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SRPS EN ISO 10079-4:2022

Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)

Mar 31, 2022

General information

60.60     Mar 31, 2022

ISS

Z076

European Norm

11.040.10  

English  

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Scope

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.

Related directives

Directives related to this standard.

2017/745

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

Life cycle

NOW

PUBLISHED
SRPS EN ISO 10079-4:2022
60.60 Standard published
Mar 31, 2022

Related project

Adopted from EN ISO 10079-4:2021

Adopted from ISO 10079-4:2021