SIST EN ISO 8536-4:2013/A1:2013

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)

This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010/Amd 1:2013)

Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2010/Amd 1:2013)

Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije - Dopolnilo A1 (ISO 8536-4:2010/Amd 1:2013)

Ta del standarda ISO 8536 določa zahteve za infuzijske sete za enkratno uporabo, delujoče na osnovi gravitacije, za uporabo v medicini za zagotavljanje združljivosti z vsebniki za infuzijske raztopine in intravenozno opremo. Druga cilja tega dela standarda ISO 8536 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za infuzijske sete, ter predstaviti oznake za sestavne dele transfuzijskih setov. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Mar-2012
• Publication Date: 21-May-2013
• Withdrawal Date: 10-Feb-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 11-Feb-2020
• Due Date: 05-Mar-2020
• Completion Date: 11-Feb-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: EN ISO 8536-4:2013/A1:2013 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)

Relations

• Amends: SIST EN ISO 8536-4:2013 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
• Effective Date: 01-Jun-2013
• Replaced By: SIST EN ISO 8536-4:2020 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN ISO 8536-4:2020 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
• Effective Date: 01-Mar-2020
• Amends: SIST EN ISO 8536-4:2013 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-4:2013/A1:2013
01-junij-2013
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH'RSROQLOR$,62$PG

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010/Amd 1:2013)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010/Amd 1:2013)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2013/A1:2013
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-4:2013/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-4:2013/A1:2013

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SIST EN ISO 8536-4:2013/A1:2013


EUROPEAN STANDARD
EN ISO 8536-4:2013/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2013
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2010/Amd 1:2013) Verwendung (ISO 8536-4:2010/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 8536-4:2013; it was approved by CEN on 9 February 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2013/A1:2013: E
worldwide for CEN national Members.

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SIST EN ISO 8536-4:2013/A1:2013
EN ISO 8536-4:2013/A1:2013 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

2

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SIST EN ISO 8536-4:2013/A1:2013
EN ISO 8536-4:2013/A1:2013 (E)
Foreword
This document (EN ISO 8536-4:2013/A1:2013) 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 September 2013, and conflicting national standards shall be
withdrawn at the latest by September 2013.
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.
For relationship with EU Directive, 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 Standard: 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 the United
Kingdom.
Endorsement notice
The text of ISO 8536-4:2010/Amd 1:2013 has been approved by CEN as EN ISO 8536-4:2013/A1:2013
without any modification.
3

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SIST EN ISO 8536-4:2013/A1:2013
EN ISO 8536-4:2013/A1:2013 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/sub-clause(s) of th
...