Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)

2012-07-23 GVN: draft for // vote received in ISO/CS (see notification of 2012-07-23 in dataservice).
2011-11-04 EMA: draft for // ENQ received in ISO/CS (see notification of 2011-11-01 in dataservice).

Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010/Amd 1:2013)

Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2010/Amd 1:2013)

Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije - Dopolnilo A1 (ISO 8536-4:2010/Amd 1:2013)

Ta del standarda ISO 8536 določa zahteve za infuzijske sete za enkratno uporabo, delujoče na osnovi gravitacije, za uporabo v medicini za zagotavljanje združljivosti z vsebniki za infuzijske raztopine in intravenozno opremo. Druga cilja tega dela standarda ISO 8536 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za infuzijske sete, ter predstaviti oznake za sestavne dele transfuzijskih setov. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.

General Information

Status
Withdrawn
Publication Date
05-Mar-2013
Withdrawal Date
28-Jan-2020
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
29-Jan-2020

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-4:2013/A1:2013
01-junij-2013
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH'RSROQLOR$ ,62$PG

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010/Amd 1:2013)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010/Amd 1:2013)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2013/A1:2013
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-4:2013/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 8536-4:2013/A1:2013

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

SIST EN ISO 8536-4:2013/A1:2013


EUROPEAN STANDARD
EN ISO 8536-4:2013/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2013
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2010/Amd 1:2013) Verwendung (ISO 8536-4:2010/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 8536-4:2013; it was approved by CEN on 9 February 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2013/A1:2013: E
worldwide for CEN national Members.

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SIST EN ISO 8536-4:2013/A1:2013
EN ISO 8536-4:2013/A1:2013 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

2

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SIST EN ISO 8536-4:2013/A1:2013
EN ISO 8536-4:2013/A1:2013 (E)
Foreword
This document (EN ISO 8536-4:2013/A1:2013) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing 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 September 2013, and conflicting national standards shall be
withdrawn at the latest by September 2013.
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 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN-CENELEC
...

SLOVENSKI STANDARD
SIST EN ISO 8536-4:2010/oprA1:2012
01-februar-2012
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH ,62'$0
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010/DAM 1:2011)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010/DAM 1:2011)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010/DAM 1:2011)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2010/prA1
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-4:2010/oprA1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 8536-4:2010/oprA1:2012

---------------------- Page: 2 ----------------------
SIST EN ISO 8536-4:2010/oprA1:2012


EUROPEAN STANDARD
DRAFT
EN ISO 8536-4:2010
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
December 2011
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010/DAM 1:2011)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2010/DAM 1:2011) Verwendung (ISO 8536-4:2010/DAM 1:2011)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 205.

This draft amendment A1, if approved, will modify the European Standard EN ISO 8536-4:2010. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2010/prA1:2011: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 8536-4:2010/oprA1:2012
EN ISO 8536-4:2010/prA1:2011 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 8536-4:2010/oprA1:2012
EN ISO 8536-4:2010/prA1:2011 (E)
Foreword
This document (EN ISO 8536-4:2010/prA1:2011) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO 8536-4:2010/DAM 1:2011 has been approved by CEN as a EN ISO 8536-4:2010/prA1:2011
without any modification.

3

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SIST EN ISO 8536-4:2010/oprA1:2012

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SIST EN ISO 8536-4:2010/oprA1:2012

DRAFT AMENDMENT ISO 8536-4:2010/DAM 1
ISO/TC 76 Secretariat: DIN
Voting begins on
...

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