Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)

ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2015 includes the following:
a)    two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
b)    units with injection site or check valve;
c)    stoppers or adapters.

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 pour tubulures non réutilisables avec un matériel 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

Status
Published
Publication Date
16-Jun-2015
Withdrawal Date
30-Dec-2015
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
17-Jun-2015
Completion Date
17-Jun-2015

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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

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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
...

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
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oSIST prEN ISO 8536-10:2013
ISO/DIS 8536-10:2013(E)

Copyright notice
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permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
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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 .
...

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