SIST EN ISO 3826-1:2019/A1:2023
(Amendment)Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
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)
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni vsebniki - Dopolnilo A1 (ISO 3826-1:2019/Amd 1:2023)
General Information
Relations
Overview
EN ISO 3826-1:2019/A1:2023 is the CEN-endorsed amendment to the international standard for plastics collapsible containers for human blood and blood components - Part 1: Conventional containers. Published April 2023 and prepared by ISO/TC 76 in collaboration with CEN/TC 205, this amendment adds requirements and clarifications for the instructions for use, freezing (primarily plasma-freezing bags) and ionizing irradiation of blood bags. The amendment is intended to be adopted as a national standard across CEN member bodies.
Key topics and technical requirements
- Instructions for use: Manufacturers must state whether a plastics container is intended for freezing and/or irradiation and reference applicable regulatory guidance (e.g., EDQM).
- Freezing (plasma-focused):
- Test condition: container filled to half nominal capacity with water (per ISO 3696).
- Must withstand slow freezing and storage to −80 °C for 24 h, immersion at (37 ± 2) °C for 60 min, and return to (23 ± 2) °C.
- Post‑test compliance with specified clauses (e.g., physical integrity and leakage tests) is required.
- Shock/blast freezing requires separate validation.
- Use of refrigerant solutions is permitted if a protective bag prevents direct contact with the container.
- Ionizing irradiation (irradiated blood components):
- Test condition: container filled to nominal capacity (containers >350 ml limited to 350 ml for the test).
- Containers must withstand the maximum irradiation dose specified in the amendment and meet post‑irradiation performance requirements.
- Integrity and performance following irradiation must be validated for the intended application.
- Referenced test methods: Water quality per ISO 3696 and other clauses from ISO 3826‑1 (as cited) apply.
Applications and who uses this standard
- Medical device and blood bag manufacturers: design, testing and labeling of plastic blood bags intended for freezing or irradiation.
- Blood banks and transfusion services: selection and qualification of containers for plasma freezing and storage or for irradiated blood components.
- Quality assurance / validation engineers: develop validation protocols for freeze‑thaw cycles, blast freezing, refrigerant handling and irradiation processes.
- Regulatory and procurement teams: ensure compliance with harmonized European and international requirements for transfusion and infusion equipment.
Related standards and references
- ISO 3826 series (other parts)
- ISO 3696 (water for laboratory use)
- EDQM Guide to preparation, use and quality assurance of blood components
- ISO/TC 76 and CEN/TC 205 publications
Keywords: EN ISO 3826-1:2019/A1:2023, plastics collapsible containers, blood bags, plasma freezing, irradiation, blood components, validation, transfusion equipment.
Frequently Asked Questions
SIST EN ISO 3826-1:2019/A1:2023 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)". This standard covers: Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
SIST EN ISO 3826-1:2019/A1:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 3826-1:2019/A1:2023 has the following relationships with other standards: It is inter standard links to SIST EN ISO 3826-1:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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Standards Content (Sample)
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
...
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