SIST EN ISO 8871-2:2005/A1:2014
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003/Amd.1:2005)
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 2: Identification et caractérisation - Amendement 1 (ISO 8871-2:2003/Amd 1:2005)
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in opredelitev - Dopolnilo A1 (ISO 8871-2:2003/Amd 1:2005)
Ta del standarda ISO 8871 določa evaluacijske postopke za dele iz elastomera, ki se uporabljajo za vsebnike za zdravila in medicinske pripomočke za zagotovitev identitete izdelka med vzorci, ocenjenimi med postopkom sprejemanja (preskus primernosti), in trenutno zalogo. Postopki za fizične in kemične preskuse, določeni v tem delu standarda ISO 8871, dovoljujejo določitev tipičnih lastnosti materialov iz gume in lahko služijo kot osnova za dogovore med proizvajalcem in uporabnikom glede konsistence izdelka v nadaljnjih zalogah. Izbran je nabor ustreznih preskusov glede na tip gume in njeno uporabo. Ta del ISO 8871 ne določa drugih zahtev za materiale iz gume. Ti so obravnavani v standardih za ustrezne izdelke.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8871-2:2005/A1:2014
01-oktober-2014
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in
opredelitev - Dopolnilo A1 (ISO 8871-2:2003/Amd 1:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2:
Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003/Amd.1:2005)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 2: Identification et caractérisation - Amendement 1 (ISO 8871-
2:2003/Amd 1:2005)
Ta slovenski standard je istoveten z: EN ISO 8871-2:2004/A1:2014
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-2:2005/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8871-2:2005/A1:2014
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SIST EN ISO 8871-2:2005/A1:2014
EUROPEAN STANDARD
EN ISO 8871-2:2004/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2014
ICS 11.040.20
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 2: Identification and characterization -
Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
Éléments en élastomère pour administration parentérale et Elastomere Teile für Parenteralia und für Geräte zur
dispositifs à usage pharmaceutique - Partie 2: Identification pharmazeutischen Verwendung - Teil 2: Identifizierung und
et caractérisation - Amendement 1 (ISO 8871-2:2003/Amd Charakterisierung (ISO 8871-2:2003/Amd.1:2005)
1:2005)
This amendment A1 modifies the European Standard EN ISO 8871-2:2004; it was approved by CEN on 24 May 2014.
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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-2:2004/A1:2014 E
worldwide for CEN national Members.
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SIST EN ISO 8871-2:2005/A1:2014
EN ISO 8871-2:2004/A1:2014 (E)
Contents Page
Foreword . 3
2
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SIST EN ISO 8871-2:2005/A1:2014
EN ISO 8871-2:2004/A1:2014 (E)
Foreword
This document (EN ISO 8871-2:2004/A1:2014) 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 Amendment to the European Standard EN ISO 8871-2:2004 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2014, and
conflicting national standards shall be withdrawn at the latest by December 2014.
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.
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.
Endorsement notice
The text of ISO 8871-2:2003/Amd 1:2005: has been approved by CEN as EN ISO 8871-2:2005/A1:2014
without any modification.
3
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SIST EN ISO 8871-2:2005/A1:2014
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SIST EN ISO 8871-2:2005/A1:2014
INTERNATIONAL ISO
STANDARD 8871-2
First edition
2003-10-01
AMENDMENT 1
2005-07-15
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 2:
Identification and characterization
AMENDMENT 1
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 2: Identification et caractérisation
AMENDEMENT 1
Reference number
ISO 8871-2:2003/Amd.1:2005(E)
©
ISO 2005
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SIST EN ISO 8871-2:2005/A1:2014
ISO 8871-2:2003/Amd.1:2005(E)
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