The scope of the proposed work item is to clearly describe the biocontainment systems intended for the ambulance transportation of infectious patients.
Proposal for Scope:
The standard specifies the requirements for design, the minimum performance level and testing of the biocontainment systems.
It aims to ensure maximum protection for operators from exposure to infectious agents, patient’s safety and comfort and ergonomic handling.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
cen:proj:77253
00.60
Close of review
Dec 22, 2022
