SIST EN ISO 3826-1:2019/A1:2023

SLOVENSKI STANDARD
01-junij-2023
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni
vsebniki - Dopolnilo A1 (ISO 3826-1:2019/Amd 1:2023)
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel - Änderung 1 (ISO 3826-1:2019/Amd 1:2023)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles - Amendement 1 (ISO 3826-1:2019/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2019/A1:2023
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 3826-1:2019/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2023
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers -
Amendment 1 (ISO 3826-1:2019/Amd1:2023)
Poches en plastique souple pour le sang et les Kunststoffbeutel für menschliches Blut und
composants du sang - Partie 1: Poches Blutbestandteile - Teil 1: Konventionelle Beutel -
conventionnelles - Amendement 1 (ISO 3826- Änderung 1 (ISO 3826-1:2019/Amd 1:2023)
1:2019/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 3826-1:2019; it was approved by CEN on 30 January 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2019/A1:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 3826-1:2019/A1:2023) 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 October 2023, and conflicting national standards shall
be withdrawn at the latest by October 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 3826-1:2019/Amd 1:2023 has been approved by CEN as EN ISO 3826-1:2019/A1:2023
without any modification.
INTERNATIONAL ISO
STANDARD 3826-1
Third edition
2019-09
AMENDMENT 1
2023-03
Plastics collapsible containers
for human blood and blood
components —
Part 1:
Conventional containers
AMENDMENT 1
Poches en plastique souple pour le sang et
...