18/04/2024 -
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers,...
18/04/2024 -
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such...
18/04/2024 -
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies...
11/04/2024 -
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood...
03/04/2024 -
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all...
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 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...
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...