EN ISO 8536-13:2016

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2016)

Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non réutilisables avec contact à fluide (ISO 8536-13:2016)

ISO 8536-13:2016 spécifie les exigences applicables aux régulateurs de débit gradués non stériles, non réutilisables, utilisés en tant que sous-composants dans les ensembles de perfusion stérilisés non réutilisables pour contrôler le débit des solutions de perfusion intraveineuses avec contact à fluide, à alimentation par gravité.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales présentent un caractère obligatoire et peuvent prévaloir sur l'ISO 8536-13:2016.

Infuzijska oprema za uporabo v medicini - 13. del: Regulatorji graduiranega pretoka za enkratno uporabo s tekočinskim stikom (ISO 8536-13:2016)

Ta del standarda ISO 8536 določa zahteve za regulatorje graduiranega pretoka za enkratno uporabo za nadzorovanje pretoka intravenoznih infuzijskih raztopin.

General Information

• Status: Published
• Publication Date: 18-Oct-2016
• Withdrawal Date: 29-Apr-2017
• 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: 19-Oct-2016
• Completion Date: 19-Oct-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8536-13:2017 - Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

Relations

• Revised: prEN ISO 8536-13 - Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-13:2017
01-januar-2017
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO5HJXODWRUMLJUDGXLUDQHJD
SUHWRND]DHQNUDWQRXSRUDERVWHNRþLQVNLPVWLNRP,62
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use
with fluid contact (ISO 8536-13:2016)
Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur
einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2016)
Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non
réutilisables avec contact à fluide (ISO 8536-13:2016)
Ta slovenski standard je istoveten z: EN ISO 8536-13:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-13:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-13:2017

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SIST EN ISO 8536-13:2017


EN ISO 8536-13
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2016
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Infusion equipment for medical use - Part 13: Graduated
flow regulators for single use with fluid contact (ISO 8536-
13:2016)
Matériel de perfusion à usage médical - Partie 13: Infusionsgeräte zur medizinischen Verwendung - Teil
Régulateurs de débit gradués non réutilisables avec 13: Graduierte Durchflussregler zur einmaligen
contact à fluide (ISO 8536-13:2016) Verwendung mit Flüssigkeitskontakt (ISO 8536-
13:2016)
This European Standard was approved by CEN on 17 September 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-13:2016 E
worldwide for CEN national Members.

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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (E)
European foreword
This document (EN ISO 8536-13:2016) 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 April 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Sta
...