EN ISO 8536-4:2020
(Main)Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
This document 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 document 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.
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2019)
Dieses Dokument legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Infusionsgeräte für Schwerkraftinfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Infusionslösungen und Geräten zur intravenösen Punktion geeignet sind.
Sekundäres Ziel dieses Dokuments ist eine Anleitung zu Festlegungen bezüglich Qualität und Leistungsfähigkeit der Werkstoffe, die für Infusionsgeräte verwendet werden. Außerdem werden Benennun¬gen für die Einzelteile von Infusionsgeräten angegeben.
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2019)
Le présent document spécifie les exigences applicables aux appareils de perfusion à usage médical, non réutilisables, à alimentation par gravité, afin d'assurer leur compatibilité avec les récipients contenant des solutions de perfusion et avec les appareils intraveineux.
Le deuxième objectif du présent document est de donner des recommandations sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de perfusion et de proposer une terminologie concernant les composants de ces derniers.
Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2019)
Ta dokument 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 dokumenta sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za infuzijske sete, ter predstaviti oznake za sestavne dele transfuzijskih setov.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 8536-4:2013
SIST EN ISO 8536-4:2013/A1:2013
Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno
uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2019)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2019)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2019)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2020
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8536-4
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-4:2013
English Version
Infusion equipment for medical use - Part 4: Infusion sets
for single use, gravity feed (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Infusionsgeräte zur medizinischen Verwendung - Teil
Appareils de perfusion non réutilisables, à 4: Infusionsgeräte für Schwerkraftinfusionen zur
alimentation par gravité (ISO 8536-4:2019) einmaligen Verwendung (ISO 8536-4:2019)
This European Standard was approved by CEN on 17 October 2019.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 04 March 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
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 8536-4:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8536-4:2020) 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 July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
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 8536-4:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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 8536-4:2019 has been approved by CEN as EN ISO 8536-4:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 8536-4
Sixth edition
2019-09
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation
par gravité
Reference number
ISO 8536-4:2019(E)
©
ISO 2019
ISO 8536-4:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 8536-4:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Designation . 4
6 Materials . 4
7 Physical requirements . 4
7.1 Particulate contamination . 4
7.2 Leakage . 4
7.3 Tensile strength . 4
7.4 Closure-piercing device . 5
7.5 Air-inlet device . 5
7.6 Tubing . 5
7.7 Fluid filter . 5
7.8 Drip chamber and drip tube . 6
7.9 Flow regulator . 6
7.10 Flow rate of infusion set . 6
7.11 Injection site . 6
7.12 Male conical fitting . 6
7.13 Protective caps . 6
8 Chemical requirements . 6
8.1 Reducing (oxidizable) matter . 6
8.2 Metal ions . 6
8.3 Titration acidity or alkalinity. 6
8.4 Residue on evaporation . 7
8.5 UV absorption of extract solution . 7
9 Biological requirements . 7
9.1 General . 7
9.2 Sterility . 7
9.3 Pyrogenicity . 7
9.4 Haemolysis . 7
9.5 Toxicity . 7
10 Labelling . 7
10.1 General . 7
10.2 Unit container . 7
10.3 Shelf or multi-unit container . 8
11 Packaging . 8
12 Disposal . 9
Annex A (normative) Physical tests .
...
SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 8536-4:2013
SIST EN ISO 8536-4:2013/A1:2013
Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno
uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2019)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2019)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2019)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2020
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8536-4
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-4:2013
English Version
Infusion equipment for medical use - Part 4: Infusion sets
for single use, gravity feed (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Infusionsgeräte zur medizinischen Verwendung - Teil
Appareils de perfusion non réutilisables, à 4: Infusionsgeräte für Schwerkraftinfusionen zur
alimentation par gravité (ISO 8536-4:2019) einmaligen Verwendung (ISO 8536-4:2019)
This European Standard was approved by CEN on 17 October 2019.
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 8536-4:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8536-4:2020) 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 July 2020, and conflicting national standards shall be
withdrawn at the latest by January 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 8536-4:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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 8536-4:2019 has been approved by CEN as EN ISO 8536-4:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 8536-4
Sixth edition
2019-09
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation
par gravité
Reference number
ISO 8536-4:2019(E)
©
ISO 2019
ISO 8536-4:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 8536-4:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Designation . 4
6 Materials . 4
7 Physical requirements . 4
7.1 Particulate contamination . 4
7.2 Leakage . 4
7.3 Tensile strength . 4
7.4 Closure-piercing device . 5
7.5 Air-inlet device . 5
7.6 Tubing . 5
7.7 Fluid filter . 5
7.8 Drip chamber and drip tube . 6
7.9 Flow regulator . 6
7.10 Flow rate of infusion set . 6
7.11 Injection site . 6
7.12 Male conical fitting . 6
7.13 Protective caps . 6
8 Chemical requirements . 6
8.1 Reducing (oxidizable) matter . 6
8.2 Metal ions . 6
8.3 Titration acidity or alkalinity. 6
8.4 Residue on evaporation . 7
8.5 UV absorption of extract solution . 7
9 Biological requirements . 7
9.1 General . 7
9.2 Sterility . 7
9.3 Pyrogenicity . 7
9.4 Haemolysis . 7
9.5 Toxicity . 7
10 Labelling . 7
10.1 General . 7
10.2 Unit container . 7
10.3 Shelf or multi-unit container . 8
11 Packaging . 8
12 Disposal . 9
Annex A (normative) Physical tests .10
Annex B (normative) Chemical tests .
...
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