EN ISO 8536-12:2021

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.
The functional requirements in this document also apply to inline check valves.

Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile zur einmaligen Verwendung (ISO 8536-12:2021)

Dieses Dokument legt Anforderungen für Rückschlagventile fest, die zur einmaligen Verwendung bestimmt sind und sowohl mit Infusionsgeräten für die Schwerkraftinfusion als auch mit Druckinfusionsapparaten verwendet werden.
Die funktionalen Anforderungen in diesem Dokument gelten auch für Inline-Rückschlagventile.

Matériel de perfusion à usage médical - Partie 12: Clapet antiretour à usage unique (ISO 8536-12:2021)

Le présent document spécifie les exigences applicables aux clapets antiretour à usage unique et utilisés avec un matériel de perfusion à alimentation par gravité et avec un appareil de perfusion sous pression.
Les exigences fonctionnelles du présent document s'appliquent également aux clapets antiretour en ligne.

Infuzijska oprema za uporabo v medicini - 12. del: Kontrolni ventili za enkratno uporabo (ISO 8536-12:2021)

General Information

• Status: Published
• Publication Date: 16-Feb-2021
• Withdrawal Date: 30-Aug-2021
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Feb-2021
• Completion Date: 17-Feb-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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 8536-12:2021 - Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-12:2021
01-maj-2021
Infuzijska oprema za uporabo v medicini - 12. del: Kontrolni ventili za enkratno
uporabo (ISO 8536-12:2021)
Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-
12:2021)
Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile zur
einmaligen Verwendung (ISO 8536-12:2021)
Matériel de perfusion à usage médical - Partie 12: Clapet antiretour non réutilisables
(ISO 8536-12:2021)
Ta slovenski standard je istoveten z: EN ISO 8536-12:2021
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-12:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-12:2021

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SIST EN ISO 8536-12:2021


EN ISO 8536-12
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2021
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Infusion equipment for medical use - Part 12: Check valves
for single use (ISO 8536-12:2021)
Matériel de perfusion à usage médical - Partie 12: Infusionsgeräte zur medizinischen Verwendung - Teil
Clapet antiretour à usage unique (ISO 8536-12:2021) 12: Rückschlagventile zur einmaligen Verwendung
(ISO 8536-12:2021)
This European Standard was approved by CEN on 25 January 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 8536-12:2021 E
worldwide for CEN national Members.

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SIST EN ISO 8536-12:2021
EN ISO 8536-12:2021 (E)
Contents Page
European foreword . 3

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SIST EN ISO 8536-12:2021
EN ISO 8536-12:2021 (E)
European foreword
This document (EN ISO 8536-12:2021) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
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 August 2021, and conflicting national standards shall
be withdrawn at the latest by August 2021.
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.
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 8536-12:2021 has been approved by CEN as EN ISO 8536-12:2021 without any
modification.

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SIST EN ISO 8536-12:2021

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SIST EN ISO 8536-12:2021
INTERNATIONAL ISO
STANDARD 8536-12
Second edition
2021-02
Infusion equipment for medical use —
Part
...