Standard Swedish standard · SS-EN ISO 3826-1:2019/A1:2023

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)

Status: Valid

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Standard Swedish standard · SS-EN ISO 3826-1:2019/A1:2023

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
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Scope
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.
This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


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Standard Swedish standard · SS-EN ISO 3826-1:2019/A1:2023

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
Subscribe on standards - Read more Dölj
Price: 700 SEK
standard ikon pdf

PDF

Price: 700 SEK
standard ikon

Paper

Price: 1 120 SEK
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PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80042105

Edition: 1

Approved: 4/11/2023

No of pages: 12

Amendment: SS-EN ISO 3826-1:2019