EN ISO 10079-4:2021

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

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.

Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)

Dieses Dokument legt die allgemeinen Anforderungen an medizinische Absauggeräte fest, die für alle Teile der Normenreihe ISO 10079 gelten.
Dieses Dokument ist nicht anzuwenden für Folgendes:
a)   Endstücke wie Absaugkatheter, Drainagen, Küretten und Yankauer-Sauger und Absaugtüllen;
b)   Spritzen;
c)   zahnmedizinische Absauggeräte;
d)   Anästhesiegas-Fortleitungssysteme;
e)   Laborabsaugung;
f)   Autotransfusionssysteme;
g)   Schleimabsauger einschließlich Schleimabsauger für Neugeborene;
h)   Absauggeräte mit Sammelbehälter unterhalb der Vakuumpumpe;
i)   Beatmungsgeräte (für die Geburtshilfe);
j)   Absauggeräte, die nur für endoskopische Verwendung gekennzeichnet sind; und
k)   Rauch-Gasabsaugsysteme.

Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)

Le présent document spécifie des exigences générales pour les appareils d’aspiration médicale qui sont communes à toutes les parties de la série de normes ISO 10079.
Le présent document ne s’applique pas aux éléments suivants:
a) les pièces d’extrémité, telles que les sondes d’aspiration, les drains, les curettes, les «Yankauer» et les embouts d’aspiration;
b) les seringues;
c) les appareils dentaires d’aspiration;
d) les systèmes d’évacuation des gaz d’anesthésie;
e) l’aspiration en laboratoire;
f) les systèmes d’autotransfusion;
g) les extracteurs de mucosités, y compris ceux pour nouveau-nés;
h) les appareils d’aspiration dont le bocal de recueil est en aval de la pompe à vide;
i) les appareils avec ventouse (obstétrique);
j) les appareils d’aspiration à usage endoscopique uniquement (marqués comme tels); et
k) les systèmes d’évacuation de fumée.

Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-4:2021)

General Information

• Status: Published
• Publication Date: 19-Oct-2021
• Withdrawal Date: 29-Apr-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Oct-2021
• Completion Date: 20-Oct-2021
• Directive: 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 10079-4:2021 - Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-4:2021
01-december-2021
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-
4:2021)
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)
Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)
Ta slovenski standard je istoveten z: EN ISO 10079-4:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-4:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-4:2021

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SIST EN ISO 10079-4:2021


EN ISO 10079-4
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Medical suction equipment - Part 4: General requirements
(ISO 10079-4:2021)
Appareils d'aspiration médicale - Partie 4: Exigences Medizinische Absauggeräte - Teil 4: Allgemeine
générales (ISO 10079-4:2021) Anforderungen (ISO 10079-4:2021)
This European Standard was approved by CEN on 26 July 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-4:2021 E
worldwide for CEN national Members.

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SIST EN ISO 10079-4:2021
EN ISO 10079-4:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 10079-4:2021
EN ISO 10079-4:2021 (E)
European foreword
This document (EN ISO 10079-4:2021) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2022, and conflicting national standards shall be
withdrawn at the latest by April 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10079-4:2021 has been approved by CEN as EN ISO 10079-4:2021 without any
modification.


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SIST EN ISO 10079-4:2021

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SIST EN ISO 10079-4:2021
INTERNATIONAL ISO
STANDARD 10079-4
First edition
2021-08
Medical suction equipment —
Part 4:
General requirements
Appareils d’aspir
...