SIST EN ISO 8536-10:2015
(Main)Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
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, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
NOTE Designation of a stopcock depends on the number of connections. The number of possible
functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a
numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock
with four possible positions.
b) units with injection site or check valve;
c) stoppers or adapters.
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 10: Zubehörteile für Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2015)
Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bestimmte Zubehörteile für Übertragungsleitungen und Druckinfusionsapparate nach ISO 8536-8.
Dieser Teil von ISO 8536 erfasst das Folgende:
a) Zweiwegehähne, Dreiwegehähne, Vierwegehähne und Hahnbänke;
ANMERKUNG Die Bezeichnung eines Hahns hängt von der Anzahl der Verbindungen ab. Die Anzahl der möglichen Funktionsstellungen kann zusätzlich durch einen Schrägstrich und darauf folgend durch die Zahl der möglichen Hahnstellungen erfolgen, z. B. 3/4-Wegehahn für einen Dreiwegehahn mit vier möglichen Stellungen.
b) Zuspritzteil mit Septum oder Ventil;
c) Stopfen oder Adapter.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 8536.
Matériel de perfusion à usage médical - Partie 10: Accessoires de tubulures pour utilisation avec des appareils de perfusion sous pression (ISO 8536-10:2015)
L'ISO 8536-10:2015 s'applique aux accessoires non réutilisables stériles des tubulures et du matériel de perfusion sous pression spécifiés dans l'ISO 8536‑8.
L'ISO 8536-10:2015 traite des éléments suivants:
a) les robinets à deux, trois, quatre voies et les rampes de robinets;
b) les unités avec site d'injection ou avec clapet antiretour;
c) les bouchons ou les adaptateurs.
Infuzijska oprema za uporabo v medicini - 10. del: Dodatki za »fluidne« cevke za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-10:2015)
Ta del standarda ISO 8536 se uporablja za sterilizirane dodatke za enkratno uporabo s »fluidnimi« cevkami in infuzijsko opremo, delujočo na osnovi tlaka, kot je opredeljeno v standardu ISO 8536-8.
Ta del standarda ISO 8536 vključuje naslednje elemente:
a) dvosmerne petelinčke, trismerne petelinčke, štirismerne petelinčke in zbiralnik petelinčka;
OPOMBA: Oznaka petelinčka je odvisna od števila povezav. Število možnih funkcionalnih položajev se lahko izrazi z dodatkom dopolnilne opombe z uporabo poševnice in številke, ki navaja število možnih položajev petelinčkov, npr. 3/4 petelinček pomeni trismerni petelinček s štirimi možnimi položaji.
b) enote z mestom injiciranja ali protipovratnim ventilom;
c) zapirala ali adapterje.
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-10:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-10:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO 'RGDWNL]DªIOXLGQH©FHYNH]D
HQNUDWQRXSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND ,62
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use
with pressure infusion equipment (ISO 8536-10:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für
Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO
8536-10:2015)
Matériel de perfusion à usage médical - Partie 10: Accessoires de tubulures pour
utilisation avec des appareils de perfusion sous pression (ISO 8536-10:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-10:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-10:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 8536-10:2015
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SIST EN ISO 8536-10:2015
EUROPEAN STANDARD
EN ISO 8536-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-10:2004
English Version
Infusion equipment for medical use - Part 10: Accessories for
fluid lines for single use with pressure infusion equipment (ISO
8536-10:2015)
Matériel de perfusion à usage médical - Partie 10 : Infusionsgeräte zur medizinischen Verwendung - Teil 10:
Accessoires pour tubulures non réutilisables avec un Zubehörteile für Übertragungsleitungen zur einmaligen
matériel de perfusion sous pression (ISO 8536-10:2015) Verwendung mit Druckinfusionsapparaten (ISO 8536-
10:2015)
This European Standard was approved by CEN on 16 April 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-10:2015 E
worldwide for CEN national Members.
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SIST EN ISO 8536-10:2015
EN ISO 8536-10:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .5
2
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SIST EN ISO 8536-10:2015
EN ISO 8536-10:2015 (E)
European foreword
This document (EN ISO 8536-10:2015) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection 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 December 2015, and conflicting national standards shall be withdrawn
at the latest by December 2015.
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 supersedes EN ISO 8536-10:2004.
In this edition the following changes have been made:
— 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 specifyin 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.
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 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.
3
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SIST EN ISO 8536-10:2015
EN ISO 8536-10:2015 (E)
Endorsement notice
The text of ISO 8536-10:2015 has been approved by CEN as EN ISO 8536-10:2015 without any modification.
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2
EN ISO
ISO 594-2 — ISO 594-2:1998
ISO 7000 — ISO 7000:2014
ISO 8536-4 EN ISO 8536-4:2013 and ISO 8536-4:2010 and
ISO 8536-4:2013/A1:2013 Amd.1:2013
ISO 8536-8 EN ISO 8536-8:2015 ISO 8536-8:2015
ISO 8536-12 — ISO 8536-12:2007 and
Amd.1:2012
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus
Amd.1:2006
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
4
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SIST EN ISO 8536-10:2015
EN ISO 8536-10:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
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 Communities 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 on medical
devices
Clause(s)/subclause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
Clause 3, 4.1, 4.2, 4.3, 4.4, 4.5, 7.2 The part of ER 7.2 relating to
4.7, 4.8, Clause 6 packaging is not addressed. For
packaging see Clause 7 of this
standard.
Clause 3, Clause 6 7.3 ER covered by biological
evaluation.
4.3, 4.4, A.3, A.4 7.5 Only the first sentence is
covered. Presumption of
conformity with the Essential
Requirements relating to the
biological evaluation can only be
provided if the manufacturer
chooses to apply the ISO 10993
series of standards
4.2, 4.3 7.6
4.2, 4.3, 4.4 8.1 The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are not
covered. Only sterility of
products is covered
8.3
6.1 8.4 Only the sterilisation method is
covered
4.2 8.5
8.2, 8.3 8.7
4.5, 4.8, 8.2 g) 9.1 The second sentence of ER 9.1
is not addressed
Clause 3, 4.1, 4.2, 4.3, 4.4, 4.5, 9.2
4.7, 4.8
5
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SIST EN ISO 8536-10:2015
EN ISO 8536-10:2015 (E)
Clause(s)/subclause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
4.3, A.3 12.7.1 Only tensile strength is
addressed
Clause 8 13.1
8.2 d), e), f), g), 8.3 c), d) 13.2
8.2, 8.3 13.3 The part of 13.3 a) relating to the
authorized representative is not
addressed. Presumption of
conformity to the rest of 13.3 a)
is only provided if the name and
address of the manufacturer are
given
13.3 d) is only covered if the
batch number is preceded by the
word 'LOT'
13.3 f) Requirement „indication
of single use must be consistent
across the Community“ is not
addressed in the standard
13.3 g), h) is not addressed in
the standard
8.2, 8.3 13.4 13.4 is addressed regarding to
the label
8.2, 8.3 13.5 13.5 is not addressed regarding
to the detachable components
8.2, 8.3 13.6 13.6 e), f), h), i), j), l), m), o) are
not applicable for devices
according to this standard
13.6 q) is not addressed
WARNING Other requirements and other EC Directives may be applicable to the product(s) falling
within the scope of this standard.
6
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SIST EN ISO 8536-10:2015
INTERNATIONAL ISO
STANDARD 8536-10
Second edition
2015-06-15
Infusion equipment for medical use —
Part 10:
Accessories for fluid lines for single
use with pressure infusion equipment
Matériel de perfusion à usage médical —
Partie 10: Accessoires pour tubulures non réutilisables avec un
matériel de perfusion sous pression
Reference number
ISO 8536-10:2015(E)
©
ISO 2015
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SIST EN ISO 8536-10:2015
ISO 8536-10:2015(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: 10 ----------------------
SIST EN ISO 8536-10:2015
ISO 8536-10:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Materials . 2
4 Physical requirements . 2
4.1 Avoidance of air bubbles . 2
4.2 Particulate contamination . 2
4.3 Tensile strength . 2
4.4 Leakage . 2
4.5 Adapters with female and/or male conical fittings . 2
4.6 Protective caps . 2
4.7 Manipulation of stopcocks . 2
4.8 Unit with injection site . 2
4.9 Unit with check valve . 2
5 Chemical requirements . 3
6 Biological requirements . 3
6.1 Sterility . 3
6.2 Pyrogens . 3
6.3 Haemolysis . 3
7 Packaging . 3
8 Labelling . 3
8.1 General . 3
8.2 Label on unit container . 3
8.3 Label on shelf or multi-unit container . 4
9 Disposal . 4
Annex A (normative) Physical tests . 5
Annex B (normative
...
SLOVENSKI STANDARD
oSIST prEN ISO 8536-10:2013
01-december-2013
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO 'RGDWNL]DªIOXLGQH©FHYNH]D
HQNUDWQRXSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND ,62',6
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use
with pressure infusion equipment (ISO/DIS 8536-10:2013)
Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für
Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten
(ISO/DIS 8536-10:2013)
Matériel de perfusion à usage médical - Partie 10: Accessoires de tubulures pour
utilisation avec des appareils de perfusion sous pression (ISO/DIS 8536-10:2013)
Ta slovenski standard je istoveten z: prEN ISO 8536-10
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-10:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-10:2013
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-10:2013
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ISO/DIS 8536-10
ISO/TC 76 Secretariat: DIN
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2013-09-26 2014-02-26
Infusion equipment for medical use —
Part 10:
Accessories for fluid lines for single use with pressure
infusion equipment
Matériel de perfusion à usage médical —
Partie 10: Accessoires de tubulures non réutilisables avec des appareils de perfusion sous pression
[Revision of first edition (ISO 8536-10:2004)]
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ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
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---------------------- Page: 3 ----------------------
oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10:2013(E)
Copyright notice
��is������������t�is����r�ft���t�r��ti������t����r������is�����ri��t-�r�t��t����������������t��s�
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
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---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10
Contents Page
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Designation . 1
4 Materials . 2
5 Physical requirements . 2
5.1 Avoidance of air bubbles . 2
5.2 Particulate contamination. 2
5.3 Tensile strength . 3
5.4 Leakage . 3
5.5 Adapters with female and/or male conical fittings . 3
5.6 Protective caps . 3
5.7 Manipulation of stopcocks . 3
5.8 Unit with injection site . 3
5.9 Unit with check valve . 3
6 Chemical requirements . 3
7 Biological requirements . 3
7.1 Sterility. 3
7.2 Pyrogens . 3
7.3 Haemolysis . 4
8 Packaging . 4
9 Labelling . 4
9.1 General . 4
9.2 Label on unit container . 4
9.3 Label on shelf or multi-unit container . 5
Annex A (normative) Physical tests . 6
Annex B (normative) Chemical tests . 7
Annex C (normative) Biological tests . 8
Bibliography . 9
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices . 10
© ISO 2013 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10
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 are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
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.
ISO 8536-10 was prepared by Technical Committee 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 8536-10:2004), of which A.4 Tests for leakage
has been amended and A.5 specifying a test for leakage of adapters with female and/or male conical fittings
has been deleted. Clause 9 on labelling was amended by a note regarding the usage of the symbol "XXX"
according ISO 7000-2725. Finally some minor editorial changes were introduced in the whole document.
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
Part 7: Caps made of aluminium-plastics combinations for infusion bottles
Part 8: Infusion equipment 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:
iv © ISO 2013 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10
Part 13: Graduated flow regulators for single use with infusion sets
© ISO 2013 – All rights reserved v
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oSIST prEN ISO 8536-10:2013
---------------------- Page: 8 ----------------------
oSIST prEN ISO 8536-10:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 8536-10
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:
a) Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold
(SM);
NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions
can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of
possible stopcock positions, e. g. 3/4-way stopcock for three-way stopcock with four possible positions.
b) units with injection site (UIS) or check valve (UCV);
c) stoppers (S) or adapters (A).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 7886-1, Sterile hypodermic syringes for single use – Part 1: Syringes for manual use
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 set for single use with pressure infusion
apparatus
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
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):
© ISO 2013 – All rights reserved
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oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10
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):
Stopcock manifold ISO 8536-10 — 3SM — P
Designation of four-stopcock manifold (4SM) for infusions under pressure (P):
Stopcock manifo
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