ISO 8536-11:2015
(Main)Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment
Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment
ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.
Matériel de perfusion à usage médical — Partie 11: Filtres à perfusion non réutilisables avec un matériel de perfusion sous pression
L'ISO 8536-11:2015 s'applique aux filtres à perfusion stériles à usage unique soumis à une pression maximale de 200 kPa (2 bar) sur les tubulures du matériel de perfusion sous pression et des appareils de perfusion spécifiés dans l'ISO 8536‑8. Elle n'aborde pas l'efficacité des filtres en matière de séparation des particules ou des germes.
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INTERNATIONAL ISO
STANDARD 8536-11
Redline version
compares Second edition to
First edition
Infusion equipment for medical use —
Part 11:
Infusion filters for single use with
pressure infusion equipment
Matériel de perfusion à usage médical —
Partie 11: Filtres à perfusion non réutilisables avec un matériel de
perfusion sous pression
Reference number
ISO 8536-11:redline:2015(E)
©
ISO 2015
---------------------- Page: 1 ----------------------
ISO 8536-11:redline:2015(E)
IMPORTANT — PLEASE NOTE
This is a mark-up copy and uses the following colour coding:
Text example 1 — indicates added text (in green)
— indicates removed text (in red)
Text example 2
— indicates added graphic figure
— indicates removed graphic figure
1.x . — Heading numbers containg modifications are highlighted in yellow in
the Table of Contents
All changes in this document have yet to reach concensus by vote and as such should only
be used internally for review purposes.
DISCLAIMER
This Redline version provides you with a quick and easy way to compare the main changes
between this edition of the standard and its previous edition. It doesn’t capture all single
changes such as punctuation but highlights the modifications providing customers with
the most valuable information. Therefore it is important to note that this Redline version is
not the official ISO standard and that the users must consult with the clean version of the
standard, which is the official standard, for implementation purposes.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8536-11:redline:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Designation . 1
4 3 Design . 1
5 4 Materials . 1
6 5 Physical requirements . 2
6.1 5.1 Transparency . 2
6.2 5.2 Particulate contamination . 2
6.3 5.3 Tensile strength . 2
6.4 5.4 Leakage . 2
6.5 5.5 Adapters with female and/or male conical fittings . 2
6.6 5.6 Protective caps . 2
7 6 Chemical requirements . 2
8 7 Biological requirements . 2
8.1 7.1 Sterility . 2
8.2 7.2 Pyrogens . 2
8.3 7.3 Haemolysis . 2
9 8 Packaging . 3
10 9 Labelling . 3
9.1 General . 3
10.1 9.2 .
Unit Label on unit container . 3
10.2 9.3 .
Shelf Label on shelf or multi-unit container . 4
10 Disposal . 4
Annex A (normative) Physical tests . 5
Annex B (normative) Chemical tests . 6
Annex C (normative) Biological tests . 7
Bibliography . 8
© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 8536-11:redline:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards areThe procedures used to develop this document and those intended for its
further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval
criteria needed for the different types of ISO documents should be noted. This document was drafted
in accordance with the rules given ineditorial rules of the ISO/IEC Directives, Part 2 (see www.iso.
org/directives).
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information.
ISO 8536-11 was prepared by Technical CommitteeThe committee responsible for this document
is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and
pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 8536-11:2004), which has been technically
revised with the following changes:
— The former Clause 3 on designation has been deleted;
— Clause 9 on labelling was amended by addition of information regarding the usage of the symbol
“XXX” according ISO 7000, symbol 2725;
— Clause 10 on disposal has been added;
— A.4 has been amended;
— The former A.5 specifying a test for leakage of adapters with female and/or male conical fittings has
been deleted;
— Normative references and Bibliography have been updated;
— document has been editorially revised.
ISO 8536 consists of the following parts under the general title Infusion equipment for medical use:
— Part 1: Infusion glass bottles
— Part 2: Closures for infusion bottles
iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8536-11:redline:2015(E)
— Part 3: Aluminium caps for infusion bottles
— Part 4: Infusion sets for single use, gravity feed
— Part 5: Burette infusion sets for single use, gravity feed
— Part 6: Freeze drying closures for infusion bottles
— Part 7: Caps made of aluminium-plastics combinations for infusion bottles
— Part 8: Infusion equipmentsets for single use with pressure infusion apparatus
— Part 9: Fluid lines for single use with pressure infusion equipment
— Part 10: Accessories for fluid lines for single use with pressure infusion equipment
— Part 11: Infusion filters for single use with pressure infusion equipment
— Part 12: Check valves
The following parts are under preparation:
— Part 13: Graduated flow regulators for single use with infusion sets
— Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
© ISO 2015 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 8536-11:redline:2015(E)
Infusion equipment for medical use —
Part 11:
Infusion filters for single use with pressure infusion
equipment
1 Scope
This part of ISO 8536 applies to sterilized infusion filters for
...
INTERNATIONAL ISO
STANDARD 8536-11
Second edition
2015-06-15
Infusion equipment for medical use —
Part 11:
Infusion filters for single use with
pressure infusion equipment
Matériel de perfusion à usage médical —
Partie 11: Filtres à perfusion non réutilisables avec un matériel de
perfusion sous pression
Reference number
ISO 8536-11:2015(E)
©
ISO 2015
---------------------- Page: 1 ----------------------
ISO 8536-11:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8536-11:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Design . 1
4 Materials . 1
5 Physical requirements . 1
5.1 Transparency . 1
5.2 Particulate contamination . 2
5.3 Tensile strength . 2
5.4 Leakage . 2
5.5 Adapters with female and/or male conical fittings . 2
5.6 Protective caps . 2
6 Chemical requirements . 2
7 Biological requirements . 2
7.1 Sterility . 2
7.2 Pyrogens . 2
7.3 Haemolysis . 2
8 Packaging . 2
9 Labelling . 3
9.1 General . 3
9.2 Label on unit container . 3
9.3 Label on shelf or multi-unit container . 3
10 Disposal . 4
Annex A (normative) Physical tests . 5
Annex B (normative) Chemical tests . 6
Annex C (normative) Biological tests . 7
Bibliography . 8
© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 8536-11:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 8536-11:2004), which has been technically
revised with the following changes:
— The former Clause 3 on designation has been deleted;
— Clause 9 on labelling was amended by addition of information regarding the usage of the symbol
“XXX” according ISO 7000, symbol 2725;
— Clause 10 on disposal has been added;
— A.4 has been amended;
— The former A.5 specifying a test for leakage of adapters with female and/or male conical fittings has
been deleted;
— Normative references and Bibliography have been updated;
— document has been editorially revised.
ISO 8536 consists of the following parts under the general title Infusion equipment for medical use:
— Part 1: Infusion glass bottles
— Part 2: Closures for infusion bottles
— Part 3: Aluminium caps for infusion bottles
— Part 4: Infusion sets for single use, gravity feed
— Part 5: Burette infusion sets for single use, gravity feed
— Part 6: Freeze drying closures for infusion bottles
iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8536-11:2015(E)
— Part 7: Caps made of aluminium-plastics combinations for infusion bottles
— Part 8: Infusion sets for single use with pressure infusion apparatus
— Part 9: Fluid lines for single use with pressure infusion equipment
— Part 10: Accessories for fluid lines for single use with pressure infusion equipment
— Part 11: Infusion filters for single use with pressure infusion equipment
— Part 12: Check valves
The following parts are under preparation:
— Part 13: Graduated flow regulators for single
...
NORME ISO
INTERNATIONALE 8536-11
Deuxième édition
2015-06-15
Matériel de perfusion à usage
médical —
Partie 11:
Filtres à perfusion non réutilisables
avec un matériel de perfusion sous
pression
Infusion equipment for medical use —
Part 11: Infusion filters for single use with pressure infusion equipment
Numéro de référence
ISO 8536-11:2015(F)
©
ISO 2015
---------------------- Page: 1 ----------------------
ISO 8536-11:2015(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2015, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 8536-11:2015(F)
Sommaire Page
Avant-propos .iv
1 Domaine d’application . 1
2 Références normatives . 1
3 Conception . 1
4 Matériaux . 1
5 Exigences physiques . 2
5.1 Transparence . 2
5.2 Contamination particulaire . 2
5.3 Résistance à la rupture . 2
5.4 Étanchéité . 2
5.5 Adaptateurs à raccords coniques mâle et/ou femelle. 2
5.6 Protecteurs . 2
6 Exigences chimiques . 2
7 Exigences biologiques . 2
7.1 Stérilité . 2
7.2 Pyrogènes . 2
7.3 Hémolyse . 2
8 Emballage. 3
9 Étiquetage . 3
9.1 Généralités . 3
9.2 Étiquetage de l’emballage primaire . 3
9.3 Étiquetage de l’emballage secondaire. 3
10 Mise au rebut . 4
Annexe A (normative) Essais physiques . 5
Annexe B (normative) Essais chimiques . 6
Annexe C (normative) Essais biologiques . 7
Bibliographie . 8
© ISO 2015 – Tous droits réservés iii
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ISO 8536-11:2015(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui concerne
la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l’élaboration
du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de brevets reçues par
l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à l’évaluation de
la conformité, ou pour toute information au sujet de l’adhésion de l’ISO aux principes de l’OMC concernant
les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos — Informations
supplémentaires.
Le comité responsable du présent document est l’ISO/TC 76, Appareils de transfusion, de perfusion et
d’injection et appareils destinés au traitement du sang à usage médical et pharmaceutique
Cette deuxième édition annule et remplace la première édition (ISO 8536-11:2004) qui a fait l’objet d’une
révision technique en appliquant les modifications suivantes:
— suppression du précédent Article 3 relatif à la désignation;
— modification de l’Article 9 relatif à l’étiquetage par l’ajout d’une information concernant l’utilisation
du symbole « XXX » selon l’ISO 7000, symbole 2725;
— ajout de l’Article 10 relatif à la mise au rebut;
— modification de A.4;
— suppression du précédent A.5 spécifiant un essai d’étanchéité des adaptateurs à raccords coniques
mâle et/ou femelle;
— mise à jour des références normatives et de la bibliographie;
— révision rédactionnelle du document.
L’ISO 8536 comprend les parties suivantes, présentées sous le titre général Matériel de perfusion à
usage médical:
— Partie 1: Flacons en verre pour perfusion
— Partie 2: Bouchons pour flacons de perfusion
— Partie 3: Capsules en aluminium pour flacons de perfusion
iv © ISO 2015 – Tous droits réservés
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ISO 8536-11:2015(F)
— Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité
— Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité
— Partie 6: Bouchons à lyophilisation pour flacons de perfusion
— Partie 7: Capsules en combinaison aluminium-plastique pour flacons de perfusion
— Partie 8: Appareils de perfusion non réutilisables avec des appareils de perfusion sous pression
— Partie 9: Tubulures non réutilisables avec un matériel de perfusion sous pression
— Partie 10: Accessoires pour tubulures non réutilisables avec un matériel de perfusion sous pression
— Partie 11: Filtres à perfusion non réutilisables avec un matériel de perfusion sous pression
— Partie 12: Clapet antiretour
Les parties suivantes sont en cours de préparation:
— Partie 13: Régulateurs de débit gradués non réutilisables pour appareils de perfusion
— Partie 14: Crochets et limiteurs de débit pour matériel de transfusion et de perfusion sans contact à fluide
© ISO 2015 – Tous droits réservés v
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NORME INTERNATIONALE ISO 8536-11:2015(F)
M
...
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