EN ISO 8871-3:2004/A1:2019

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 3: Bestimmung von herausgelösten Partikeln - Änderung 1 (ISO 8871-3:2003/Amd 1:2018)

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 3: Détermination des particules libérées - Amendement 1 (ISO 8871-3:2003/Amd 1:2018)

Deli iz elastomera za parenteralne farmacevtske oblike - 3. del: Ugotavljanje deleža sproščenih delcev - Dopolnilo A1 (ISO 8871-3:2003/Amd 1:2018)

General Information

• Status: Published
• Publication Date: 26-Mar-2019
• Withdrawal Date: 29-Sep-2019
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Mar-2019
• Completion Date: 27-Mar-2019
• Ref Project: SIST EN ISO 8871-3:2004/A1:2019 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)

Relations

• Amends: EN ISO 8871-3:2004 - Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
• Effective Date: 04-Apr-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2019
'HOLL]HODVWRPHUD]DSDUHQWHUDOQHIDUPDFHYWVNHREOLNHGHO8JRWDYOMDQMHGHOHåD
VSURãþHQLKGHOFHY'RSROQLOR$,62$PG
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3:
Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 3: Bestimmung von herausgelösten Partikeln - Änderung 1 (ISO 8871-3:2003/Amd
1:2018)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 3: Détermination des particules libérées - Amendement 1 (ISO
8871-3:2003/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 8871-3:2004/A1:2019
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.

EN ISO 8871-3:2004/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 3: Determination of released-
particle count - Amendment 1 (ISO 8871-3:2003/Amd
1:2018)
Éléments en élastomère pour administration Elastomere Teile für Parenteralia und für Geräte zur
parentérale et dispositifs à usage pharmaceutique - pharmazeutischen Verwendung - Teil 3: Bestimmung
Partie 3: Détermination des particules libérées - von herausgelösten Partikeln - Änderung 1 (ISO 8871-
Amendement 1 (ISO 8871-3:2003/Amd 1:2018) 3:2003/Amd 1:2018)
This amendment A1 modifies the European Standard EN ISO 8871-3:2004; it was approved by CEN on 29 November 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-3:2004/A1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 8871-3:2003/Amd 1:2018 has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use” of the International Organization for Standardization (ISO) and has been taken over as
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 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organiza
...