12/03/2024 -
This document specifies:
the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical...
12/03/2024 -
This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to...
12/03/2024 -
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated...
12/03/2024 -
This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to...
11/03/2024 -
This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are...
20/02/2024 -
This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of...
14/02/2024 -
This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic...