EN ISO 8536-10:2004
(Main)Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment (ISO 8536-10:2004)
Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment (ISO 8536-10:2004)
ISO 8536-10:2004 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2004 includes:
Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold (SM). 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.
Units with injection site (UIS) or check valve (UCV).
Stoppers (S) or adapters (A).
Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für Übertragungsleitungen zur Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2004)
Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bestimmte und mit Druckinfusions-apparaten verwendete Zubehörteile für Übertragungsleitungen und Infusionsgeräte nach ISO 8536-8.
Von diesem Teil von ISO 8536 werden erfasst:
a) Zweiwegehähne (2SC), Dreiwegehähne (3SC), Vierwegehähne (4SC) und Hahnbänke (SM);
ANMERKUNG Die Bezeichnung eines Hahns hängt von der Anzahl der Verbindungen ab. Die Anzahl der möglichen Funktionsstellungen kann zusätzlich durch einen Schrägstrich und darauffolgend durch die Zahl der möglichen Hahnstellungen erfolgen, z. B. 3/4-Wegehahn für einen Dreiwegehahn mit vier möglichen Stellungen.
b) Zuspritzteil mit Septum (UIS) oder Ventil (UCV);
c) Stopfen (S) oder Adapter (A).
Matériel de perfusion à usage médical - Partie 10: Accessoires de tubulures pour utilisation avec des appareils de perfusion sous pression (ISO 8536-10:2004)
L'ISO 8536-10:2004 s'applique aux accessoires à usage unique stériles des tubulures et appareils de perfusion sous pression spécifiés dans l'ISO 8536-8.
L'ISO 8536-10:2004 traite des éléments suivants:
les robinets à deux (2SC), trois (3SC), quatre (4SC) voies et les rampes de robinets (SM). La désignation d'un robinet dépend du nombre de raccordements. Le nombre de positions possibles de fonctionnement peut être exprimé en ajoutant une note complémentaire, à l'aide d'une barre oblique et d'un chiffre indiquant le nombre de positions possibles pour le robinet, par exemple, robinet à 3/4 voies, pour un robinet à trois voies comportant quatre positions possibles.
les unités avec site d'injection (UIS) ou avec valve anti-retour (UCV);
les bouchons (S) ou les adaptateurs (A).
Infuzijska oprema za uporabo v medicini - 10. del: Dodatki za »fluidne« cevke za uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-9:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO 'RGDWNL]DªIOXLGQH©FHYNH]D
XSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND ,62
Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with
pressure infusion equipment (ISO 8536-10:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für
Übertragungsleitungen zur Verwendung mit Druckinfusionsapparaten (ISO 8536-
10:2004)
Matériel de perfusion a usage médical - Partie 10: Accessoires de tubulures pour
utilisation avec des appareils de perfusion sous pression (ISO 8536-10:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-10:2004
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.
EUROPEAN STANDARD
EN ISO 8536-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2004
ICS 11.040.20
English version
Infusion equipment for medical use - Part 10: Accessories for
fluid lines for use with pressure infusion equipment (ISO 8536-
10:2004)
Matériel de perfusion à usage médical - Partie 10:
Accessoires de tubulures pour utilisation avec des
appareils de perfusion sous pression (ISO 8536-10:2004)
This European Standard was approved by CEN on 30 September 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-10:2004: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 8536-10:2004) 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 BSI.
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 June 2005, and conflicting national standards
shall be withdrawn at the latest by June 2005.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 8536-10:2004 has been approved by CEN as EN ISO 8536-10:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 8536-10
First edition
2004-10-01
Infusion equipment for medical use —
Part 10:
Accessories for fluid lines for use with
pressure infusion equipment
Matériel de perfusion à usage médical —
Partie 10: Accessoires de tubulures pour utilisation avec des appareils
de perfusion sous pression
Reference number
ISO 8536-10:2004(E)
©
ISO 2004
ISO 8536-10:2004(E)
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©
ii ISO 2004 – All rights reserved
ISO 8536-10:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Designation . 2
4 Materials . 2
5 Physical requirements . 2
5.1 Avoidance of air bubbles . 2
5.2 Particulate contamination . 3
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 . 4
7.1 Sterility . 4
7.2 Pyrogens . 4
7.3 Haemolysis . 4
8 Packaging . 4
9 Labelling . 4
9.1 Unit container . 4
9.2 Shelf or multi-unit container . 5
Annex A (normative) Physical tests . 6
Annex B (normative) Chemical tests . 8
Annex C (normative) Biological tests . 9
Bibliography . 10
©
ISO 2004 – All rights reserved iii
ISO 8536-10:2004(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 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 equipment
for medical and pharmaceutical use.
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 use with pressure infusion apparatus
— Part 9: Fluid lines for use with pressure infusion equipment
— Part 10: Accessories for fluid lines for use with pressure infusion equipment
— Part 11: Infusion filters for use with pressure infusion equipment
©
iv ISO 2004 – All rights reserved
INTERNATIONAL STANDARD ISO 8536-10:2004(E)
Infusion equipment for medical use —
Part 10:
Accessories for fluid lines for use with pressure infusion
equipment
1Scope
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 referenced documents are indispensable for the application of this document. 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 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 equipment for use with pressure infusion
apparatus
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
©
ISO 2004 – All rights reserved 1
ISO 8536-10:2004(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) fo
...
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