This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
Directives 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
PUBLISHED
SRPS EN ISO 10079-4:2022
60.60
Standard published
Mar 31, 2022