This document specifies general and performance requirements and test methods for respiratory infection prevention devices for self- and third party protection. The respiratory infection prevention device for self- and third party protection is intended to cover all age groups.
The respiratory infection prevention device for self- and third party protection is intended to minimize the transmission of infectious airborne pathogens (e.g. bacteria, fungi, spores, viruses). It is intended both as a medical device for use in health care settings and as personal protective equipment for respiratory protection (self- and third party protection). The respiratory infection prevention device for self- and third party protection is equally suitable for use in professional as well as everyday settings especially in epidemic and pandemic situations.
It provides information on different performance classes depending on the intended use.
Finally the document specifies requirements for usability and considers all age groups.
Legislation related to this standard
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
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
ABANDON
cen:proj:74319
30.98
Project deleted
Jan 27, 2023
