Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

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.

Infusionsgeräte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2015)

Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bis 200 kPa (2 bar) bestimmte und mit Übertragungsleitungen von Druckinfusionsapparaten und Infusionsgeräten nach ISO 8536-8 verwendete Infusionsfilter. Diese Norm befasst sich nicht mit der Wirksamkeit von Filtern zur Abscheidung von Partikeln oder Keimen.
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 11 : Filtres à perfusion non réutilisables avec un matériel de perfusion sous pression (ISO 8536-11:2015)

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.

Infuzijska oprema za uporabo v medicini - 11. del: Infuzijski filtri za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-11:2015)

Ta del standarda ISO 8536 se uporablja za sterilizirane infuzijske filtre za enkratno uporabo do 200 kPa (2 bara) s »fluidnimi« cevkami in infuzijsko opremo, delujočo na osnovi tlaka, ter infuzijskim setom, kot je opredeljeno v standardu ISO 8536-8. Ne zajema učinkovitosti filtrov za ločevanje delcev ali bacilov.
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 8536-11:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-11:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLILOWUL]DHQNUDWQR
XSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND ,62
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure
infusion equipment (ISO 8536-11:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur einmaligen
Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2015)
Matériel de perfusion à usage médical - Partie 11: Filtres à perfusion non réutilisables
avec un matériel de perfusion sous pression (ISO 8536-11:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-11:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-11:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8536-11:2015

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

SIST EN ISO 8536-11:2015

EUROPEAN STANDARD
EN ISO 8536-11

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-11:2004
English Version
Infusion equipment for medical use - Part 11: Infusion filters for
single use with pressure infusion equipment (ISO 8536-11:2015)
Matériel de perfusion à usage médical - Partie 11 : Filtres à Infusionsgeräte zur medizinischen Verwendung - Teil 11:
perfusion non réutilisables avec un matériel de perfusion Infusionsfilter zur einmaligen Verwendung mit
sous pression (ISO 8536-11:2015) Druckinfusionsapparaten (ISO 8536-11:2015)
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 8536-11:2015 E
worldwide for CEN national Members.

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

SIST EN ISO 8536-11:2015
EN ISO 8536-11:2015 (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 8536-11:2015
EN ISO 8536-11:2015 (E)
European foreword
This document (EN ISO 8536-11:2015) 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 8536-11:2004.
— 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/o
...

SLOVENSKI STANDARD
oSIST prEN ISO 8536-11:2013
01-december-2013
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLILOWUL]DHQNUDWQR
XSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND ,62',6
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure
infusion equipment (ISO/DIS 8536-11:2013)
Infusionsgeräte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur einmaligen
Verwendung mit Druckinfusionsapparaten (ISO/DIS 8536-11:2013)
Matériel de perfusion à usage médical - Partie 11: Filtres à perfusion non réutilisables
avec un matériel de perfusion sous pression (ISO/DIS 8536-11:2013)
Ta slovenski standard je istoveten z: prEN ISO 8536-11
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-11:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-11:2013

---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-11:2013
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ISO/DIS 8536-11
ISO/TC 76 Secretariat: DIN
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2013-09-26 2014-02-26
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 de perfusion non réutilisables avec des appareils de perfusion sous pression
[Revision of first edition (ISO 8536-11:2004)]
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oSIST prEN ISO 8536-11:2013
ISO/DIS 8536-11:2013(E)

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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 8536-11:2013
ISO/DIS 8536-11
Contents Page
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Designation . 1
4 Design . 1
5 Materials .
...

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