EN ISO 8836:2020

Suction catheters for use in the respiratory tract (ISO 8836:2019)

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE    For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2019)

Dieses Dokument legt Maße und Anforderungen an sowohl offene als auch geschlossene Absaugkatheter aus flexiblen Materialien zur Verwendung bei der Absaugung im Atemtrakt fest.
Absaugkatheter zur Verwendung mit brennbaren Anästhesiegasen oder Anästhesiemitteln, mit Lasern oder elektrochirurgischen Geräten sind nicht Gegenstand dieses Dokuments.
ANMERKUNG   ISO/TR 11991 enthält einen Leitfaden zur Sicherung der Luftwege bei Laserchirurgie in den oberen Atemwegen [4].

Sondes d'aspiration pour les voies respiratoires (ISO 8836:2019)

Le présent document spécifie les dimensions et les exigences applicables aux sondes d'aspiration fermées, mais aussi ouvertes constituées de matériaux souples et destinées à une utilisation dans l'aspiration des voies respiratoires.
Les sondes d'aspiration destinées à une utilisation avec des gaz ou agents anesthésiques inflammables, des lasers ou des appareils électrochirurgicaux ne sont pas couvertes par le présent document.
NOTE       Pour obtenir des recommandations relatives à la façon d'assurer la ventilation au cours d'opérations par laser des voies respiratoires supérieures, se reporter à l'ISO/TR 11991[4].

Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2019)

General Information

• Status: Published
• Publication Date: 06-Oct-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• 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: 07-Oct-2020
• Completion Date: 07-Oct-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8836:2020 - Suction catheters for use in the respiratory tract (ISO 8836:2019)

Relations

• Replaces: EN ISO 8836:2014 - Suction catheters for use in the respiratory tract (ISO 8836:2014)
• Effective Date: 29-Mar-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8836:2020
01-december-2020
Nadomešča:
SIST EN ISO 8836:2015
Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2019)
Suction catheters for use in the respiratory tract (ISO 8836:2019)
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2019)
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2019)
Ta slovenski standard je istoveten z: EN ISO 8836:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8836:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8836:2020

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SIST EN ISO 8836:2020


EN ISO 8836
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2020
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.25 Supersedes EN ISO 8836:2014
English Version

Suction catheters for use in the respiratory tract (ISO
8836:2019)
Sondes d'aspiration pour les voies respiratoires (ISO Absaugkatheter zur Verwendung im Atemtrakt (ISO
8836:2019) 8836:2019)
This European Standard was approved by CEN on 24 June 2020.

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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8836:2020 E
worldwide for CEN national Members.

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SIST EN ISO 8836:2020
EN ISO 8836:2020 (E)
Contents Page
European foreword . 3

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SIST EN ISO 8836:2020
EN ISO 8836:2020 (E)
European foreword
This document (EN ISO 8836:2020) 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 2021, and conflicting national standards shall be
withdrawn at the latest by October 2023.
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.
This document supersedes EN ISO 8836:2014.
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 8836:2019 has been approved by CEN as EN ISO 8836:2020 without any modification.


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SIST EN ISO 8836:2020

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SIST EN ISO 8836:2020
INTERNATIONAL ISO
STANDARD 8836
Fifth edition
2019-12
Suction catheters for use in the
respiratory tract
Sondes d'aspiration pour les voies respiratoires
Reference number
ISO 8836:2019(E)
©
ISO 2019

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SIST EN ISO 8836:2020
ISO 8836:2019(E)

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