SS-EN-ISO-3826-1 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

SS-EN-ISO-3826-1 - 2019 EDITION - CURRENT
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Included in this current edition are the following subparts:

 2019 EDITION - Oct. 22, 2019
 FOR 2019 EDITION AMENDMENT 1 SEE - April 11, 2023

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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)


Medical devices

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Designation Name

SS-EN ISO 3826-1:2019

Revision Level

2019 EDITION

Status

Current

Publication Date

Oct. 22, 2019

Language(s)

English

Page Count

36

International Equivalent

EN ISO 3826-1:2019(IDT); ISO 3826-1:2019(IDT)