new project received

ISO/TC 194

Mathematical models for the evaluation of toxicokinetics

00.00 Proposal for new project received

ISO/TC 194

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

00.00 Proposal for new project received

ISO/TC 194

Pyrogenicity

00.00 Proposal for new project received

ISO/TC 194

Ensuring quality of analytical chemistry in support of biological evaluation

00.00 Proposal for new project received

ISO/TC 194

Preparation of medical device extracts for chemical analysis to support toxicological risk assessment

00.00 Proposal for new project received

ISO/TC 194

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

ISO/TC 194

Application of in-silico/read-across approaches for identifying a medical device constituent analogue

00.00 Proposal for new project received

ISO/TC 194