INTERNATIONAL ISO

STANDARD 8536-10

Redline version
compares Second edition to
First edition

Infusion equipment for medical use —

Part 10:
Accessories for fluid lines for single
use with pressure infusion equipment) EW

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Matériel de perfusion à usage médical —
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Partie 10: Accessoires pour tubulures non réutilisables avec un
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matériel de perfusion sous pression

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Reference number
ISO 8536-10:redline:2015(E)

© ISO 2015
ISO 8536-10: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)

Text example 2 — indicates removed text (in red)
— 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.

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DISCLAIMER
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This Redline version provides you with a quick and easy way to compare the main changes
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between this edition of the standard and its previous edition. It doesn’t capture all single
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changes such as punctuation but highlights the modifications providing customers with
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the most valuable information. Therefore it is important to note that this Redline version is
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not the official ISO standard and that the users must consult with the clean version of the
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standard, which is the official standard, for implementation purposes.

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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

 ISO 8536-10:redline:2015(E)


Contents Page

Foreword......................................................................................................................................................................................................................................... iv
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Designation................................................................................................................................................................................................................. 2
43 Materials........................................................................................................................................................................................................................ 2
54 Physical requirements..................................................................................................................................................................................... 2
5.1 4.1 Avoidance of air bubbles................................................................................................................................................................. 2
5.2 4.2 Particulate contamination.............................................................................................................................................................. 3
5.3 4.3 Tensile strength....................................................................................................................................................................................... 3
5.4 4.4 Leakage........................................................................................................................................................................................................... 3
5.5 4.5 Adapters with female and/or male conical fittings.................................................................................................. 3
5.6 4.6 Protective caps......................................................................................................................................................................................... 3
5.7 4.7 Manipulation of stopcocks............................................................................................................................................................. 3
5.8 4.8 Unit with injection site...................................................................................................................................................................... 3
5.9 4.9 Unit with check valve.......................................................................................................................................................................... 3
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65 Chemical requirements.................................................................................................................................................................................. 3

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76 Biological requirements................................................................................................................................................................................ 3

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7.1 6.1 Sterility........................................................................................................................................................................................................... 3
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7.2 6.2 Pyrogens........................................................................................................................................................................................................ 4
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7.3 6.3 Haemolysis.................................................................................................................................................................................................. 4

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87 Packaging...................................................................................................................................................................................................................... 4
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98 Labelling......................................................................................................................................................................................................................... 4
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8.1 General............................................................................................................................................................................................................ 4
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9.1 8.2 Unit Label on unit container......................................................................................................................................................... 4

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9.2 8.3 Shelf Label on shelf or multi-unit container.................................................................................................................... 5

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9 Disposal........................................................................................................................................................................................................................... 5
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Annex A (normative) Physical tests........................................................................................................................................................................ 6

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Annex B (normative) Chemical tests..................................................................................................................................................................... 8

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Annex C (normative) Biological tests.................................................................................................................................................................... 9

Bibliography.............................................................................................................................................................................................................................. 10

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ISO 8536-10: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. ) EW

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Attention is drawn to the possibility that some of the elements of this document may be the subject of

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patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

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any patent rights identified during the development of the document will be in the Introduction and/or
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on the ISO list of patent declarations received (see www.iso.org/patents).
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Any trade name used in this document is information given for the convenience of users and does not
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constitute an endorsement.
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For an explanation on the meaning of ISO specific terms and expressions related to conformity
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assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
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to Trade (TBT) see the following URL: Foreword - Supplementary information

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ISO 8536-10 was prepared by Technical CommitteeThe committee responsible for this document
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is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and
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pharmaceutical use.
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This second edition cancels and replaces the first edition (ISO 8536-10:2004), which has been technically
revised with the following changes:
— The former Clause 3 on designation has been deleted;
— Clause 8 on labelling was amended by a note regarding the usage of the symbol “XXX” according
ISO 7000-2725;
— Clause 9 on disposal has been added;
— A.4 ‘Tests for leakage’ 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 the 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

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 ISO 8536-10: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 ) EW

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— Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact

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INTERNATIONAL STANDARD ISO 8536-10:redline:2015(E)

Infusion equipment for medical use —

Part 10:
Accessories for fluid lines for single use with pressure
infusion equipment

1 Scope
This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion
equipment as specified in ISO 8536-8.
This part of ISO 8536 includes the following:
a) two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC), and stopcocks
manifold (SM); ) EW

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NOTE Designation of a stopcock depends on the number of connections. The number of possible

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functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a
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numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock
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with four possible positions.
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b) units with injection site (UIS) or check valve (UCV);

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c) stoppers (S) or adapters (A).

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In some countries, the national pharmacopoeia or other national regulations are legally binding and
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take precedence over this part of ISO 8536.

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2 Normative references
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The following referenced documentsdocuments, in whole or in part, are normatively referenced in this
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document and are indispensable for the application of this documentits application. For dated references,
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only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 594-21), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 7886-1 7000, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use Graphical
symbols for use on equipment — Registered symbols
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8536-8, Infusion equipment for medical use — Part 8: Infusion equipment sets for single use with
pressure infusion apparatus
ISO 8536-12, Infusion equipment for medical use —Part 12: Check valves
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements

1) To be replaced by ISO 80369-7.

© ISO 2015 – All rights reserved  1

ISO 8536-10:redline:2015(E)


3 Designation
Designation of two-way stopcock (2SC) for infusions under pressure (P):
Two-way stopcock ISO 8536-10 - 2SC -P
Designation of three-way stopcock (3SC) for infusions under pressure (P):
Three-way stopcock ISO 8536-10 - 3SC -P
Designation of four-way stopcock (4SC) for infusions under pressure (P):
Four-way stopcock ISO 8536-10 - 4SC -P
Designation of stopcock manifold (SM) for infusions under pressure (P):
Stopcock manifold ISO 8536-10 - SM -P
Designation of two-stopcock manifold (2SM) for infusions under pressure (P):
Stopcock manifold ISO 8536-10 - 2SM -P
Designation of three-stopcock manifold (3SM) for infusions under pressure (P): ) EW

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Stopcock manifold ISO 8536-10 - 3SM -P

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Designation of four-stopcock manifold (4SM) for infusions under pressure (P):
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Stopcock manifold ISO 8536-10 - 4SM -P

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Designation of unit with injection site (UIS) for infusions under pressure (P):
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Injection unit ISO 8536-10 - UIS -P

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Designation of unit with check valve (UCV) for infusions under pressure (P):
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Injection unit ISO 8536-10 - UCV -P

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Designation of stopper (S) for infusions under pressure (P):

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Stopper ISO 8536-10 - S -P

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Designation of adapter (A) for infusions under pressure (P):

Adapter ISO 8536-10 - A -P

4 3 Materials
The materials from which the accessories as given in Clause 3are manufactured shall comply with the
requirements as specified in Clauses 5Clause 4, 6Clause 5, and 7Clause 6.

5 4 Physical requirements

5.1 4.1 Avoidance of air bubbles

All components of accessories shall be designed such that no air bubbles are detected in flow channels
when tested as specified in A.1.

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 ISO 8536-10:redline:2015(E)


5.2 4.2 Particulate contamination

The accessories shall be manufactured under conditions that minimize particulate contamination.
The fluid pathway surfaces shall be smooth and clean. When tested as specified in A.2, the number of
particles shall not exceed the contamination index.

5.3 4.3 Tensile strength

When tested as specified in A.3, the accessories and connections between components shall withstand
a static tensile force of not less than 15 N for 15 s.
In the case of stopcocks, connections between plug and housing shall withstand this tensile force when
in any position.

5.4 4.4 Leakage

The accessories shall be impermeable to air, microorganisms, and fluids. There shall be no leakage of air
or water. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no
leakage of air or water.

5.5 4.5 Adapters with female and/or male conical fittings

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Adapters shall be provided with a connector with female conical fitting and/or a connector with male
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conical fitting according to ISO 594-2. When tested as specified in A.5, no water shall leak from the point
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5.6 4.6 Protective caps

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ISO 8536-4 applies.

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5.7 4.7 Manipulation of stopcocks

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Stopcocks and stopcock manifolds shall be so designed that when tested as specified in A.65, flow channels
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can be opened and closed without any adverse effect on the functionality of adjacent components.
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5.8 4.8 Unit with injection site

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Units with injection site shall enable injection. When tested as specified in A.76, no more than 10 drops
per batch and no more than 2 drops per unit shall be lost.

5.9 4.9 Unit with check valve

When tested as specified in A.8ISO 8536-12, the valve shall close tightly to prevent any leakage of water.

6 5 Chemical requirements
ISO 8536-4 applies. For test methods, see Annex B.

7 6 Biological requirements

7.1 6.1 Sterility

The accessories in their unit container shall have been subjected to a validated sterilization process (see
BibliographyBibliography).

© ISO 2015 – All rights reserved  3