EN ISO 3826-1:2013
CEN · 2013-06-01

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers

Replaced ICS 11.040.20 Cited by 3

1Key Takeaways

This part of ISO 3826 specifies requirements, including the required performance characteristics, for non-ventilated, sterile plastic bags equipped with a collection tube, one or more puncture nozzles, an integrated blood collection cannula and optionally with a transfer tube or tubes and which are used for collection,…

2Scope / Description

This part of ISO 3826 specifies requirements, including the required performance characteristics, for non-ventilated, sterile plastic bags equipped with a collection tube, one or more puncture nozzles, an integrated blood collection cannula and optionally with a transfer tube or tubes and which are used for collection, storage, processing and transport , intended for the separation and administration of blood and blood components. Depending on the intended use, the plastic bags may contain anticoagulant and/or stabilizer solution. This part of ISO 3826 is also applicable to multiple systems of plastic bags, e.g. B. composed of two, three, four or more units. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the ready-to-use plastic bag. This part of ISO 3826 does not apply to plastic bags with an integrated filter.

3Version History

FprEN ISO 3826-1:2013 older
EN ISO 3826-1:2003 older 2003
EN ISO 3826-1:2013 2013-06-01
EN ISO 3826-1:2019 newer 2019-10-16
EN ISO 3826-1:2019/A1:2023 Amd A1/2023 newer 2023-04-05

5Citation Network

3
Cite this standard
9
Referenced herein
93/42/EWG-1993 ISO 10993-10:2010 ISO 10993-11:2006 ISO 10993-12:2012 ISO 10993-1:2009 ISO 10993-4:2002 ISO 10993-5:2009 ISO 1135-4:2012

6Frequently Asked Questions

What is EN ISO 3826-1:2013?
EN ISO 3826-1:2013 — Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers is an international standard developed by European Committee for Standardization (CEN). This part of ISO 3826 specifies requirements, including the required performance characteristics, for non-ventilated, sterile plastic bags equipped with a collection tube, one or more puncture nozzles, an integrated blood collection cannula and...
What does EN ISO 3826-1:2013 cover?
This standard covers: This part of ISO 3826 specifies requirements, including the required performance characteristics, for non-ventilated, sterile plastic bags equipped with a collection tube, one or more puncture nozzles, an integrated blood collection cannula and optionally with a transfer tube or tubes and which are...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of EN ISO 3826-1:2013?
The current published version is EN ISO 3826-1:2013, published on 2013-06-01. Always check for amendments or pending revisions.
How do I purchase EN ISO 3826-1:2013?
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